21 U.S.C. 360hh-360ss.
References in this subchapter J to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
As used in this subchapter J:
(a)
(b)
(c)
(1) The same circuitry in the high voltage, horizontal oscillator, and power supply sections;
(2) The same worst component failures;
(3) The same type of high voltage hold-down or safety circuits; and
(4) The same design and installation.
(d)
(1) Commerce between any place in any State and any place outside thereof, and
(2) Commerce wholly within the District of Columbia.
(e)
(f)
(g)
(h)
(i)
(j)
(1) Any manufactured or assembled product which, when in operation:
(i) Contains or acts as part of an electronic circuit and
(ii) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(2) Any manufactured or assembled article that is intended for use as a component, part, or accessory of a product described in paragraph (j)(1) of this section and which, when in operation, emits (or in the absence of effective shielding or other controls would emit) such radiation.
(k)
(1) Any ionizing or nonionizing electromagnetic or particulate radiation, or
(2) Any sonic, infrasonic, or ultrasonic wave that is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(1) Charged particles, such as protons, electrons, alpha particles, or heavy particles, which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions or electrical repulsion; or
(2) Uncharged particles, such as neutrons, which can initiate a nuclear transformation or liberate charged particles having sufficient kinetic energy to produce ionization or atomic or electron excitation.
(s)
(t)
(u)
The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which the regulations of this part apply.
(a) Examples of electronic products which may emit x-rays and other ionizing electromagnetic radiation, electrons, neutrons, and other particulate radiation include:
(b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio and low frequency electromagnetic radiation include:
(c) Examples of electronic products which may emit coherent electromagnetic radiation produced by stimulated emission include:
(d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include:
Specific area gonad shielding covers an area slightly larger than the region of the gonads. It may therefore be used without interfering with the objectives of the examination to protect the germinal tissue of patients from radiation exposure that may cause genetic mutations during many medical x-ray procedures in which the gonads lie within or are in close proximity to the x-ray field. Such shielding should be provided when the following conditions exist:
(a) The gonads will lie within the primary x-ray field, or within close proximity (about 5 centimeters), despite proper beam limitation. Except as provided in paragraph (b) or (c) of this section:
(1) Specific area testicular shielding should always be used during those examinations in which the testes usually are in the primary x-ray field, such as examinations of the pelvis, hip, and upper femur;
(2) Specific area testicular shielding may also be warranted during other examinations of the abdominal region in which the testes may lie within or in close proximity to the primary x-ray field, depending upon the size of the patient and the examination techniques and equipment employed. Some examples of these are: Abdominal, lumbar spine and lumbosacral spine examinations, intravenous pyelograms, and abdominal scout film for barium enemas and upper GI series. Each x-ray facility should evaluate its procedures, techniques, and equipment and compile a list of such examinations for which specific area testicular shielding should be routinely considered for use. As a basis for judgment, specific area testicular shielding should be considered for all examinations of male patients in which the pubic symphysis will be visualized on the film;
(3) Specific area gonad shielding should never be used as a substitute for careful patient positioning, the use of correct technique factors and film processing, or proper beam limitation (confinement of the x-ray field to the area of diagnostic interest), because this could result in unnecessary doses to other sensitive tissues and could adversely affect the quality of the radiograph; and
(4) Specific area gonad shielding should provide attenuation of x-rays at least equivalent to that afforded by 0.25 millimeter of lead.
(b) The clinical objectives of the examination will not be compromised.
(1) Specific area testicular shielding usually does not obscure needed information except in a few cases such as oblique views of the hip, retrograde urethrograms and voiding cystourethrograms, visualization of the rectum and, occasionally, the pubic symphysis. Consequently, specific area testicular shielding should be considered for use in the majority of x-ray examinations of male patients in which the testes will lie within the primary beam or within 5 centimeters of its edge. It is not always possible to position shields on male patients so that no bone is obscured. Therefore, if all bone structure of the pelvic area must be visualized for a particular patient, the use of shielding should be carefully evaluated. The decision concerning the applicability of shielding for an individual patient is dependent upon consideration of the patient's unique anthropometric characteristics and the diagnostic information needs of the examination.
(2) The use of specific area ovarian shielding is frequently impractical at present because the exact location of the ovaries is difficult to estimate, and the shield may obscure visualization of portions of adjacent structures such as the spine, ureters, and small and large bowels. However, it may be possible for
(c) The patient has a reasonable reproductive potential.
(1) Specific area shielding need not be used on patients who cannot or are not likely to have children in the future.
(2) The following table of statistical data regarding the average number of children expected by potential parents in various age categories during their remaining lifetimes is provided for x-ray facilities that wish to use it as a basis for judging reproductive potential:
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(c)
(1)
(ii) The owner or practitioner in charge of the facility has primary responsibility for implementing and maintaining the quality assurance program.
(iii) Staff technologists will generally be delegated a basic quality assurance role by the practitioner in charge. Responsibility for specific quality control monitoring and maintenance techniques or quality administration procedures may be assigned, provided that the staff technologists are qualified by training or experience for these duties. The staff technologists should also be responsible for identifying problems or potential problems requiring actions beyond the level of their training. They should bring these problems to the attention of the practitioner in charge, or his or her representative, so that assistance in solving the problems may be obtained from inside or outside the facility.
(iv) In facilities where they are available, physicists, supervisory technologists, or quality control technologists should have a major role in the quality assurance program. Such specialized personnel may be assigned responsibility for day-to-day administration of the program, may carry out monitoring duties beyond the level of training of the staff technologist or, if desired by the facility, may relieve the staff technologists of some or all of their basic monitoring duties. Staff service engineers may also be assigned responsibility for certain preventive or corrective maintenance actions.
(v) Responsibility for certain quality control techniques and corrective measures may be assigned to personnel qualified by training or experience, such as consultants or industrial representatives, from outside of the facility, provided there is a written agreement clearly specifying these services.
(vi) In large facilities, responsibility for long-range planning of quality assurance goals and activities should be assigned to a quality assurance committee as described in paragraph (c)(9) of this section.
(2)
(3)
(i) The parameters to be monitored in a facility should be determined by that facility on the basis of an analysis of expected benefits and cost. Such factors as the size and resources of the facility, the type of examinations conducted, and the quality assurance problems that have occurred in that or similar facilities should be taken into account in establishing the monitoring system. The monitoring frequency should also be based upon need and can be different for different parameters.
(ii) Although the parameters to be monitored will vary somewhat from facility to facility, every diagnostic radiology facility should consider monitoring the following five key components of the x-ray system:
(
(
(
(
(
(iii) Examples of parameters of the above-named components and of more specialized equipment that may be monitored are as follows:
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(iv) The maintenance program should include both preventive and corrective aspects.
(4)
(5)
(i) On the first level, the results of the monitoring procedures should be used to evaluate the performance of the x-ray system(s) to determine whether corrective actions are needed to adjust the equipment so that the image quality consistently meets the standards for image quality. This evaluation should include analysis of trends in the monitoring data as well as the use of the data to determine the need for corrective actions on a day-by-day basis. Comparison of monitoring data with the purchase specifications and acceptance testing results for the equipment in question is also useful.
(ii) On the second level, the facility quality assurance program should also include means for evaluating the effectiveness of the program itself. Possible means include ongoing studies of the retake rate and the causes of the repeated radiographs, examination of equipment repair and replacement costs, subjective evaluation of the radiographs being produced, occurrence and reasons for complaints by radiologists, and analysis of trends in the results of monitoring procedures such as sensitometric studies. Of these, ongoing studies of the retake rate (reject rate) and its causes are often the most useful and may also provide information of value in the first level of evaluation. Such studies can be used to evaluate potential for improvement, to make corrections, and to determine whether the corrective actions were effective. The number of rejects should be recorded daily or weekly, depending on the facility's analysis of its needs. Ideally, the reasons for the rejection
(6)
(7)
(i) A list of the individuals responsible for monitoring and maintenance techniques.
(ii) A list of the parameters to be monitored and the frequency of monitoring.
(iii) A description of the standards, criteria of quality, or limits of acceptability that have been established for each of the parameters monitored.
(iv) A brief description of the procedures to be used for monitoring each parameter.
(v) A description of procedures to be followed when difficulties are detected to call these difficulties to the attention of those responsible for correcting them.
(vi) A list of the publications in which detailed instructions for monitoring and maintenance procedures can be found. Copies of these publications should also be readily available to the entire staff, but they should be separate from the manual. (Publications providing these instructions can usually be obtained from FDA or private sources, although the facility may wish to make some modifications to meet its needs more effectively.)
(vii) A list of the records, with sample forms, that the facility staff has decided should be kept. The facility staff should also determine and note in the manual the length of time each type of record should be kept before discarding.
(viii) A copy of each set of purchase specifications developed for new equipment and the results of the acceptance testing for that equipment.
(8)
(9)
(10)
(i) The reports of the monitoring and maintenance techniques to ensure that they are being performed on schedule and effectively. These reports should be reviewed at least quarterly.
(ii) The monitoring and maintenance techniques and their schedules to ensure that they continue to be appropriate and in step with the latest developments in quality assurance. They should be made current at least annually.
(iii) The standards for image quality to ensure that they are consistent with the state-of-the-art and the needs and resources of the facility. These standards should be evaluated at least annually.
(iv) The results of the evaluations of the effectiveness of the quality assurance actions to determine whether changes need to be made. This determination should be made at least annually.
(v) The quality assurance manual should also be reviewed at least annually to determine whether revision is needed.
(a) The Food and Drug Administration recommends that dental x-ray examinations be performed only after careful consideration of the dental or other health needs of the patient, that is, when the patient's dentist or physician judges them to be necessary for diagnosis, treatment, or prevention of disease. Administratively required dental x-ray examinations are those required by a remote third party for reasons not related to the patient's immediate dental needs. These x-ray examinations are usually a source of unnecessary radiation exposure to the patient. Because any unnecessary radiation exposure should be avoided, third parties should not require dental x-ray examinations unless they can demonstrate that such examinations provide a direct clinical benefit to the patient, and the patient's dentist or physician agrees with that assessment.
(b) Some examples of administrative x-ray examinations that should not be required by third parties are those intended solely:
(1) To monitor insurance claims or detect fraud;
(2) To satisfy a prerequisite for reimbursement;
(3) To provide training or experience;
(4) To certify qualifications or competence.
(c) This recommendation is not intended to preclude dental x-ray examinations ordered by the attending practitioner, based on the patient's history or physical examination, or those performed on selected populations shown to have significant yields of previously undiagnosed disease. This recommendation is also not intended to preclude the administrative use by third parties of dental radiographs that are taken on the order of the patient's dentist or physician as a necessary part of the patient's clinical care.
21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.
The provisions of this part are applicable as follows:
(a) All manufacturers of electronic products are subject to § 1002.20.
(b) Manufacturers, dealers, and distributors of electronic products are subject to the provisions of part 1002 as set forth in table 1 of this section, unless excluded by paragraph (c) of this section, or unless an exemption has been granted under § 1002.50 or § 1002.51.
(c) The requirements of part 1002 as specified in table 1 of this section are not applicable to:
(1) Manufacturers of electronic products intended solely for export if such product is labeled or tagged to show that the product meets all the applicable requirements of the country to which such product is intended for export.
(2) Manufacturers of electronic products listed in table 1 of this section if such product is sold exclusively to other manufacturers for use as components of electronic products to be sold to purchasers, with the exception that the provisions are applicable to those manufacturers certifying components of diagnostic x-ray systems pursuant to provisions of § 1020.30(c) of this chapter.
(3) Manufacturers of electronic products that are intended for use by the U.S. Government and whose function or design cannot be divulged by the manufacturer for reasons of national security, as evidenced by government security classification.
(4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 1020.30(d) of this chapter, provided the assembler has submitted the report required by § 1020.30(d)(1) or (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.
As authorized by § 5.90 of this chapter, the Director and Deputy Director of the Center for Devices and Radiological Health may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser, at the time of original purchase, such performance data and other technical data related to safety of the product as the Director or Deputy Director finds necessary.
The Secretary or his representative shall not disclose any information reported to or otherwise obtained by him, pursuant to this part, which concerns or relates to a trade secret or other matter referred to in section 1905 of title 18 of the United States Code, except that such information may be disclosed to other officers or employees of the Department and of the other agencies concerned with carrying out the requirements of the Act. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his control, from the duly authorized committees of the Congress.
All submissions such as reports, test data, product descriptions, and other information required by this part, or voluntarily submitted to the Director, Center for Devices and Radiological Health, shall be filed with the number of copies as prescribed by the Director, Center for Devices and Radiological Health, and shall be signed by the person making the submission. The submissions required by this part shall be addressed to the Center for Devices and Radiological Health, Electronic Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850.
(a) In addition to the requirements of this part, all material submitted to the Director, Center for Devices and Radiological Health, shall be submitted pursuant to the provisions of part 20—Public Information, of this chapter.
(b) Where guides or instructions have been issued by the Director for the submission of material required by this part, such as test data, product reports, abbreviated reports, supplemental reports, and annual reports, the material submitted shall conform to the applicable reporting guides or instructions. Where it is not feasible or where it would not be appropriate to conform to any portion of a prescribed reporting guide or instruction, an alternate format for providing the information requested by that portion of the guide or instruction may be used provided the submitter of such information submits adequate explanation and justification for use of an alternate format. If the Director, Center for Devices and Radiological Health, determines that such justification is inadequate and that it is feasible or appropriate to conform to the prescribed reporting guide or instruction, he may require resubmission of the information in conformance with the reporting guide or instruction.
(c) Where the submission of quality control and testing information is common to more than one model, or model family of the same product category, a “common aspects report” consolidating similar information may be provided, if applicable.
Every manufacturer of a product or component requiring aproduct report as set forth in table 1 of § 1002.1 shall submit a product report to the Center for Devices and Radiological Health, Electronic Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850, prior to the introduction of such product into commerce. The report shall be distinctly
(a) Identify which listed product is being reported.
(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling to enable the Director to determine the place of manufacture.
(c) Include information on all components and accessories provided in, on, or with the listed product that may affect the quantity, quality, or direction of the radiation emissions.
(d) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product.
(e) State the standard or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a Federal standard, if applicable.
(f) For each model, describe the physical or electrical characteristics, such as shielding or electronic circuitry, incorporated into the product in order to meet the standards or specifications reported pursuant to paragraph (e) of this section.
(g) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures.
(h) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing of each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary.
(i) Provide sufficient results of the testing, measuring, and quality control procedures described in accordance with paragraphs (g) and (h) of this section to enable the Director to determine the effectiveness of those test methods and procedures.
(j) Report for each model all warning signs, labels, and instructions for installation, operation, and use that relate to electronic product radiation safety.
(k) Provide, upon request, such other information as the Director may reasonably require to enable him/her to determine whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Director to carry out the purposes of the Act.
Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of § 1002.1 for which a report under § 1002.10 is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in the information previously submitted in the product report. Reports will be required for changes that:
(a) Affect actual or potential radiation emission.
(b) Affect the manner of compliance with a standard or manner of testing for radiation safety.
Manufacturers of products requiring abbreviated reports as specified in table 1 of § 1002.1 shall submit, prior to the introduction of such product, a report distinctly marked “Radiation Safety Abbreviated Report” which shall include:
(a) Firm and model identification.
(b) A brief description of operational characteristics that affect radiation emissions, transmission, or leakage or that control exposure.
(c) A list of applications or uses.
(d) Radiation emission, transmission, or leakage levels.
(e) If necessary, additional information as may be requested to determine compliance with the Act and this part.
(a) Every manufacturer of products requiring an annual report as specified
(b) Reports are due annually by September 1. Such reports shall cover the 12-month period ending on June 30 preceding the due date of the report.
(c) New models of a model family that do not involve changes in radiation emission or requirements of a performance standard do not require supplemental reports prior to introduction into commerce. These model numbers should be reported in quarterly updates to the annual report.
(a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, immediately report to the Director, Center for Devices and Radiological Health, all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by such manufacturer. Reasonable grounds include, but are not necessarily limited to, professional, scientific, or medical facts or opinions documented or otherwise, that conclude or lead to the conclusion that such an incident has occurred.
(b) Such reports shall be addressed to the Director, Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857, and the reports and their envelopes shall be distinctly marked “Report on § 1002.20” and shall contain all of the following information where known to the manufacturer:
(1) The nature of the accidental radiation occurrence;
(2) The location at which the accidental radiation occurrence occurred;
(3) The manufacturer, type, and model number of the electronic product or products involved;
(4) The circumstances surrounding the accidental radiation occurrence, including causes;
(5) The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure and/or injuries and, if requested by the Director, Center for Devices and Radiological Health, the names of the persons involved;
(6) The actions, if any, which may have been taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence; and
(7) Any other pertinent information with respect to the accidental radiation occurrence.
(c) If a manufacturer is required to report to the Director under paragraph (a) of this section and also is required to report under part 803 of this chapter, the manufacturer shall report in accordance with part 803. If a manufacturer is required to report to the Director under paragraph (a) of this section and is not required to report under part 803, the manufacturer shall report in accordance with paragraph (a) of this section. A manufacturer need not file a separate report under this section if an incident involving an accidental radiation occurrence is associated with a defect or noncompliance and is reported pursuant to § 1003.10 of this chapter.
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:
(1) Description of the quality control procedures with respect to electronic product radiation safety.
(2) Records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the
(3) For those products displaying aging effects which may increase electronic product radiation emission, records of the results of tests for durability and stability of the product, and the basis for selecting these tests.
(4) Copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product.
(5) Data on production and sales volume levels if available.
(b) In addition to the records required by paragraph (a) of this section, manufacturers of products listed in paragraph (c) of § 1002.61 shall establish and maintain the following records with respect to such products:
(1) A record of the manufacturer's distribution of products in a form which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers.
(2) Records received from dealers or distributors pursuant to § 1002.41.
(a) Every manufacturer required to maintain -records pursuant to this part, including records received pursuant to § 1002.41, shall preserve such records for a period of 5 years from the date of the record.
(b) Upon reasonable notice by an officer or employee duly designated by the Department, manufacturers shall permit such officer or employee to inspect appropriate books, records, papers, and documents as are relevant to determining whether the manufacturer has acted or is acting in compliance with Federal standards.
(c) Upon request of the Director, Center for Devices and Radiological Health, a manufacturer of products listed in table 1 of § 1002.1 shall submit to the Director, copies of the records required to be maintained by paragraph (b) of § 1002.30.
(a) Dealers and distributors of electronic products for which there are performance standards and for which the retail price is $50 or more shall obtain such information as is necessary to identify and locate first purchasers if the product is subject to this section by virtue of table 1 of § 1002.1.
(b) Such information shall include:
(1) The name and mailing address of the distributor, dealer, or purchaser to whom the product was transferred.
(2) Identification and brand name of the product.
(3) Model number and serial or other identification number of the product.
(4) Date of sale, award, or lease.
(c) The information obtained pursuant to this section shall be forwarded immediately to the appropriate manufacturer of the electronic product, or preserved as prescribed in § 1002.41.
(a) Information obtained by dealers and distributors pursuant to § 1002.40 shall immediately be forwarded to the appropriate manufacturer unless:
(1) The dealer or distributor elects to hold and preserve such information and to immediately furnish it to the manufacturer when advised by the manufacturer or the Director, Center for Devices and Radiological Health, that such information is required for purposes of section 359 of the Act; and
(2) The dealer or distributor, upon making the election under paragraph (a)(1) of this section, promptly notifies the manufacturer of such election; such notification shall be in writing and shall identify the dealer or distributor and the electronic product or
(b) Every dealer or distributor who elects to hold and preserve information required pursuant to § 1002.40 shall preserve the information for a period of 5 years from the date of the sale, award, or lease of the product, or until the dealer or distributor discontinues dealing in, or distributing the product, whichever is sooner. If the dealer or distributor discontinues dealing in, or distributing the product, such information as obtained pursuant to § 1002.40 shall be furnished at that time, or before, to the manufacturer of the product.
All information furnished to manufacturers by dealers and distributors pursuant to this part shall be treated by such manufacturers as confidential information which may be used only as necessary to notify persons pursuant to section 359 of the Act.
(a) Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in table 1 of § 1002.1. The request must specify each requirement from which an exemption is requested. In addition to other information that is required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested does not pose a public health risk and meets at least one of the following criteria:
(1) The products cannot emit electronic product radiation in sufficient intensity or of such quality, under any conditions of operation, maintenance, service, or product failure, to be hazardous;
(2) The products are produced in small quantities;
(3) The products are used by trained individuals and are to be used by the same manufacturing corporation or for research, investigation, or training.
(4) The products are custom designed and used by trained individuals knowledgeable of the hazards; or
(5) The products are produced in such a way that the requirements are inappropriate or unnecessary.
(b) The Director may, subject to any conditions that the Director deems necessary to protect the public health, exempt manufacturers from all or part of the record and reporting requirements of this part on the basis of information submitted in accordance with paragraph (a) of this section or such other information which the Director may possess if the Director determines that such exemption is in keeping with the purposes of the Act.
(c) The Director will provide written notification of the reason for any denial. If the exemption is granted, the Director will provide written notification of:
(1) The electronic product or products for which the exemption has been granted;
(2) The requirements from which the product is exempted; and
(3) Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Office of Compliance (HFZ-307), Center for Devices and Radiological Health, 2098 Gaither Rd., Rockville, MD 20850.
(d) The Director may, on the Director's own motion, exempt certain classes of products from the reporting requirements listed in table 1 of § 1002.1, provided that the Director finds that such exemption is in keeping with the purposes of the act.
(e) Manufacturers of products for which there is no applicable performance standard under parts 1020 through 1050 of this chapter and for which an investigational device exemption has been approved under § 812.30 of this chapter or for which a premarket approval application has been approved in
Upon application therefor by the manufacturer, the Director, Center for Devices and Radiological Health, may exempt from the provisions of this part a manufacturer of any electronic product intended for use by departments or agencies of the United States provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the United States.
42 U.S.C. 263b-263n.
The provisions of this part are applicable to electronic products which were manufactured after October 18, 1968.
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:
(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;
(1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or
(2) It fails to conform to its design specifications relating to electronic radiation emissions; or
(b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it;
(1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or
(2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or
(3) Fails to accomplish the intended purpose.
The remedies provided for in this subchapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law.
Any manufacturer who discovers that any electronic product produced, assembled, or imported by him, which product has left its place of manufacture, has a defect or fails to comply with an applicable Federal standard shall:
(a) Immediately notify the Secretary in accordance with § 1003.20, and
(b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the following persons:
(1) The dealers or distributors to whom such product was delivered by the manufacturer; and
(2) The purchaser of such product and any subsequent transferee of such product (where known to the manufacturer or where the manufacturer upon reasonable inquiry to dealers, distributors, or purchasers can identify the present user).
(c) If a manufacturer is required to notify the Secretary under paragraph (a) of this section and also is required to report to the Food and Drug Administration under part 803 of this chapter, the manufacturer shall report in accordance with part 803. If a manufacturer is required to notify the Secretary under paragraph (a) of this section and is not required to report to the Food and Drug Administration under part 803, the manufacturer shall notify the Secretary in accordance with paragraph (a) of this section.
(a) If, the Secretary, through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable Federal standard issued pursuant to the Act or has a defect, he shall immediately notify the manufacturer of the product in writing specifying:
(1) The defect in the product or the manner in which the product fails to comply with the applicable Federal standard;
(2) The Secretary's findings, with references to the tests, inspections, studies, or reports upon which such findings are based;
(3) A reasonable period of time during which the manufacturer may present his views and evidence to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of electronic product radiation.
(b) Every manufacturer who receives a notice under paragraph (a) of this section shall immediately advise the Secretary in writing of the total number of such product units produced and the approximate number of such product units which have left the place of manufacture.
(c) If, after the expiration of the period of time specified in the notice, the Secretary determines that the product has a defect or does not comply with an applicable Federal standard and the manufacturer has not applied for an exemption, he shall direct the manufacturer to furnish the notification to the persons specified in § 1003.10(b) in the manner specified in § 1003.21. The manufacturer shall within 14 days from the date of receipt of such directive furnish the required notification.
The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:
(a) Identification of the product or products involved;
(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;
(c) The expected usage for the product if known to the manufacturer;
(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;
(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;
(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;
(g) The date and circumstances under which the defect was discovered; and
(h) The identification of any trade secret information which the manufacturer desires kept confidential.
(a) The notification to the persons specified in § 1003.10(b) shall be in writing and, in addition to other relevant information which the Secretary may require, shall include:
(1) The information prescribed by § 1003.20 (a), (d), and instructions with respect to the use of the product pending the correction of the defect;
(2) A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply; and
(3) The following statement:
The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you.
(b) The envelope containing the notice shall not contain advertising or other extraneous material, and such mailings will be made in accordance with this section.
(1) No. 10 white envelopes shall be used, and the name and address of the manufacturer shall appear in the upper left corner of the envelope.
(2) The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle 3
(3) Envelopes with markings similar to those prescribed in this section shall not be used by manufacturers for mailings other than those required by this part.
(c) The notification shall be sent:
(1) By certified mail to purchasers of the product and to subsequent transferees.
(2) By certified mail or other more expeditious means to dealers and distributors.
(d) Where products were sold under a name other than that of the manufacturer of the product, the name of the individual or company under whose name the product was sold may be used in the notification required by this section.
(a) Every manufacturer of electronic products shall furnish to the Secretary a copy of all notices, bulletins, or other communications sent to the dealers or distributors of such manufacturers or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any defect in such product or any failure of such product to comply with an applicable Federal standard.
(b) In the event the Secretary deems the content of such notices to be insufficient to protect the public health and safety, the Secretary may require additional notice to such recipients, or may elect to make or cause to be made such notification by whatever means he deems appropriate.
(a) A manufacturer may at the time of giving the written confirmation required by § 1003.20 or within 15 days of the receipt of any notice from the Secretary pursuant to § 1003.11(a), apply for an exemption from the requirement of notice to the persons specified in § 1003.10(b).
(b) The application for exemption shall contain the information required by § 1003.20 and in addition shall set forth in detail the grounds upon which the exemption is sought.
(a) If, in the judgment of the Secretary, the application filed pursuant to § 1003.30 states reasonable grounds for an exemption from the requirement of notice, the Secretary shall give the manufacturer written notice specifying a reasonable period of time during which he may present his views and evidence in support of the application.
(b) Such views and evidence shall be confined to matters relevant to whether the defect in the product or its failure to comply with an applicable Federal standard is such as to create a significant risk of injury, including genetic injury, to any person and shall be presented in writing unless the Secretary determines that an oral presentation is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall include, with respect to each such study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. When such evidence includes clinical investigations involving human subjects, the data submitted shall include, with respect to each clinical investigation either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105, and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.
(c) If, during the period of time afforded the manufacturer to present his views and evidence, the manufacturer proves to the Secretary's satisfaction that the defect or failure to comply does not create a significant risk of injury, including genetic injury, to any person, the Secretary shall issue an exemption from the requirement of notification to the manufacturer and shall notify the manufacturer in writing specifying:
(1) The electronic product or products for which the exemption has been issued; and
(2) Such conditions as the Secretary deems necessary to protect the public health and safety.
(d) Any person who contests denial of an exemption shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
42 U.S.C. 263b-263n.
(a) If any electronic product fails to comply with an applicable Federal standard or has a defect and the notification specified in § 1003.10(b) of this chapter is required to be furnished, the manufacturer of such product shall;
(1) Without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied; or
(2) Replace such product with a like or equivalent product which complies with each applicable Federal standard and which has no defect relating to the safety of its use; or
(3) Make a refund of the cost of the product to the purchaser.
(b) The manufacturer shall take the action required by this section in accordance with a plan approved by the Secretary pursuant to § 1004.6.
Every plan for bringing an electronic product into conformity with applicable Federal standards or for remedying any defect in such product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have left the place of manufacture.
(c) The specific modifications, alterations, changes, repairs, corrections, or adjustments to be made to bring the product into conformity or remedy any defect.
(d) The manner in which the operations described in paragraph (c) will be accomplished, including the procedure for obtaining access to, or possession of, the products and the location where such operations will be performed.
(e) The technical data, test results or studies demonstrating the effectiveness of the proposed remedial action.
(f) A time limit, reasonable in light of the circumstances, for completion of the operations.
(g) The system by which the manufacturer will provide reimbursement for any transportation expenses incurred in connection with having such product brought into conformity or having any defect remedied.
(h) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at his expense, will repair the electronic product involved,
(2) Of the method by which the manufacturer will obtain access to or possession of the product to make such repairs,
(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with making such repairs, and
(4) Of the manner in which such reimbursement will be effected.
(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products repaired.
Every plan for replacing an electronic product with a like or equivalent product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:
(a) Identification of the product to be replaced.
(b) A description of the replacement product in sufficient detail to support the manufacturer's contention that the replacement product is like or equivalent to the product being replaced.
(c) The approximate number of defective product units which have left the place of manufacture.
(d) The manner in which the replacement operation will be effected including the procedure for obtaining possession of the product to be replaced.
(e) A time limit, reasonable, in light of the circumstances for completion of the replacement.
(f) The steps which the manufacturer will take to insure that the defective product will not be reintroduced into commerce, until it complies with each applicable Federal standard and has no defect relating to the safety of its use.
(g) The system by which the manufacturer will provide reimbursement for any expenses for transportation of such product incurred in connection with effecting the replacement.
(h) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at its expense, will replace the electronic product involved,
(2) Of the method by which the manufacturer will obtain possession of the product and effect the replacement,
(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with effecting such replacement, and
(4) Of the manner in which such reimbursement will be made.
(i) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of electronic products replaced.
Every plan for refunding the cost of an electronic product shall be submitted to the Secretary in writing, and in addition to other relevant information which the Secretary may require, shall include:
(a) Identification of the product involved.
(b) The approximate number of defective product units which have left the place of manufacture.
(c) The manner in which the refund operation will be effected including the procedure for obtaining possession of the product for which the refund is to be made.
(d) The steps which the manufacturer will take to insure that the defective products will not be reintroduced into commerce, until it complies with each applicable Federal standard and has no defect relating to the safety of its use.
(e) A time limit, reasonable in light of the circumstances, for obtaining the product and making the refund.
(f) A statement that the manufacturer will refund the cost of such product together with the information the manufacturer has used to determine the amount of the refund.
(g) The text of the statement which the manufacturer will send to the persons specified in § 1003.10(b) of this chapter informing such persons;
(1) That the manufacturer, at his expense, will refund the cost of the electronic product plus any transportation costs,
(2) Of the amount to be refunded exclusive of transportation costs,
(3) Of the method by which the manufacturer will obtain possession of the product and make the refund.
(h) An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of refunds made.
If, after review of any plan submitted pursuant to this subchapter, the Secretary determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 1004.1 in a manner designed to encourage the public to respond to the proposal, the Secretary will send written notice of his approval of such plan to the manufacturer. Such approval may be conditioned upon such additional terms as the Secretary deems necessary to protect the public health and safety. Any person who contests denial of a plan shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.
42 U.S.C. 263d, 263h.
(a) The provisions of §§ 1005.1 through 1005.24 are applicable to electronic products which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.
(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.
As used in this part:
The term
The importation of any electronic product for which standards have been prescribed under section 358 of the Act (42 U.S.C. 263f) shall be refused admission into the United States unless there is affixed to such product a certification in the form of a label or tag in conformity with section 358(h) of the Act (42 U.S.C. 263f(h)). Merchandise refused admission shall be destroyed or exported under regulations prescribed by the Secretary of the Treasury unless a timely and adequate petition for permission to bring the product into compliance is filed and granted under §§ 1005.21 and 1005.22.
When a sample of a product to be offered for importation has been requested by the Secretary, the District Director of Customs having jurisdiction over the shipment shall, upon the arrival of the shipment, procure the sample and shall give to its owner or consignee prompt notice of the delivery or of the intention to deliver such sample to the Secretary. If the notice so requires, the owner or consignee will hold the shipment of which the sample is typical and not release such shipment until he receives notice of the results of the tests of the sample from the Secretary, stating that the product is in compliance with the requirements of the Act. The District Director of Customs will be given the results of the tests. If the Secretary notifies the District Director of Customs that the product does not meet the requirements of the Act, the District Director of Customs shall require the exportation or destruction of the shipment in accordance with customs laws.
The Department of Health and Human Services will pay for all import samples of electronic products rendered unsalable as a result of testing, or will pay the reasonable costs of repackaging such samples for sale, if the samples are found to be in compliance with the requirements of the Radiation Control for Health and Safety Act of 1968. Billing for reimbursement shall be made by the owner or consignee to the Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857. Payment for samples will not be made if the sample is found to be in violation of the Act, even though subsequently brought into compliance pursuant to terms specified in a notice of permission issued under § 1005.22.
(a) If, from an examination of the sample or otherwise, it appears that the product may be subject to a refusal of admission, the Secretary shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony unless the owner or consignee indicates his intention to bring the product into compliance. Upon timely request, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article and may be introduced orally or in writing.
(b) If the owner or consignee submits or indicates his intention to submit an application for permission to perform such action as is necessary to bring the product into compliance with the Act, such application shall include the information required by § 1005.21.
(c) If the application is not submitted at or prior to the hearing, the Secretary may allow a reasonable time for filing such application.
Application for permission to perform such action as is necessary to bring the product into compliance with the Act may be filed only by the owner, consignee, or manufacturer and, in addition to any other information which the Secretary may reasonably require, shall:
(a) Contain a detailed proposal for bringing the product into compliance with the Act;
(b) Specify the time and place where such operations will be effected and the approximate time for their completion; and
(c) Identify the bond required to be filed pursuant to § 1005.23.
(a) When permission contemplated by § 1005.21 is granted, the Secretary shall notify the applicant in writing, specifying:
(1) The procedure to be followed;
(2) The disposition of the rejected articles or portions thereof;
(3) That the operations are to be carried out under the supervision of a representative of the Department of Health and Human Services;
(4) A reasonable time limit for completing the operations; and
(5) Such other conditions as he finds necessary to maintain adequate supervision and control over the product.
(b) Upon receipt of a written request for an extension of time to complete the operations necessary to bring the product into compliance, the Secretary may grant such additional time as he deems necessary.
(c) The notice of permission may be amended upon a showing of reasonable grounds thereof and the filing of an amended application for permission with the Secretary.
(d) If ownership of a product included in a notice of permission changes before the operations specified in the notice have been completed, the original owner will remain responsible under its bond, unless the new owner has executed a superseding bond on customs Form 7601 and obtained a new notice.
(e) The Secretary will notify the District Director of Customs having jurisdiction over the shipment involved, of the determination as to whether or not the product has in fact been brought into compliance with the Act.
The bond required under section 360(b) of the Act shall be executed by the owner or consignee on the appropriate form of a customs single-entry bond, customs Form 7551 or term bond, customs Form 7553 or 7595, containing a condition for the redelivery of the shipment or any part thereof not complying with the laws and regulations governing its admission into the commerce of the United States upon demand of the District Director of Customs and containing a provision for the performance of any action necessary to bring the product into compliance with all applicable laws and regulations. The bond shall be filed with the District Director of Customs.
The costs of supervising the operations necessary to bring a product into compliance with the Act shall be paid by the owner or consignee who files an application pursuant to § 1005.21 and executes a bond under section 360(b) of the Act. Such costs shall include:
(a) Travel expenses of the supervising officer;
(b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law;
(c)
(2) The charge for the services of the analyst, which shall include administrative and laboratory support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-12/4 employee.
(3) The rate per hour equal to 266 percent of the equivalent hourly rate of regular pay of the supervising officer (GS-11/4) and the analyst (GS-12/4) is computed as follows:
(d) The minimum charge for services of supervising officers shall be not less than the charge for 1 hour and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than one-half hour.
(a) Every manufacturer of electronic products, prior to offering such product for importation into the United States, shall designate a permanent resident of the United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions, and requirements may be made for and on behalf of the manufacturer as provided in section 360(d) of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263h(d)) and this section. The agent may be an individual, a firm, or a domestic corporation. For purposes of this section, any number of manufacturers may designate the same agent.
(b) A manufacturer designating an agent must address the designation to the Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850. It must be in writing and dated; all signatures must be in ink. The designation must be made in the legal form required to make it valid and binding on the manufacturer under the laws, corporate bylaws, or other requirements governing the making of the designation by the manufacturer at the place and time where it is made, and the persons or person signing the designation shall certify that it is so made. The designation must disclose the manufacturer's full legal name and the name(s) under which the manufacturer conducts the business, if
(c) Service of any process, notice, order, requirement, or decision specified in section 360(d) of the Radiation Control for Health and Safety Act of 1968 may be made by registered or certified mail addressed to the agent with return receipt requested, or in any other manner authorized by law. In the absence of such a designation or if for any reason service on the designated agent cannot be effected, service may be made as provided in section 360(d) by posting such process, notice, order, requirement, or decision in the Office of the Director, Center for Devices and Radiological Health and publishing a notice that such service was made in the
21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n.
The standards listed in this subchapter are prescribed pursuant to section 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.
(b) The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language.
(c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not
(d) In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language.
(1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “Inc.,” or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously suppled the Director, Center for Devices and Radiological Health with sufficient information to identify the manufacturer of the product.
(2) The place and month and year of manufacture:
(i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.
(ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows:
(b) In the case of products for which it is not feasible to affix identification labeling in accordance with paragraph (a) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such identification may be provided.
(c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured.
(a)
(i) The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard, or
(ii) There is not sufficient time for the promulgation of an amendment to the standard.
(2) The issuance of the variance shall be based upon a determination that:
(i) The product utilizes an alternate means for providing radiation safety or protection equal to or greater than that provided by products meeting all requirements of the applicable standard, or
(ii) The product performs a function or is intended for a purpose which could not be performed or accomplished if required to meet the applicable standards, and suitable means for assuring radiation safety or protection are provided, or
(iii) One or more requirements of the applicable standard are not appropriate, and suitable means for assuring radiation safety or protection are provided.
(b)
(1) The application for variance shall include the following information:
(i) A description of the product and its intended use.
(ii) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.
(iii) A description of the manner in which it is proposed to deviate from the requirements of the applicable standard.
(iv) A description of the advantages to be derived from such deviation.
(v) An explanation of how alternate or suitable means of radiation protection will be provided.
(vi) The period of time it is desired that the variance be in effect, and, if appropriate, the number of units the applicant wishes to manufacture.
(vii) In the case of prototype or experimental equipment, the proposed location of each unit.
(viii) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application.
(ix) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the good laboratory practice regulations set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
(x) [Reserved]
(xi) If the electronic product is used in a clinical investigation involving human subjects, is subject to the requirements for institutional review set forth in part 56 of this chapter, and is subject to the requirements for informed consent set forth in part 50 of this chapter, the investigation shall be conducted in compliance with such requirements.
(2) The application for amendment or extension of a variance shall include the following information:
(i) The variance number and expiration date.
(ii) The amendment or extension requested and basis for the amendment or extension.
(iii) A description of the effect of the amendment or extension on protection from radiation produced by the product.
(iv) An explanation of how alternate or suitable means of protection will be provided.
(c)
(2) The Director, Center for Devices and Radiological Health, shall amend or withdraw a variance whenever the Director determines that this action is necessary to protect the public health or otherwise is justified by this subchapter. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification
(3) All applications for variances and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications will be available for public disclosure in the office of the Dockets Management Branch, except for information regarded as confidential under section 360A(e) of the act.
(d)
(1) That the product is in conformity with the applicable standard, except with respect to those characteristics covered by the variance;
(2) That the product is in conformity with the provisions of the variance; and
(3) The assigned number and effective date of the variance.
(a)
(1) The procuring agency shall prescribe procurement specifications for the product or class of products governing emissions of electronic product radiation, and the product or class shall be of a type used solely or predominantly by a department or agency of the United States.
(2) The product or class of products is intended for research, investigations, studies, demonstration, or training, or for reasons of national security.
(b)
(c)
(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.
(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.
(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.
(4) A description of the product or class of products and its intended use.
(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.
(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.
(7) An explanation of the advantages to be derived from such deviation.
(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.
(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.
(10) The name, address, and telephone number of the manufacturer or his agent.
(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.
(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.
(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.
(d)
(1) The exemption number and expiration date.
(2) The amendment or extension requested and basis for the amendment or extension.
(3) If the radiation safety specifications for the product or class of products or the product's or class of products’ use or related radiation control procedures differ from the description
(e)
(2) The Director, Center for Devices and Radiological Health, shall amend or withdraw an exemption whenever he determines that such action is necessary to protect the public health or otherwise is justified by provisions of the act or this subchapter. Such action shall become effective on the date specified in the written notice of the action sent to the applicant, except that it shall become effective immediately when the Director determines that it is necessary to prevent an imminent health hazard.
(f)
This electronic product has been exempted from Food and Drug Administration radiation safety performance standards prescribed in the Code of Federal Regulations, title 21, chapter I, subchapter J, pursuant to Exemption No.
The Director, Center for Devices and Radiological Health, may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this subchapter for an electronic product if he determines that such products are not susceptible to satisfactory testing by the procedures set forth in the standard and that the alternative test procedures assure compliance with the standard.
The performance standards prescribed in this subchapter shall not apply to any electronic product which is intended solely for export if:
(a) Such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and
(b) Such product meets all the applicable requirements of the country to which such product is intended for export.
21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381.
(a)
(b)
(2)
(3)
(4)
(5)
(6)
(c)
(2)
(3)
(i) On television receivers manufactured subsequent to January 15, 1970, measurements shall be made with all user controls adjusted so as to produce maximum x-radiation emissions from the receiver.
(ii) On television receivers manufactured subsequent to June 1, 1970, measurements shall be made with all user controls and all service controls adjusted to combinations which result in the production of maximum x-radiation emissions.
(iii) On television receivers manufactured subsequent to June 1, 1971, measurements shall be made under the conditions described in paragraph (c)(3) (ii) of this section, together with conditions identical to those which result from that component or circuit failure which maximizes x-radiation emissions.
(4)
(a)
(b)
(c)
(ii) The divergence of the exit beam from tubes designed primarily to demonstrate the effects of x radiation, with the beam blocking device in the open position, shall not exceed (Pi) steradians.
(2)
(ii) Measurements of exposure rates from tubes in enclosures from which the tubes cannot be removed without destroying the function of the tube may be made at a distance of thirty (30) centimeters from any point on the external surface of the enclosure, provided:
(
(
(3)
(ii) Measurements shall be made with the tube operated under forward and reverse polarity.
(4)
(ii) Each enclosure or tube shall have inscribed on or permanently affixed to it, tags or labels, which identify the intended polarity of the terminals and:
(
(iii) The tag or label required by this paragraph shall be located on the tube or enclosure so as to be readily visible and legible when the product is fully assembled for use.
(a)
(i) The following components of diagnostic x-ray systems:
(A) Tube housing assemblies, x-ray controls, x-ray high-voltage generators, x-ray tables, cradles, film changers, vertical cassette holders mounted in a fixed location and cassette holders with front panels, and beam-limiting devices manufactured after August 1, 1974.
(B) Fluoroscopic imaging assemblies manufactured after August 1, 1974, and before April 26, 1977.
(C) Spot-film devices and image intensifiers manufactured after April 26, 1977.
(D) Cephalometric devices manufactured after February 25, 1978.
(E) Image receptor support devices for mammographic x-ray systems manufactured after September 5, 1978.
(ii) Diagnostic x-ray systems, except computed tomography x-ray systems, incorporating one or more of such components; however, such x-ray systems shall be required to comply only with those provisions of this section and §§ 1020.31 and 1020.32 which relate to the components certified in accordance with paragraph (c) of this section and installed into the systems.
(iii) Computed tomography (CT) x-ray systems manufactured before November 29, 1984.
(iv) CT gantries manufactured after September 3, 1985.
(2) The following provisions of this section and § 1020.33 are applicable to CT x-ray systems manufactured or remanufactured on or after November 29, 1984:
(i) Section 1020.30(a);
(ii) Section 1020.30(b) “Technique factors”;
(iii) Section 1020.30(b) “CT,” “Dose,” “Scan,” “Scan time,” and “Tomogram”;
(iv) Section 1020.30 (h)(3)(vi) through (h)(3)(viii);
(v) Section 1020.30(n);
(vi) Section 1020.33 (a) and (b);
(vii) Section 1020.33(c)(1) as it affects § 1020.33(c)(2); and
(viii) Section 1020.33(c)(2).
(3) The provisions of this section and § 1020.33 in its entirety, including those provisions in paragraph (a)(2) of this section, are applicable to CT x-ray systems manufactured or remanufactured on or after September 3, 1985. The date of manufacture of the CT system is the date of manufacture of the CT gantry.
(b)
(1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this subchapter but which requires an initial determination of compatibility with the system; or
(2) A component necessary for compliance of the system with applicable provisions of this subchapter but which may be interchanged with similar compatible components without affecting the system's compliance, such as one of a set of interchangeable beam-limiting devices; or
(3) A component compatible with all x-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder.
(1) A removable device which supports and may restrain a patient above an x-ray table; or
(2) A device;
(i) Whose patient support structure is interposed between the patient and the image receptor during normal use;
(ii) Which is equipped with means for patient restraint; and
(iii) Which is capable of rotation about its long (longitudinal) axis.
(1) The useful beam; and
(2) Radiation produced when the exposure switch or timer is not activated.
(1) For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being 10 millicoulombs (or 10 mAs) or the minimum obtainable from the unit, whichever is larger;
(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; and
(3) For all other diagnostic source assemblies, the maximum-rated continuous tube current for the maximum-rated continuous tube current for the maximum-rated peak tube potential.
(1) The tube cannot be inserted in its housing in a manner that would result in noncompliance of the system with the requirements of paragraphs (k) and (m) of this section;
(2) The focal spot position will not cause noncompliance with the provisions of this section or § 1020.31 or § 1020.32;
(3) The shielding within the tube housing cannot be displaced; and
(4) Any removal and subsequent replacement of a beam-limiting device during reloading of the tube in the tube housing will not result in noncompliance of the x-ray system with the applicable field limitation and alignment requirements of §§ 1020.31 and 1020.32.
(1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliamperes-seconds (mAs);
(2) For field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses;
(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of the tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and
(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs.
(1)
(2)
(3)
(c)
(d)
(1)
(2)
(i) Reloaded or replacement tube housing assemblies that are reinstalled in or newly assembled into an existing x-ray system;
(ii) Certified accessory components that have been identified as such to the Center for Devices and Radiological Health in the report required under § 1002.10 of this chapter;
(iii) Repaired components, whether or not removed from the system and reinstalled during the course of repair, provided the original installation into the system was reported; or
(iv) Components installed temporarily in an x-ray system in place of components removed temporarily for repair, provided the temporarily installed component is identified by a tag or label bearing the following information:
This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer.
The replacement of the temporarily installed component by a component other than the component originally removed for repair shall be reported as specified in paragraph (d)(1) of this section.
(e)
(1)
(2)
(3)
(f) [Reserved]
(g)
(1) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;
(2) A statement of the maximum line current of the x-ray system based on the maximum input voltage and current characteristics of the tube housing assembly compatible with rated output voltage and rated output current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, he shall provide necessary information to allow the assembler to determine the maximum line current for the particular tube housing assembly(ies);
(3) A statement of the technique factors that constitute the maximum line current condition described in paragraph (g)(2) of this section.
(h)
(1)
(i) Adequate instructions concerning any radiological safety procedures and precautions which may be necessary because of unique features of the equipment; and
(ii) A schedule of the maintenance necessary to keep the equipment in compliance with this section and §§ 1020.31, 1020.32, and 1020.33.
(2)
(i) Statements of the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the tube housing assembly manufacturer states compatibility, the minimum filtration permanently in the useful beam expressed as millimeters of aluminum equivalent, and the peak tube potential at which the aluminum equivalent was obtained;
(ii) Cooling curves for the anode and tube housing; and
(iii)
(3)
(i) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;
(ii) A statement of the maximum line current of the x-ray system based on the maximum input voltage and output current characteristics of the tube housing assembly compatible with rated output voltage and rated current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, the manufacturer shall provide necessary information to allow the purchaser to determine the maximum line current for his particular tube housing assembly(ies);
(iii) A statement of the technique factors that constitute the maximum line current condition described in paragraph (h)(3)(ii) of this section;
(iv) In the case of battery-powered generators, a specification of the minimum state of charge necessary for proper operation;
(v) Generator rating and duty cycle;
(vi) A statement of the maximum deviation from the preindication given by labeled technique factor control settings or indicators during any radiographic or CT exposure where the equipment is connected to a power supply as described in accordance with this paragraph. In the case of fixed technique factors, the maximum deviation from the nominal fixed value of each factor shall be stated;
(vii) A statement of the maximum deviation from the continuous indication of x-ray tube potential and current during any fluoroscopic exposure when the equipment is connected to a power supply as described in accordance with this paragraph; and
(viii) A statement describing the measurement criteria for all technique factors used in paragraphs (h)(3)(iii), (h)(3)(vi), and (h)(3)(vii) of this section; for example, the beginning and endpoints of exposure time measured with respect to a certain percentage of the voltage waveform.
(4)
(i) Leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the beam-limiting device manufacturer states compatibility; and
(ii) A statement including the minimum aluminum equivalent of that part of the device through which the useful beam passes and including the x-ray tube potential at which the aluminum equivalent was obtained. When two or more filters are provided as part of the device, the statement shall include the aluminum equivalent of each filter.
(i) [Reserved]
(j)
“Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.”
(k)
(l)
(m)
(2)
(n)
(o)
(p) [Reserved]
(q)
(2) The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system, provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this section or of § 1020.31, § 1020.32, or § 1020.33. The owner who causes such modification need not submit the reports required by subpart B of part 1002 of this chapter, provided the owner records the date and the details of the modification, and provided the modification of the x-ray system does not result in a failure to comply with § 1020.31, § 1020.32, or § 1020.33.
The provisions of this section apply to equipment for the recording of images, except equipment involving use of an image intensifier or computed tomography x-ray systems manufactured on or after November 28, 1984.
(a)
(2)
(i) Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.
(ii) During serial radiography, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.
(3)
(i) Indication shall be made on the control panel when this mode of operation is selected;
(ii) When the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment shall be equal to or less than 1/60 second or a time interval required to deliver 5 milliamperes-seconds (mAs), whichever is greater;
(iii) Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than
(iv) A visible signal shall indicate when an exposure has been terminated at the limits described in paragraph (a)(3)(iii) of this section, and manual resetting shall be required before further automatically timed exposures can be made.
(4)
(b)
(1)
(2)
(c)
(1)
(2)
(3)
(d)
(1)
(2)
(ii) When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than 160 lux (15 footcandles) at 100 centimeters or at the maximum SID, whichever is less. The average illuminance shall be based upon measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.
(iii) The edge of the light field at 100 centimeters or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I
(e)
(1) Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2 percent of the SID, and to indicate the SID to within 2 percent;
(2) The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;
(3) Indication of field size dimensions and SID's shall be specified in centimeters and/or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within 2 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and
(4) Compliance measurements will be made at discrete SID's and image receptor dimensions in common clinical use (such as SID's of 100, 150, and 200 centimeters and/or 36, 40, 48, and 72 inches and nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 centimeters and/or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches) or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.
(f)
(i) If the minimum source-to-skin distance (SSD) is 18 centimeters or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than 7 centimeters; and
(ii) If the minimum SSD is less than 18 centimeters, the x-ray field at the minimum SSD shall be containable in
(2)
(3)
(ii) Each image receptor support device intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.
(4)
(i) A system which performs in accordance with paragraphs (d) and (e) of this section; or when alignment means are also provided, may be met with either;
(ii) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
(iii) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.
(g)
(1)
(i) Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3 percent of the SID; or
(ii) The sum of the length and width differences as stated in paragraph (g)(1)(i) of this section without regard to sign exceeds 4 percent of the SID.
(iii) The beam limiting device is at an SID for which PBL is not designed for sizing.
(2)
(i) The image receptor is inserted into a permanently mounted cassette holder;
(ii) The image receptor length and width are less than 50 centimeters;
(iii) The x-ray beam axis is within
(iv) The x-ray beam axis is perpendicular to the plane of the image receptor to within
(v) Neither tomographic nor stereoscopic radiography is being performed.
(3)
(4)
(5)
The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.
(h)
(1) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.
(2) Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3 percent of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4 percent of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(3) The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID.
(4) Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:
(i) For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest
(ii) For spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 centimeters by 5 centimeters.
(5) A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:
(i)
(i) Eighteen centimeters if operable above 50 kVp; or
(ii) Ten centimeters if not operable above 50 kVp.
(2) Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than 30 centimeters.
(j)
(k)
(l)
(1) 8.6×10
(2) 2.58×10
(m)
(1) At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge.
(2) The x-ray tube shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in paragraph (m)(1) of this section.
(3) The transmission of the useful beam through the primary protective barrier shall be limited such that the exposure 5 centimeters from any accessible surface beyond the plane of the primary protective barrier does not exceed 2.58X10
(4) Compliance for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at the maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters. The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the
The provisions of this section apply to equipment for fluoroscopy and for the recording of images through an image intensifier except computed tomography x-ray systems manufactured on or after November 29, 1984.
(a)
(2)
(b)
(ii) For equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with paragraph (b)(1)(i) of this section shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(2)
(ii) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.
(iii) For equipment manufactured after February 25, 1978, when the angle
(iv) Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or the capability of a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 square centimeters shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 centimeters by 5 centimeters.
(3) If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:
(c)
(d)
(1)
(i) During recording of fluoroscopic images, or
(ii) When an optional high-level control is provided. When so provided, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29x10
(2)
(i) During recording of fluoroscopic images, or
(ii) When an optional high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.
(3)
(i) During recording of fluoroscopic images, or
(ii) When the mode or modes have an optional high-level control, in which case that mode or modes shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 1.29x10
(4)
(i) If the source is below the x-ray table, the exposure rate shall be measured at 1 centimeter above the tabletop or cradle.
(ii) If the source is above the x-ray table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
(iii) In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the imaging assembly.
(iv) In a lateral type of fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.
(5)
(e)
(1) Fluoroscopic equipment operable at any combination of tube potential and current that results in an exposure rate greater than 1.29x10
(2) Fluoroscopic equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 2.58x10
(i) During the recording of images from an x-ray image-intensifier tube using photographic film or a video camera when the x-ray source is operated in a pulsed mode.
(ii) When an optional high-level control is activated. When the high-level control is activated, the equipment shall not be operable at any combination of tube potential and current that will result in an exposure rate in excess of 5.16x10
(3)
(i) If the source is below the x-ray table, the exposure rate shall be measured at 1 centimeter above the tabletop or cradle.
(ii) If the source is above the x-ray table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
(iii) In a C-arm type of fluoroscope, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly.
(iv) In a lateral type of fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.
(4)
(f)
(g)
(h)
(i)
(a)
(2) The provisions of paragraphs (b), (c)(1), and (c)(2) are applicable to CT x-ray systems manufactured or remanufactured on or after November 29, 1984.
(b)
(1)
(2)
(3)
(4)
(5) [Reserved]
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(c)
(1)
(2)
(i) The CTDI at the following locations in the dosimetry phantom:
(
(
(
(ii) The CTDI in the center location of the dosimetry phantom for each selectable CT condition of operation that varies either the rate or duration of x-ray exposure. This CTDI shall be presented as a value that is normalized to the CTDI in the center location of the dosimetry phantom from paragraph (c)(2)(i) of this section, with the CTDI of paragraph (c)(2)(i) of this section having a value of one. As each individual CT condition of operation is changed, all other independent CT conditions of operation shall be maintained at the typical values described in paragraph (c)(2)(i) of this section. These data shall encompass the range of each CT condition of operation stated by the manufacturer as appropriate for CT of the head or body. When more than three selections of a CT condition of operation are available, the normalized CTDI shall be provided, at least, for the minimum, maximum, and mid-range value of the CT condition of operation.
(iii) The CTDI at the location coincident with the maximum CTDI at 1 centimeter interior to the surface of the dosimetry phantom for each selectable peak tube potential. When more than three selections of peak tube potential are available, the normalized CTDI shall be provided, at least, for the minimum, maximum, and a typical value of peak tube potential. The CTDI shall
(iv) The dose profile in the center location of the dosimetry phantom for each selectable nominal tomographic section thickness. When more than three selections of nominal tomographic section thicknesses are available, the information shall be provided, at least, for the minimum, maximum, and midrange value of nominal tomographic section thickness. The dose profile shall be presented on the same graph and to the same scale as the corresponding sensitivity profile required by paragraph (c)(3)(iv) of this section.
(v) A statement of the maximum deviation from the values given in the information provided according to paragraph (c) (2) (i), (ii), (iii), and (iv) of this section. Deviation of actual values may not exceed these limits.
(3)
(i) A statement of the noise.
(ii) A graphical presentation of the modulation transfer function for the same image processing and display mode as that used in the statement of the noise.
(iii) A statement of the nominal tomographic section thickness(es).
(iv) A graphical presentation of the sensitivity profile, at the location corresponding to the center location of the dosimetry phantom, for each selectable nominal tomographic section thickness for which the dose profile is given according to paragraph (c)(2)(iv) of this section.
(v) A description of the phantom or device and test protocol or procedure used to determine the specifications and a statement of the maximum deviation from the specifications provided in accordance with paragraphs (c)(3) (i), (ii), (iii), and (iv) of this section. Deviation of actual values may not exceed these limits.
(d)
(1) A phantom(s) capable of providing an indication of contrast scale, noise, nominal tomographic section thickness, the spatial resolution capability of the system for low and high contrast objects, and measuring the mean CT number of water or a reference material.
(2) Instructions on the use of the phantom(s) including a schedule of testing appropriate for the system, allowable variations for the indicated parameters, and a method to store as records, quality assurance data.
(3) Representative images obtained with the phantom(s) using the same processing mode and CT conditions of operation as in paragraph (c)(3) of this section for a properly functioning system of the same model. The representative images shall be of two forms as follows:
(i) Photographic copies of the images obtained from the image display device.
(ii) Images stored in digital form on a storage medium compatible with the CT x-ray system. The CT x-ray system shall be provided with the means to display these images on the image display device.
(e) [Reserved]
(f)
(2)
(ii) Means shall be provided so that the operator can terminate the x-ray exposure at any time during a scan, or series of scans under x-ray system control, of greater than one-half second duration. Termination of the x-ray exposure shall necessitate resetting of the CT conditions of operation prior to the initiation of another scan.
(g)
(2) For any multiple tomogram system, means shall be provided to permit visual determination of the location of a reference plane. The relationship of the reference plane to the planes of the tomograms shall be provided to the user in addition to other information provided according to § 1020.30(h). This reference plane can be offset from the location of the tomographic planes.
(3) The distance between the indicated location of the tomographic plane or reference plane and its actual location may not exceed 5 millimeters.
(4) For any offset alignment system, the manufacturer shall provide specific instructions with respect to the use of this system for patient positioning, in addition to other information provided according to § 1020.30(h).
(5) If a mechanism using a light source is used to satisfy the requirements of paragraphs (g) (1) and (2) of this section, the light source shall allow visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to 500 lux.
(h)
(2) For systems that allow high voltage to be applied to the x-ray tube continuously and that control the emission of x rays with a shutter, the radiation emitted may not exceed 100 milliroentgens (2.58×10
(i)
(j)
(2) The manufacturer shall provide specific instructions concerning the use of the method provided for calculation of CT number mean and standard deviation in addition to other information provided according to § 1020.30(h).
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(c)
(ii) Compliance with the exposure limit in paragraph (c)(1)(i) of this section shall be determined by measurements averaged over a cross-sectional area of ten square centimeters with no linear dimension greater than 5 centimeters, with the cabinet x-ray system operated at those combinations of x-ray tube potential, current, beam orientation, and conditions of scatter radiation which produce the maximum x-ray exposure at the external surface, and with the door(s) and access panel(s) fully closed as well as fixed at any other position(s) which will allow the generation of x radiation.
(2)
(3)
(ii) The insertion of any part of the human body through any aperture shall not be possible.
(4)
(ii) Each access panel shall have at least one safety interlock.
(iii) Following interruption of x-ray generation by the functioning of any safety interlock, use of a control provided in accordance with paragraph (c)(6)(ii) of this section shall be necessary for resumption of x-ray generation.
(iv) Failure of any single component of the cabinet x-ray system shall not cause failure of more than one required safety interlock.
(5)
(6)
(i) A key-actuated control to insure that x-ray generation is not possible with the key removed.
(ii) A control or controls to initiate and terminate the generation of x-rays other than by functioning of a safety interlock or the main power control.
(iii) Two independent means which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second, in which case the indicators shall be activated for one-half second, and which are discernible from any point at which initiation of x-ray generation is possible. Failure of a single component of the cabinet x-ray system shall not cause failure of both indicators to perform their intended function. One, but not both, of the indicators required by this subdivision may be a milliammeter labeled to indicate x-ray tube current. All other indicators shall be legibly labeled “X-RAY ON”.
(iv) Additional means other than milliammeters which indicate when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators shall be activated for one-half second, as needed to insure that at least one indicator is visible from each door, access panel, and port, and is legibly labeled “X-RAY ON”.
(7)
(i) A control within the cabinet for preventing and terminating x-ray generation, which cannot be reset, overridden or bypassed from the outside of the cabinet.
(ii) No means by which x-ray generation can be initiated from within the cabinet.
(iii) Audible and visible warning signals within the cabinet which are actuated for at least 10 seconds immediately prior to the first initiation of x-ray generation after closing any door designed to admit humans. Failure of any single component of the cabinet x-ray system shall not cause failure of both the audible and visible warning signals.
(iv) A visible warning signal within the cabinet which remains actuated when and only when x-rays are being generated, unless the x-ray generation period is less than one-half second in which case the indicators shall be activated for one-half second.
(v) Signs indicating the meaning of the warning signals provided pursuant to paragraphs (c)(7) (iii) and (iv) of this section and containing instructions for the use of the control provided pursuant to paragraph (c)(7)(i) of this section. These signs shall be legible, accessible to view, and illuminated when the main power control is in the “on” position.
(8)
(ii) There shall be permanently affixed or inscribed on the cabinet x-ray system adjacent to each port a clearly legible and visible label bearing the statement:
(9)
(ii) Manufacturers of cabinet x-ray systems which are intended to be assembled or installed by the purchaser shall provide instructions for assembly, installation, adjustment and testing of the cabinet x-ray system adequate to assure that the system is in compliance with applicable provisions of this section when assembled, installed, adjusted and tested as directed.
(10)
(i) During an exposure or preset succession of exposures of one-half second or greater duration, the means provided shall enable the operator to terminate the exposure or preset succession of exposures at any time.
(ii) During an exposure or preset succession of exposures of less than one-half second duration, the means provided may allow completion of the exposure in progress but shall enable the operator to prevent additional exposures.
(d)
21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n.
(a)
(b)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(c)
(2)
(ii) Failure of any single mechanical or electrical component of the microwave oven shall not cause all safety interlocks to be inoperative.
(iii) Service adjustments or service procedures on the microwave oven shall not cause the safety interlocks to become inoperative or the microwave radiation emission to exceed the power density limits of this section as a result of such service adjustments or procedures.
(iv) Microwave radiation emission in excess of the limits specified in paragraph (c)(1) of this section shall not be
(v) One (the primary) required safety interlock shall prevent microwave radiation emission in excess of the requirement of paragraph (c)(1) of this section; the other (secondary) required safety interlock shall prevent microwave radiation emission in excess of 5 milliwatts per square centimeter at any point 5 centimeters or more from the external surface of the oven. The two required safety interlocks shall be designated as primary or secondary in the service instructions for the oven.
(vi) A means of monitoring one or both of the required safety interlocks shall be provided which shall cause the oven to become inoperable and remain so until repaired if the required safety interlock(s) should fail to perform required functions as specified in this section. Interlock failures shall not disrupt the monitoring function.
(3)
(ii) Microwave ovens shall be in compliance with the power density limits if the maximum reading obtained at the location of greatest microwave radiation emission, taking into account all measurement errors and uncertainties, does not exceed the limit specified in paragraph (c)(1) of this section, when the emission is measured through at least one stirrer cycle. As provided in § 1010.13 of this chapter, a manufacturer may request alternative test procedures if, as a result of the stirrer characteristics of a microwave oven, such oven is not susceptible to testing by the procedures described in this paragraph.
(iii) Measurements shall be made with the microwave oven operating at its maximum output and containing a load of 275
(iv) Measurements shall be made with the door fully closed as well as with the door fixed in any other position which allows the oven to operate.
(4)
(i) Occupy a separate section and are an integral part of the regularly supplied users’ manual and cookbook, if supplied separately, and are located so as to elicit the attention of the reader.
(ii) Are as legible and durable as other instructions with the title emphasized to elicit the attention of the reader by such means as bold-faced type, contrasting color, a heavy-lined border, or by similar means.
(iii) Contain the following wording:
(
(
(
(
(iv) Include additional radiation safety precautions or instructions which
(5)
(i) Occupy a separate section and are an integral part of the regularly supplied service manual and are located so as to elicit the attention of the reader.
(ii) Are as legible and durable as other instructions with the title emphasized so as to elicit the attention of the reader by such means as bold-faced type, contrasting color, a heavy-lined border, or by similar means.
(iii) Contain the following wording:
(
(
(
(
(
(iv) Include additional radiation safety precautions or instructions which may be necessary for particular oven designs or models, as determined by the Director, Center for Devices and Radiological Health or the manufacturer.
(6)
(i) A label, permanently attached to or inscribed on the oven, which shall be legible and readily viewable during normal oven use, and which shall have the title emphasized and be so located as to elicit the attention of the user. The label shall bear the following warning statement:
DO NOT Attempt to Operate This Oven With:
(
(
(
(ii) A label, permanently attached to or inscribed on the external surface of the oven, which shall be legible and readily viewable during servicing, and which shall have the word “CAUTION” emphasized and be so located as to elicit the attention of service personnel. The label shall bear the following warning statement:
(iii) The labels provided in accordance with paragraphs (c)(6)(i) and (ii) of this section shall bear only the statements specified in that paragraph, except for additional radiation safety warnings or instructions which may be necessary for particular oven designs or models, as determined by the Director, Center for Devices and Radiological Health or the manufacturer.
(iv) Upon application by a manufacturer, the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant an exemption from one or more of the statements (radiation safety warnings) specified in paragraph (c)(6)(i) of this section. Such exemption shall be based upon a determination by the Director
(
(
(
(
21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n.
(a)
(1) Such a laser product is either sold to a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use as a component (or replacement) in such electronic product, provided that such laser product:
(i) Is accompanied by a general warning notice that adequate instructions for the safe installation of the laser product are provided in servicing information available from the complete laser product manufacturer under paragraph (h)(2)(ii) of this section, and should be followed,
(ii) Is labeled with a statement that it is designated for use solely as a component of such electronic product and therefore does not comply with the appropriate requirements of this section and § 1040.11 for complete laser products, and
(iii) Is not a removable laser system as described in paragraph (c)(2) of this section; and
(3) The manufacturer of such a laser product, if manufactured after August 20, 1986:
(i) Registers, and provides a listing by type of such laser products manufactured that includes the product name, model number and laser medium or emitted wavelength(s), and the name and address of the manufacturer. The manufacturer must submit the registration and listing to the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, 2094 Gaither Rd., Rockville, MD 20850.
(ii) Maintains and allows access to any sales, shipping, or distribution records that identify the purchaser of such a laser product by name and address, the product by type, the number of units sold, and the date of sale (shipment). These records shall be maintained and made available as specified in § 1002.31.
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(28)
(29)
(30)
(31)
(32)
(33)
(34)
(35)
(36)
(37)
(38)
(39)
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.
(40)
(41)
(42)
(c)
(2)
(d)
(1) The factors
(2) The variable
(1)
(2)
(3)
(4)
(i) The Class I accessible emission limits for radiant energy within any range of emission duration specified in table I of this paragraph, and
(ii) The Class I accessible emission limits for integrated radiance within any range of emission duration specified in table I of this paragraph.
(e)
(2)
(i) Under those conditions and procedures which maximize the accessible emission levels, including start-up, stabilized emission, and shut-down of the laser product; and
(ii) With all controls and adjustments listed in the operation, maintenance, and service instructions adjusted in combination to result in the maximum accessible emission level of radiation; and
(iii) At points in space to which human access is possible in the product configuration which is necessary to determine compliance with each requirement, e.g., if operation may require removal of portions of the protective housing and defeat of safety interlocks, measurements shall be made at points accessible in that product configuration; and
(iv) With the measuring instrument detector so positioned and so oriented with respect to the laser product as to result in the maximum detection of radiation by the instrument; and
(v) For a laser product other than a laser system, with the laser coupled to that type of laser energy source which is specified as compatible by the laser product manufacturer and which produces the maximum emission level of accessible radiation from that product.
(3)
(i) For laser products intended to be used in a locale where the emitted laser radiation is unlikely to be viewed with optical instruments, the radiant power (W) or radiant energy (J) detectable through a circular aperture stop having a diameter of 7 millimeters and within a circular solid angle of acceptance of 1 X 10
(ii) The irradiance (W cm
(iii) The radiance (W cm
(f)
(2)
(ii) Each required safety interlock, unless defeated, shall prevent such human access to laser and collateral radiation upon removal or displacement of such portion of the protective housing
(iii) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing shall be provided, if failure of a single interlock would allow;
(
(
(iv) Laser products that incorporate safety interlocks designed to allow safety interlock defeat shall incorporate a means of visual or aural indication of interlock defeat. During interlock defeat, such indication shall be visible or audible whenever the laser product is energized, with and without the associated portion of the protective housing removed or displaced.
(v) Replacement of a removed or displaced portion of the protective housing shall not be possible while required safety interlocks are defeated.
(3)
(4)
(5)
(ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emission indicator which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow appropriate action to avoid exposure to the laser radiation.
(iii) For laser systems manufactured on or before August 20, 1986, if the laser and laser energy source are housed separately and can be operated at a separation distance of greater than 2 meters, both laser and laser energy source shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section. For laser systems manufactured after August 20, 1986, each separately housed laser and operation control of a laser system that regulates the laser or collateral radiation emitted by a product during operation shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section, if the laser or operation control can be operated at a separation distance greater than 2 meters from
(iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of this section shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiation.
(v) Emission indicators required by paragraph (f)(5) (i) or (ii) of this section shall be located so that viewing does not require human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI.
(6)
(ii) If the configuration, design, or function of the laser product would make unnecessary compliance with the requirement in paragraph (f)(6)(i) of this section, the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, may, upon written application by the manufacturer, approve alternate means to accomplish the radiation protection provided by the beam attenuator.
(7)
(8)
(i) To prevent access by the human eye to laser and collateral radiation in excess of the accessible emission limits of Class I and table VI whenever the shutter is opened or the attenuator varied.
(ii) To preclude, upon failure of such means as required in paragraph (f)(8)(i) of this section, opening the shutter or varying the attenuator when access by the human eye is possible to laser or collateral radiation in excess of the accessible emission limits of Class I and table VI.
(9)
(i) The accessible emission limits of the class of the product, or
(ii) The accessible emission limits of the class of the scanned laser radiation if the product is Class IIIb or IV and the accessible emission limits of Class IIIa would be exceeded solely as result of such failure.
(10)
(g)
(1)
(ii) Each Class II laser product shall have affixed a label bearing the warning logotype A (figure 1 in this paragraph) and including the following wording:
(2)
(ii) Each Class IIIa laser product with an irradiance greater than 2.5×10
(iii) Each Class IIIb laser product shall have affixed a label bearing the warning logotype B (figure 2 of paragraph (g)(2)(ii) of this section) and including the following wording:
(3)
(4)
(5)
(i) “AVOID EXPOSURE—Laser radiation is emitted from this aperture,” if the radiation emitted through such aperture is laser radiation.
(ii) “AVOID EXPOSURE—Hazardous electromagnetic radiation is emitted from this aperture,” if the radiation emitted through such aperture is collateral radiation described in table VI, item 1.
(iii) “AVOID EXPOSURE—Hazardous x-rays are emitted from this aperture,” if the radiation emitted through such aperture is collateral radiation described in table VI, item 2.
(6)
(i) “CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM.” for Class II accessible laser radiation.
(ii) “CAUTION—Laser radiation when open. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.” for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5×10
(iii) “DANGER—Laser radiation when open. AVOID DIRECT EYE EXPOSURE.” for Class IIIa accessible laser radiation with an irradiance greater than 2.5×10
(iv) “DANGER—Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM.” for Class IIIb accessible laser radiation.
(v) “DANGER—Laser radiation when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.” for Class IV accessible laser radiation.
(vi) “CAUTION—Hazardous electromagnetic radiation when open.” for collateral radiation in excess of the accessible emission limits in table VI, item 1 of paragraph (d) of this section.
(vii) “CAUTION—Hazardous x-rays when open.” for collateral radiation in excess of the accessible emission limits in table VI, item 2 of paragraph (d) of this section.
(7)
(i) “CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM.” for Class II accessible laser radiation.
(ii) “CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS.” for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5×10
(iii) “DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EYE EXPOSURE.” for Class IIIa accessible laser radiation when an irradiance greater than 2.5×10
(iv) “DANGER—Laser radiation when open and interlock defeated. AVOID DIRECT EXPOSURE TO
(v) “DANGER—Laser radiation when open and interlock defeated. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.” for Clas IV accessible laser radiation.
(vi) “CAUTION—Hazardous electromagnetic radiation when open and interlock defeated.” for collateral radiation in excess of the accessible emission limits in table VI. item 1 of paragraph (d) of this section.
(vii) “CAUTION—Hazardous x-rays when open and interlock defeated.” for collateral radiation in excess of the accesible emission limits in table VI. item 2 of paragraph (d) of this section.
(8)
(i) Invisible radiation, the word “invisible” shall appropriately precede the word “radiation”; or
(ii) Visible and invisible radiation, the words “visible and invisible” or “visible and/or invisible” shall appropriately precede the word “radiation.”
(iii) Visible laser radiation only, the phrase “laser light” may replace the phrase “laser radiation.”
(9)
(10)
(h)
(i) Adequate instructions for assembly, operation, and maintenance, including clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11.
(ii) A statement of the magnitude, in appropriate units, of the pulse durations(s), maximum radiant power and, where applicable, the maximum radiant energy per pulse of the accessible laser radiation detectable in each direction in excess of the accessible emission limits in table I of paragraph (d) of this section determined under paragraph (e) of this section.
(iii) Legible reproductions (color optional) of all labels and hazard warnings required by paragraph (g) of this section and § 1040.11 to be affixed to the laser product or provided with the laser product, including the information required for positions 1, 2, and 3 of the applicable logotype (figure 1 of paragraph (g)(1)(ii) or figure 2 or paragraph (g)(2)(ii) of this section). The corresponding position of each label affixed to the product shall be indicated or, if provided with the product, a statement that such labels could not be affixed to the product but were supplied with the product and a statement of the form and manner in which they were supplied shall be provided.
(iv) A listing of all controls, adjustments, and procedures for operation and maintenance, including the warning “Caution—use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.”
(v) In the case of laser products other than laser systems, a statment of the
(vi) In the case of laser products classified with a 7 millimeter diameter aperture stop as provided in paragraph (e)(3)(i) of this section, if the use of a 50 millimeter diameter aperture stop would result in a higher clsssification of the product, the following warning shall be included in the user information: “CAUTION—The use of optical instruments with this product will increase eye hazard.”
(2)
(i) In all catalogs, specification sheets, and descriptive brochures pertaining to each laser product, a legible reproduction (color optional) of the class designation and warning required by paragraph (g) of this section to be affixed to that product, including the information required for positions 1, 2, and 3 of the applicable logotype (figure 1 of paragraph (g)(1)(ii) or figure 2 of paragraph (g)(2)(ii) of this section).
(ii) To servicing dealers and distributors and to others upon request at a cost not to exceed the cost of preparation and distribution, adequate instructions for service adjustments and service procedures for each laser product model, including clear warnings and precautions to be taken to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and § 1040.11; and in all such service instructions, a listing of those controls and procedures that could be utilized by persons other than the manufacturers or the manufacturer's agents to increase accessible emission levels of radiation and a clear description of the location of displaceable portions of the protective housing that could allow human access to laser or collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section. The instructions shall include protective procedures for service personnel to avoid exposure to levels of laser and collateral radiation known to be hazardous for each procedure or sequence of procedures to be accomplished, and legible reproductions (color optional) of required labels and hazard warnings.
(i)
(a)
(1) Incorporate in each Class III or IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body. Such means may have an error in measurement of no more than 20 percent when calibrated in accordance with paragraph (a)(2) of this section. Indication of the measurement shall be in International System Units. The requirements of this paragraph do not apply to any laser radiation that is all of the following:
(i) Of a level less than the accessible limits of Class IIIa; and
(ii) Used for relative positioning of the human body; and
(iii) Not used for irradiation of the human eye for ophthalmic purposes.
(2) Supply with each Class III or IV medical laser product instructions specifying a procedure and schedule for
(3) Affix to each medical laser product, in close proximity to each aperture through which is emitted accessible laser radiation in excess of the accessible emission limits of Class I, a label bearing the wording: “Laser aperture.”
(b)
(c)
(a)
(i) Any sunlamp product.
(ii) Any ultraviolet lamp intended for use in any sunlamp product.
(2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before September 8, 1986, are subject to the provisions of this section as published in the
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(c)
(2)
(ii) The maximum timer interval(s) may not exceed the manufacturer's recommended maximum exposure time(s) that is indicated on the label required by paragraph (d)(1)(iv) of this section.
(iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product.
(iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated.
(v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset time interval.
(3)
(4)
(ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 200 nanometers 320 nanometers and an value of 0.01 over the wavelength range of greater than 320 nanometers through 400 nanometers, and shall be sufficient over the wavelength greater than 400 nanometers to enable the user to see clearly enough to reset the timer.
(5)
(d)
(1)
(i) A warning statement with the words “DANGER—Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.”
(ii) Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified both in meters and in feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position.
(iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure.
(iv) A recommended exposure schedule including duration and spacing of
(v) A statement of the time it may take before the expected results appear.
(vi) Designation of the ultraviolet lamp type to be used in the product.
(2)
(i) The words “Sunlamp—DANGER—Ultraviolet radiation. Follow instructions.”
(ii) The model identification.
(iii) The words “Use ONLY in fixture equipped with a timer.”
(3)
(ii) Any label prescribed in this paragraph for ultraviolet lamps shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view.
(iii) If the size, configuration, design, or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, or would render the required label unnecessary, the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, on the Center's own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s), alernate wording for such label(s), or deletion, as applicable.
(iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by §§ 1010.2(b) and 1010.3(a), the manfacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. The name of the manufacturer and month and year of manufacture affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp. The label or tag affixed or inscribed on the lamp packaging may provide either the month and year of manufacture without abbreviation, or information to allow the date to be readily decoded.
(v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional statements are not false or misleading in any particular; e.g., if they do not diminish the impact of the required statements; and are not prohibited by this chapter.
(e)
(1)
(i) A reproduction of the label(s) required in paragraph (d)(1) of this section prominently displayed at the beginning of the instructions.
(ii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided.
(iii) Instructions for the proper operation of the product including the function, use, and setting of the timer and other controls, and the use of protective eyewear.
(iv) Instructions for determining the correct exposure time and schedule for persons according to skin type.
(v) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including
(2)
(i) A reproduction of the label(s) required in paragraphs (d)(1)(i) and (2) of this section, prominently displayed at the beginning of the instructions.
(ii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury.
(iii) A clear identification by brand and model designation of all lamp models for which replacement lamps are promoted, if applicable.
(f)
(a)
(b)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(c)
(i) Meet the requirements of either paragraph (d) or paragraph (e) of this section; and
(ii) Be permanently labeled or marked in such a manner that the name of the manufacturer and the month and year of manufacture of the lamp can be determined on an intact lamp and after the outer envelope of
(2) In lieu of permanently affixing or inscribing tags or labels on the product as required by §§ 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of any high-intensity mercury vapor discharge lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the applicable lamp.
(d)
(ii) Each self-extinguishing lamp manufactured after September 7, 1981, shall cease operation within a cumulative operating time not to exceed 15 minutes following breakage or removal of at least 3 square centimeters of contiguous surface of the outer envelope.
(2)
(3)
(i) The letter “T”; and
(ii) The words “This lamp should self-extinguish within 15 minutes after the outer envelope is broken or punctured. If such damage occurs, TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous shortwave ultraviolet radiation.”
(e)
(2)
(i) The letter “R”; and
(ii) The words “WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available.”
(3)
(f)
(1) Lamp voltage, current, and orientation shall be those indicated or recommended by the manufacturer for operation of the intact lamp.
(2) The lamp shall be operated on a reference ballast.
(3) The lamp shall be started in air that has a temperature of 25
(4) If any test is performed in an enclosure, the enclosure shall be not less than 0.227 cubic meter (8 cubic feet).
(5) Any lamp designed to be operated only in a specific fixture or luminaire that the lamp manufacturer supplies or specifies shall be tested in that fixture or luminaire. Any other lamp shall be tested with no reflector or other surrounding material.
21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n.
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(i) Any device intended to generate and emit ultrasonic radiation for therapeutic purposes at ultrasonic frequencies above 16 kilohertz (kHz); or
(ii) Any generator or applicator designed or specifically designated for use in a device as specified in paragraph (b)(25)(i) of this section.
(26)
(c)
(1)
(ii)
(2)
(3)
(4)
(5)
(d)
(1)
(2)
(3)
(ii) Generators employing amplitude-modulated waveforms shall also bear a label that provides the following information: Pulse duration and pulse repetition rate (unless there are operation controls for varying these quantities), an illustration of the amplitude-modulated waveform, and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. (If this ratio is a function of any operation control setting, then the range of the ratio shall be specified, and the waveform illustration shall be provided for the maximum value of this ratio.)
(4)
(i) The brand name, model designation, and unique serial number or other unique identification so the applicator is individually identifiable;
(ii) A designation of the generator(s) for which the applicator is intended; and
(iii) The ultrasonic frequency, effective radiating area, maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and for a focusing applicator the focal length and focal area.
(5)
(e)
(2)
(i) For all possible combinations of adjustments of the controls listed in the operation instructions.
(ii) With the ultrasonic radiation emitted into the equivalent of an infinite medium of distilled, degassed water at 30 °C for measurements concerning the ultrasonic radiation.
(iii) With line voltage variations in the range of
(3)
(f)
(2)
(i) Adequate instructions concerning assembly, operation, safe use, any safety procedures and precautions that may be necessary regarding the use of ultrasonic radiation, and a schedule of maintenance necessary to keep the equipment in compliance with this section. The operation instructions shall include a discussion of all operation controls, and shall describe the effect of each control.
(ii) Adequate description of the spatial distribution of the ultrasonic radiation field and the orientation of the field with respect to the applicator. This will include a textual discussion with diagrams, plots, or photographs representative of the beam pattern. If there is more than one ultrasonic transducer in an applicator and their positions are not fixed relative of each other, then the description must specify the spatial distribution of the ultrasonic radiation field emitted by each ultrasonic transducer and present adequate examples of the combination field of the ultrasonic tranducers with regard to safe use. The description of the ultrasonic radiation field shall state that such description applies under conditions specified in paragraph (e)(2)(ii) of this section.
(iii) Adequate description, as appropriate to the product, of the uncertainties in magnitude expressed in terms of percentage error, of the ultrasonic frequency effective radiating area, and, where applicable, the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity, pulse duration, pulse repetition rate, focal area, and focal length. The errors in indications specified in paragraphs (c)(1) and (c)(2) of this section shall be stated in the instruction manual.
(iv) A listing of controls, adjustments, and procedures for operation and maintenance, including the warning “Caution—use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.”