The purpose of the regulations contained in this part 84 is:

(a) To establish procedures and prescribe requirements which must be met in filing applications for approval by the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators;

(b) To establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part;

(c) To provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and

(d) To specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres.

As used in this part—

(a) Applicant means an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator.

(b) Approval means a certificate or formal document issued by the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this part, and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval.

(c) Approved means conforming to the minimum requirements of this part.

(d) Auxiliary equipment means a self-contained breathing apparatus, the use of which is limited in underground mine rescue and recovery operations to situations where the wearer has ready access to fresh air and at least one crew equipped with approved self-contained breathing apparatus of 2 hours or longer rating, is in reserve at a fresh-air base.

(e) Certification and Quality Assurance Branch means the Certification and Quality Assurance Branch, Division of Safety Research, Appalachian Laboratory for Occupational Safety and Health, National Institute for Occupational Safety and Health, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888.

(f) Compressed-breathing gas means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form.

(g) dBA means sound pressure levels in decibels, as measured with the A-weighted network of a standard sound level meter using slow response.

(h) Dust means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic.

(i) Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres.

(j) Respirators for escape only means respiratory devices providing protection only during escape from hazardous atmospheres.

(k) A facepiece or mouthpiece is a respirator component designed to provide a gas-tight or dust-tight fit with the face and may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas source.

(l) Final inspection means that activity carried out on a product after all manufacturing and assembly operations are completed to insure completeness and adherence to performance or other specifications, including satisfactory appearance.

(m) Fume means a solid condensation particle, generally less than 1 micrometer in diameter.

(n) Gas means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure.

(o) Hazardous atmosphere means:

(1) Any atmosphere containing a toxic or disease producing gas, vapor, dust, fume, mist, or pesticide, either immediately or not immediately dangerous to life or health; or

(2) Any oxygen-deficient atmosphere.

(p) A hood or helmet is a respirator component which covers the wearer's head and neck, or head, neck, and shoulders, and is supplied with incoming respirable air for the wearer to breathe. It may include a headharness and connection for a breathing tube.

(q) Immediately dangerous to life or health means conditions that pose an immediate threat to life or health or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive materials, which are likely to have adverse cumulative or delayed effects on health.

(r) Incoming inspection means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements.

(s) In-process inspection means the control of products at the source of production and at each step of the manufacturing process, so that departures from specifications can be corrected before defective components or materials are assembled into the finished product.

(t) Institute means the National Institute for Occupational Safety and Health, Department of Health and Human Services.

(u) Liquefied-breathing gas means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form.

(v) Mist means a liquid condensation particle with a size ranging from submicroscopic to macroscopic.

(w) MSHA means the Mine Safety and Health Administration, U.S. Department of Labor.

(x) Not immediately dangerous to life or health means any hazardous atmosphere which may produce physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse physiological symptoms after prolonged exposure.

(y) Oxygen-deficient atmosphere means an atmosphere which contains an oxygen partial pressure of less than 148 millimeters of mercury (19.5 percent by volume at sea level).

(z) Powered air-purifying respirator means a device equipped with a facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, canister with filter, or cartridge with filter, and a blower.

(aa) Respirator means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere.

(bb) Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use.

(cc) Vapor means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure.

(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA), U.S. Department of Labor, shall jointly review and issue certifications for respirators used for mine emergencies and mine rescue, including any associated service-life plans, users’ manuals and other supporting documentation.

(2) Each certification for a respirator designed for mine rescue or other emergency use in mines shall include, as a condition of approval, any use limitations related to mine safety and health.

(b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints or identified deficiencies involving any respirators used in the mining environment.

(a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B.

(b) Applications shall be submitted to the Certification and Quality Assurance Branch, and shall be accompanied by a check, bank draft, or money order in the amount specified in subpart C of this part, payable to the order of the National Institute for Occupational Safety and Health.

(c) Except as provided in § 84.64, the examination, inspection, and testing of all respirators shall be conducted by the Certification and Quality Assurance Branch.

(d) Applicants, manufacturers, or their representatives may visit or communicate with the Certification and Quality Assurance Branch in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge shall be made for such consultation and no written report shall be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation.

(e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059.

(a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.

(b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies.

(c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.

(d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and shall include the results of such tests.

(e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.

(a) Each applicant shall, when an application is filed pursuant to § 84.10, be advised by the Institute of the total number of respirators and component parts required for testing.

(b) The applicant shall deliver, at his own expense, the number of completely assembled respirators and component parts required for testing, to the Certification and Quality Assurance Branch.

(c) Respirators and component parts submitted for approval must be made from materials specified in the application.

(d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

(e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate.

Except as provided in § 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of complete respirator assemblies:

Except as provided in § 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of the individual respirator components or subassemblies:

(a) Applications for the examination, inspection and testing of complete respirator assemblies which are not listed in § 84.20, or for the examination, inspection, and testing of respirator components or subassemblies which are not listed in § 84.21, shall be accompanied by the following deposits:

(b) The Institute reserves the right to conduct any examination, inspection, or test it deems necessary to determine the quality and effectiveness of any listed or unlisted respirator assembly or respirator component or subassembly, and to assess the cost of such examinations, inspections, or tests against the applicant prior to the issuance of any approval for such assembly, component, or subassembly.

(c) The fees charged for the examination, inspection, and testing of unlisted respirator assemblies, unlisted individual respirator components or subassemblies, and for the additional examination, inspection, and testing of listed respirator assemblies and components or subassemblies shall be at the rate of $100 per day for each man-day required to be expended by the Institute.

(d) Upon completion of all examinations, inspections, and tests of unlisted respirator assemblies or components, or following the completion of any additional examination, inspections, or tests of listed assemblies, or components or subassemblies, including retesting subsequent to disapproval, the Institute shall advise the applicant in writing of the total cost assessed and the additional amount, if any, which must be paid to the Institute as a condition of approval.

(e) In the event the amount assessed by the Institute for unlisted assemblies, or components or subassemblies is less than the amount of the deposit submitted in accordance with paragraph (a) of this section, the Institute shall refund the overpayment upon the issuance of any approval or notice of disapproval.

(a) The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable.

(b) The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly.

(c) The Institute shall not issue an informal notification of approval. However, if the application for approval, submitted in accordance with § 84.11, states that the submitted respirator and component parts are only prototypes, the Institute will examine, inspect, and test such respirator and component parts in accordance with the provisions of this part. If, upon completion of such examinations, inspections and tests, it is found that the prototype meets the minimum requirements set forth in this part, the Institute may inform the applicant, in writing, of the results of the examinations, inspections, and tests, and may require him to resubmit respirators and component parts made on regular production tooling, with no operations included which will not be incorporated in regular production processing, for further examination, inspection, and testing, prior to issuance of the certificate of approval.

(d) Applicants required to resubmit respirators and component parts made on regular production tooling, with no operation included which will not be incorporated in regular production processing, shall be charged fees in accordance with subpart C of this part.

(a) The certificate of approval shall contain a classification and a description of the respirator or combination of respirators for which it is issued, as provided in this part.

(b) The certificate of approval shall specifically set forth any restrictions or limitations on the respirator's use in hazardous atmospheres.

(c) Each certificate of approval shall be accompanied by the drawings and specifications (and lists thereof) submitted by the applicant in accordance with § 84.11. These drawings and specifications shall be referenced in the certificate of approval, and shall be maintained by the applicant. The drawings and specifications listed in each certificate of approval shall set forth in detail the design and construction requirements which shall be met by the applicant during commercial production of the respirator.

(d) Each certificate of approval shall be accompanied by a reproduction of the approval label design to be employed by the applicant with each approved respirator, as provided in § 84.33.

(e) No test data or specific laboratory findings will accompany any certificate of approval, however, the Institute will release pertinent test data and specific findings upon written request by the applicant, or as required by statute or regulation.

(f) Each certificate of approval shall also contain the approved quality control plan as specified in § 84.42.

(a) If, upon the completion of the examinations, inspections, and tests required to be conducted in accordance with the provisions of this part, it is found that the respirator does not meet the minimum requirements set forth in this part, the Institute shall issue a written notice of disapproval to the applicant.

(b) Each notice of disapproval shall be accompanied by all pertinent data or findings with respect to the defects of the respirator for which approval was sought with a view to the possible correction of any such defects.

(c) The Institute shall not disclose, except to the applicant or as required by statute or regulation, any data, findings, or other information with respect to any respirator for which a notice of disapproval is issued.

(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval.

(b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:

(f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.

(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.

The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval.

(a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of the original certificate of approval issued by the Institute for such respirator by filing an application for such modification in accordance with the provisions of this section.

(b) Applications shall be submitted as for an original certificate of approval, with a request for a modification of the existing certificate to cover any proposed change.

(c) The application shall be accompanied by appropriate drawings and specifications, and by a proposed quality control plan which meets the requirements of subpart E of this part.

(d) The application for modification, together with the accompanying material, shall be examined by the Institute to determine whether testing will be required.

(e) The Institute shall inform the applicant of the fee required for any additional testing and the applicant will be charged for the actual cost of any examination, inspection, or test required, and such fees shall be submitted in accordance with the provisions of subpart C of this part.

(f) If the proposed change or modification meets the requirements of this part, a formal certificate of modification will be issued, accompanied, where necessary, by a list of new and revised drawings and specifications covering the change(s) and reproductions of revised approval labels.

An approved respirator for which a formal certificate of modification has been issued shall be delivered, with proper markings and containers, by the applicant to the Certification and Quality Assurance Branch, as soon as it is commercially produced.

As a part of each application for approval or modification of approval submitted pursuant to this part, each applicant shall file with the Institute a proposed quality control plan which shall be designed to assure the quality of respiratory protection provided by the respirator for which approval is sought.

(a) Each quality control plan shall contain provisions for the management of quality, including:

(1) Requirements for the production of quality data and the use of quality control records;

(2) Control of engineering drawings, documentations, and changes;

(3) Control and calibration of measuring and test equipment;

(4) Control of purchased material to include incoming inspection;

(5) Lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant;

(6) Audit of final inspection of the completed product; and

(7) The organizational structure necessary to carry out these provisions.

(b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure, or an approved combination of sampling procedures. The procedure of Military Standard MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888. Incoming bulk raw material inspection or verification of specification, and in-process inspection shall be sufficient to ensure control of product quality through the manufacturing cycle.

(c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent.

(d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes:

(1) Critical. A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to life or health for individuals using or depending upon the respirator;

(2) Major A. A defect, other than critical, that is likely to result in failure to the degree that the respirator does not provide any respiratory protection, or a defect that reduces protection and is not detectable by the user;

(3) Major B. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is detectable by the user; and

(4) Minor. A defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the respirator.

(e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail.

(f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected.

(g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be:

(1) Major A. 1.0 percent;

(2) Major B. 2.5 percent; and

(3) Minor. 4.0 percent.

(h) Except as provided in paragraph (i) of this section, inspection level IV as described in MIL-STD-414, 11 June 1957, including Change Notice No.1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an equivalent procedure, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. Inspection level II as described in MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an equivalent procedure.

(i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to ensure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section.

(a) Each proposed quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in ensuring the quality of respiratory protection provided by the respirator for which an approval is sought.

(b) If the Institute determines that the proposed quality control plan submitted by the applicant will not ensure adequate quality control, the Institute shall require the applicant to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate of approval.

(c) Approved quality control plans shall constitute a part of and be incorporated into any certificate of approval issued by the Institute, and compliance with such plans by the applicant shall be a condition of approval.

(a) The applicant shall keep quality control inspection records sufficient to carry out the procedures required in MIL-STD-414, 11 June 1957, including Change Notice No. 1, “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” or an approved equivalent sampling procedure. MIL-STD-105D, 29 April 1963, “Sampling Procedures and Tables for Inspection by Attributes,” is an example of an approved equivalent sampling procedure. MIL-STD-414 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from DODSSP, Standardization Document Order Desk, 700 Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. Copies of MIL-STD-105D may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.

(b) The Institute reserves the right to have its representatives inspect the applicant's quality control test methods, equipment, and records, and to interview any employee or agent of the applicant in regard to quality control test methods, equipment, and records.

(c) The Institute reserves the right to revoke, for cause, any certificate of approval where it is found that the applicant's quality control test methods, equipment, or records do not ensure effective quality control over the respirator for which the approval was issued.

Approvals shall be issued for the types of respirators which have been classified pursuant to this subpart F, have been inspected, examined and tested by the Institute, in accordance with the provisions of subparts G through L of this part, and have been found to provide respiratory protection for fixed periods of time against the hazards specified in such approval.

Respirators described in subparts H through L of this part shall be classified for use as follows:

(a) Entry and escape. Respirators designed and approved for use during entry into a hazardous atmosphere, and for escape from a hazardous atmosphere; or

(b) Escape only. Respirators designed and approved for use only during escape from a hazardous atmosphere.

Respirators described in subparts H through L of this part shall be classified as approved for use against any or all of the following respiratory hazards:

(a) Oxygen deficiency;

(b) Gases and vapors; and

(c) Particles, including dusts, fumes and mists.

(a) The Institute shall issue approvals for the types of respirators described in subparts H through L of this part which have met the minimum requirements set forth for such respirators in this part.

(b) In addition to the types of respirators specified in subparts H through L of this part, the Institute shall issue approvals for other respiratory protective devices not specifically described in this part subject to such additional requirements as may be imposed in accordance with § 84.63(c).

(a) Respirators will not be accepted by the Institute for examination, inspection and testing unless they are designed on sound engineering and scientific principles, constructed of suitable materials and evidence good workmanship.

(b) Respirator components which come into contact with the wearer's skin shall be made of nonirritating materials.

(c) Components replaced during or after use shall be constructed of materials which will not be damaged by normal handling.

(d) Mouthpieces, hoods, helmets, and facepieces, except those employed in single-use respirators, shall be constructed of materials which will withstand repeated disinfection as recommended by the applicant in his instructions for use of the device.

(a) The component parts of each respirator shall be:

(1) Designed, constructed, and fitted to insure against creation of any hazard to the wearer;

(2) Assembled to permit easy access for inspection and repair of functional parts; and

(3) Assembled to permit easy access to parts which require periodic cleaning and disinfecting.

(b) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the respirator.

(a) Each respirator and respirator component shall when tested by the applicant and by the Institute, and meet the applicable requirements set forth in subparts H through L of this part.

(b) Where a combination respirator is assembled from two or more types of respirators, as described in this part, each of the individual respirator types which have been combined shall, as applicable, meet the minimum requirements for such respirators set forth in subparts H through L of this part, and such combination respirators, except as specified in § 84.70(b)(2), will be classified by the type of respirator in the combination which provides the least protection to the user.

(c) In addition to the minimum requirements set forth in subparts H through L of this part, the Institute reserves the right to require, as a further condition of approval, any additional requirements deemed necessary to establish the quality, effectiveness, and safety of any respirator used as protection against hazardous atmospheres.

(d) Where it is determined after receipt of an application that additional requirements will be required for approval, the Institute will notify the applicant in writing of these additional requirements, and necessary examinations, inspections, or tests, stating generally the reasons for such requirements, examinations, inspections, or tests.

(a) Prior to making or filing any application for approval or modification of approval, the applicant shall conduct, or cause to be conducted, examinations, inspections, and tests of respirator performance which are equal to or exceed the severity of those prescribed in this part.

(b) With the application, the applicant shall provide a statement to the Institute showing the types and results of the examinations, inspections, and tests required under paragraph (a) of this section and state that the respirator meets the minimum requirements of subparts H through L of this part, as applicable. Complete examination, inspection, and test data shall be retained on file by the applicant and be submitted, upon request, to the Institute.

(c) The Institute may, upon written request by the applicant, provide drawings and descriptions of its test equipment and otherwise assist the applicant in establishing a test laboratory or securing the services of a testing agency.

(d) No approval will be issued until the Institute has validated the applicant's test results.

(a) All examinations, inspections, and tests conducted pursuant to subparts H through L of this part will be under the sole direction and control of the Institute.

(b) The Institute may, as a condition of approval, require the assistance of the applicant or agents of the applicant during the assembly, disassembly, or preparation of any respirator or respirator component prior to testing or in the operation of such equipment during testing.

(c) Only Institute personnel, persons assisting the Institute pursuant to paragraph (b) of this section, and such other persons as are requested by the Institute or the applicant to be observers, shall be present during any examination, inspection, or test conducted prior to the issuance of an approval by the Institute for the equipment under consideration.

(d) The Institute shall hold as confidential any analyses, drawings, specifications, or materials submitted by the applicant and shall not disclose any principles or patentable features of such equipment, except as required by statute or regulation.

(e) As a condition of each approval issued for any respirator, the Institute reserves the right, following the issuance of such approval, to conduct such public tests and demonstrations of the approved respiratory equipment as is deemed appropriate.

(a) Any applicant may, upon a written request submitted to the Institute, withdraw any application for approval of any respirator.

(b) Upon receipt of a written request for the withdrawal of an application, the Institute shall determine the total man-days expended and the amount due for services already performed during the course of any examinations, inspections, or tests conducted pursuant to such application. The total amount due shall be determined in accordance with the provisions of § 84.22 and assessed against the fees submitted by the applicant. If the total amount assessed is less than the fees submitted, the Institute shall refund the balance together with a statement of the charges made for services rendered.

(a) Self-contained breathing apparatus, including all completely assembled, portable, self-contained devices designed for use as respiratory protection during entry into and escape from or escape only from hazardous atmospheres, are described as follows:

(1) Closed-circuit apparatus. An apparatus of the type in which the exhalation is rebreathed by the wearer after the carbon dioxide has been effectively removed and a suitable oxygen concentration restored from sources composed of:

(i) Compressed oxygen; or

(ii) Chemical oxygen; or

(iii) Liquid-oxygen.

(2) Open-circuit apparatus. An apparatus of the following types from which exhalation is vented to the atmosphere and not rebreathed:

(i) Demand-type apparatus. An apparatus in which the pressure inside the facepiece in relation to the immediate environment is positive during exhalation and negative during inhalation; or

(ii) Pressure-demand-type apparatus. An apparatus in which the pressure inside the facepiece in relation to the immediate environment is positive during both inhalation and exhalation.

(b) The following respirators may be classified as designed and approved for use during emergency entry into a hazardous atmosphere:

(1) A combination respirator which includes a self-contained breathing apparatus; and

(2) A Type “C” or Type “CE” supplied air respirator, where—

(i) The self-contained breathing apparatus is classified for 3-, 5-, or 10-minute service time and the air line supply is used during entry; or

(ii) The self-contained breathing apparatus is classified for 15 minutes or longer service time and not more than 20 percent of the rated capacity of the air supply is used during entry.

(c) Self-contained breathing apparatus classified for less than 1 hour service time will not be approved for use during underground mine rescue and recovery operations except as auxiliary equipment.

(d) Self-contained breathing apparatus classified for less than 30 minutes’ service time will not be approved for use as auxiliary equipment during underground mine rescue and recovery operations.

(a) Each self-contained breathing apparatus described in § 84.70 shall, where its design requires, contain the following component parts:

(1) Facepiece or mouthpiece, and noseclip;

(2) Respirable breathing gas container;

(3) Supply of respirable breathing gas;

(4) Gas pressure or liquid level gages;

(5) Timer;

(6) Remaining service life indicator or warning device;

(7) Hand-operated valves;

(8) Breathing bag;

(9) Safety relief valve or safety relief system; and

(10) Harness.

(b) The components of each self-contained breathing apparatus shall meet the minimum construction requirements set forth in subpart G of this part.

Flexible breathing tubes used in conjunction with breathing apparatus shall be designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces and mouthpieces;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each apparatus shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the apparatus in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of apparatus parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Apparatus may be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains, and all appropriate approval labels.

(b) Containers supplied by the applicant for carrying or storing self-contained breathing apparatus will be inspected, examined, and tested as components of the respirator for which approval is sought.

(c) Containers for self-contained breathing apparatus shall be designed and constructed to permit easy removal of the apparatus.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes, either:

(1) By providing more than one facepiece size; or

(2) By providing one facepiece size which will fit varying facial shapes and sizes.

(b) Full facepieces shall provide for the optional use of corrective spectacles or lenses which shall not reduce the respiratory protective qualities of the apparatus.

(c) Apparatus with mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or apparatus and provide an airtight seal.

(d) Facepieces shall be designed to prevent eyepiece, spectacle, and lens fogging.

(a) Facepieces shall be designed and constructed to provide adequate vision which is not distorted by the eyepiece.

(b) All eyepieces shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against damage and distortion.

(b) Exhalation valves shall be—

(1) Protected against external influence; and

(2) Designed and constructed to prevent inward leakage of contaminated air.

(a) Facepieces shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during suspension and an even distribution of pressure over the entire area in contact with the face.

(b) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses designed and constructed to hold the mouthpiece in place.

(a) Breathing gas used to supply apparatus shall be respirable and contain no less than 19.5 (dry atmosphere) volume percent of oxygen.

(b) Oxygen, including liquid oxygen, shall contain not less than 99.0 percent, by volume, of pure O2, not more than 0.03%, by volume, carbon dioxide, and not more than 0.001%, by volume, carbon monoxide. Methods for making these determinations can be found in the U.S. Pharmacopeia National Formulary. Containers used for oxygen must not be treated with any toxic, sleep-inducing, narcosis-producing, or respiratory tract irritating compounds.

(c) Compressed, gaseous breathing air shall meet the applicable minimum grade requirements for Type I gaseous air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade D or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(d) Compressed, liquefied breathing air shall meet the applicable minimum grade requirements for Type II liquid air set forth in the Compressed Gas Association Commodity Specification for Air, G-7.1, 1966 (Grade B or higher quality). G-7.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

Approvals shall not be issued by the Institute for any apparatus, combination of respirator assemblies, or any apparatus or respirator component which is designed or constructed to permit the interchangeable use of oxygen and air.

(a) Compressed breathing gas and liquefied breathing gas containers shall meet the minimum requirements of the Department of Transportation for interstate shipment of such containers when fully charged.

(b) Such containers shall be permanently and legibly marked to identify their contents, e.g., compressed breathing air, compressed breathing oxygen, liquefied breathing air, or liquefied breathing oxygen.

(c) Containers normally removed from apparatus for refilling shall be equipped with a dial indicating gage which shows the pressure in the container.

(d) Compressed breathing gas contained valves or a separate charging system or adapter provided with each apparatus shall be equipped with outlet threads specified for the service by the American Standards Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections, B57.1-1965. B57.1-1965 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(a) Gas pressure gages employed on compressed breathing gas containers shall be calibrated in pounds per square inch.

(b) Liquid-level gages shall be calibrated in fractions of total container capacity, or in units of liquid volume.

(c) Gas pressure gages other than those specified in paragraphs (a) and (b) of this section shall be calibrated in:

(1) Pounds per square inch; or

(2) In fractions of total container capacity; or

(3) Both in pounds per square inch and fractions of total container capacity.

(d)(1) Dial-indicating gages shall be reliable to within ±5 percent of full scale when tested both up and down the scale at each of 5 equal intervals.

(2) The full-scale graduation of dial-indicating gages shall not exceed 150 percent of the maximum rated cylinder pressures specified for the container in applicable Department of Transportation specifications or permits.

(e)(1) Stem-type gages shall be readable by sight and by touch and shall have a stem travel distance of not less than one-fourth inch between each graduation.

(2) A minimum of five graduations shall be engraved on the stem of each gage and these graduations shall include readings for empty, one-quarter, one-half, three-quarters, and full.

(3) Stem gage readings shall not vary from true readings by more than one-sixteenth inch per inch of stem travel.

(f) The loss of gas through a broken gage or severed gage connection shall not exceed 70 liters per minute when the cylinder pressure is 6,900 kN/m.2 (1,000 pounds per square inch gage) or when the liquid level is at one-half.

(g) Where gages are connected to the apparatus through a gage line, the gage and line shall be capable of being isolated from the apparatus except where the failure of the gage or line would not impair the performance or service life of the apparatus.

(h) Oxygen pressure gages shall have the words “Oxygen” and “Use No Oil” marked prominently on the gage.

(i)(1) Apparatus using compressed breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining gas content in the container.

(2) Apparatus using liquefied breathing gas, except apparatus classified for escape only, shall be equipped with gages visible to the wearer which indicate the remaining liquid content in the container; however, where the liquid content cannot be rapidly vented, and the service time of the device begins immediately after filling, a timer shall be provided in place of a visible gage.

(a) Elapsed time indicators shall be provided for apparatus with a chemical oxygen source, except:

(1) Apparatus used for escape only; or

(2) Liquefied breathing gas apparatus equipped with gages visible to the wearer which indicate the remaining liquid content in the container.

(b) The timer or other indicator shall be accurately calibrated in minutes of remaining service life.

(c) Timers shall be readable by sight and by touch during use by the wearer.

(d) Timers shall be equipped with automatically preset alarms which will warn the wearer for a period of 7 seconds or more after the preset time has elapsed.

(e) Remaining service-life indicators or warning devices shall be provided in addition to a pressure gage on compressed gas self-contained breathing apparatus, except apparatus used for escape only, and shall operate automatically without preadjustment by the wearer.

(f) Each remaining service-life indicator or warning device shall give an alarm when the remaining service life of the apparatus is reduced within a range of 20 to 25 percent of its rated service time.

(a) Hand-operated valves shall be designed and constructed to prevent removal of the stem from the valve body during normal usage to insure against a sudden release of the full pressure of the container when the valve is opened.

(b) Valves shall be designed or positioned to prevent accidental opening and closing, and damage from external forces.

(c) Valves operated during use of the apparatus shall be installed in locations where they can be readily adjusted by the wearer.

(d) Main-line valves, designed and constructed to conserve gas in the event of a regulator or demand valve failure, shall be provided in addition to gas container valves, except when such failure will not affect performance.

(e) Hand-operated bypass systems designed and constructed to permit the wearer to breathe and to conserve his gas supply in the event of a regulator or demand valve failure, shall be provided where necessary.

(f) Valves installed on apparatus shall be clearly distinguishable from one another by sight and touch.

(g) The bypass system valve control shall be colored red.

(h) A main-line or bypass valve or system will not be required on apparatus for escape only.

(i) Safety relief valves or systems, designed and constructed to release excess pressure in the breathing circuit, shall be provided on closed-circuit apparatus, and shall meet the following requirements:

(1) The relief valve or system shall operate automatically when the pressure in the breathing circuit on the inhalation side of the breathing bag reaches 13 mm. (one-half inch) water-column height of pressure above the minimum pressure required to fill the breathing bag, within the breathing resistance requirements for the apparatus.

(2) The relief valve or system shall be designed to prevent external atmospheres from entering the breathing circuit.

(3) The relief valve or system shall be designed to permit manual overriding for test purposes and in the event of a failure in the valve or system.

(a) Breathing bags shall have sufficient volume to prevent gas waste during exhalation and to provide an adequate reserve for inhalation.

(b) Breathing bags shall be constructed of materials which are flexible and resistant to gasoline vapors.

(c) Breathing bags shall be installed in a location which will protect them from damage or collapse by external forces, except on apparatus classified for escape only.

Each applicant shall certify that the materials employed in the construction of component parts exposed to oxygen pressures above atmospheric pressure are safe and compatible for their intended use.

All self-contained breathing apparatus using compressed gas shall have a filter downstream of the gas source to effectively remove particles from the gas stream.

(a) Breathing bags will be tested in an air atmosphere saturated with gasoline vapor at room temperature (24-30 °C./75-85 °F.) for a continuous period of twice the rated time of the apparatus (except for apparatus for escape only where the test period shall be the rated time of the apparatus).

(b) The bag will be operated during this test by a breathing machine with 24 respirations per minute and a minute-volume of 40 liters.

(c) A breathing machine cam with a work rate of 622 kp.-m./min. will be used. The dimensions of a suitable breathing machine cam are available from the Institute upon request.

(d) The air within the bag(s) shall not contain more than 100 parts per million of gasoline vapor at the end of the test.

(a) The completely assembled and fully charged apparatus shall not weigh more than 16 kg. (35 pounds); however, where the weight decreases by more than 25 percent of its initial charge weight during its rated service life, the maximum allowable weight of a completely assembled and fully charged apparatus shall be 18 kg. (40 pounds).

(b) Where an apparatus employs equipment which contributes materially to the wearer's comfort, e.g., a cooling system, the completely assembled and fully charged apparatus shall not weigh more than 18 kg. (40 pounds) regardless of the decrease in weight during use.

(a) Resistance to inhalation airflow will be measured in the facepiece or mouthpiece while the apparatus is operated by a breathing machine as described in § 84.88.

(b) The inhalation resistance of open-circuit apparatus shall not exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120 liters per minute).

(c) The inhalation resistance of closed-circuit apparatus shall not exceed the difference between exhalation resistance (§ 84.91(e)) and 10 cm. (4 inches) water-column height.

(a) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of open-circuit apparatus with air flowing at a continuous rate of 85 liters per minute.

(b) The exhalation resistance of demand apparatus shall not exceed 25 mm. (1 inch) water-column height.

(c) The exhalation resistance of pressure-demand apparatus shall not exceed the static pressure in the facepiece by more than 51 mm. (2 inches) water-column height.

(d) The static pressure (at zero flow) in the facepiece shall not exceed 38 mm. (1.5 inches) water-column height.

(e) Resistance to exhalation airflow will be measured in the facepiece or mouthpiece of closed-circuit apparatus with a breathing machine as described in § 84.88, and the exhalation resistance shall not exceed 51 mm. (2 inches) water-column height.

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. (1 inch) water-column height while in a normal operating position.

(b) Leakage between the valve and the valve seat shall not exceed 30 milliliters per minute.

(a) A static-flow test will be performed on all open-circuit apparatus.

(b) The flow from the apparatus shall be greater than 200 liters per minute when the pressure in the facepiece of demand-apparatus is lowered by 51 mm. (2 inches) water-column height when full container pressure is applied.

(c) Where pressure demand apparatus are tested, the flow will be measured at zero gage pressure in the facepiece.

(d) Where apparatus with compressed-breathing-gas containers are tested, the flow test shall also be made with 3,450 kN/m.2 (500 p.s.i.g.) container pressure applied.

(a) Where oxygen is supplied by a constant-flow device only, the rate of flow shall be at least 3 liters per minute for the entire rated service time of the apparatus.

(b) Where constant flow is used in conjunction with demand flow, the constant flow shall be greater than 1.5 liters per minute for the entire rated service time.

(c) All demand-flow devices shall provide at least 30 liters of oxygen per minute when in the fully open position.

(a) Service time will be measured with a breathing machine as described in § 84.88.

(b) The open-circuit apparatus will be classified according to the length of time it supplies air or oxygen to the breathing machine.

(c) The service time obtained on this test will be used to classify the open-circuit apparatus in accordance with § 84.53.

(a) The closed-circuit apparatus will be classified according to the length of time it supplies adequate breathing gas to the wearer during man test No. 4 described in Table 4 of this subpart.

(b) The service time obtained on man test No. 4 will be used to classify the closed-circuit apparatus in accordance with § 84.53.

(a) Open-circuit apparatus. (1) The concentration of carbon dioxide in inspired gas in open-circuit apparatus will be measured at the mouth while the apparatus mounted on a dummy head is operated by a breathing machine. An acceptable method for measuring the concentration of carbon dioxide is described in Bureau of Mines Report of Investigations 6865, A Machine-Test Method for Measuring Carbon Dioxide in the Inspired Air of Self-Contained Breathing Apparatus, 1966. Copies of Report of Investigations 6865 may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV. 26505-2888.

(2) The breathing rate will be 14.5 respirations per minute with a minute-volume of 10.5 liters.

(3) A sedentary breathing machine cam will be used.

(4) The apparatus will be tested at a temperature of 27 ± 2° C. (80 ± 5° F.).

(5) A concentration of 5 percent carbon dioxide in air will be exhaled into the facepiece.

(b) Closed-circuit apparatus. The concentration of carbon dioxide in inspired gas in closed-circuit apparatus will be measured at the mouth while the parts of the apparatus contributing to dead-air space are mounted on a dummy head and operated by the breathing machine as in paragraphs (a) (1) through (5) of this section.

(c) During the testing required by paragraphs (a) and (b) of this section, the concentration of carbon dioxide in inspired gas at the mouth will be continuously recorded, and the maximum average concentration during the inhalation portion of the breathing cycle shall not exceed the following limits:

(d) In addition to the test requirements for closed-circuit apparatus set forth in paragraph (b) of this section, gas samples will be taken during the course of the man tests described in Tables 1, 2, 3, and 4 of this subpart. These gas samples will be taken from the closed-circuit apparatus at a point downstream of the carbon dioxide sorbent, and they shall not contain more than 0.5 percent carbon dioxide at any time, except on apparatus for escape only, using a mouthpiece only, the sample shall not contain more than 1.5 percent carbon dioxide at any time.

(a) The applicant shall specify the minimum temperature for safe operation and two persons will perform the tests described in paragraphs (c) and (d) of this section, wearing the apparatus according to applicant's directions. At the specified temperature, the apparatus shall meet all the requirements described in paragraph (e) of this section.

(b) The apparatus will be precooled at the specified minimum temperature for 4 hours.

(c) The apparatus will be worn in the low temperature chamber for 30 minutes, or for the service time of the apparatus, whichever is less.

(d) During the test period, alternate 1-minute periods of exercise and rest will be required with the exercise periods consisting of stepping onto and off a box 21.5 cm. (81/2 inches) high at a rate of 30 cycles per minute.

(e)(1) The apparatus shall function satisfactorily at the specified minimum temperature on duplicate tests.

(2) The wearer shall have sufficient unobscured vision to perform the work.

(3) The wearer shall not experience undue discomfort because of airflow restriction or other physical or chemical changes in the operation of the apparatus.

(f) Auxiliary low-temperature parts which are commercially available to the user may be used on the apparatus to meet the requirements described in paragraph (e) of this section.

(a) The man tests described in Tables 1, 2, 3, and 4 of this subpart represent the workload performed in the mining, mineral, or allied industries by a person wearing the apparatus tested.

(b) The apparatus tested will be worn by Institute personnel trained in the use of self-contained breathing apparatus, and the wearer will, before participating in these tests, pass a physical examination conducted by a qualified physician.

(c) All man tests will be conducted by the Institute.

(d) The apparatus will be examined before each man test to ensure that it is in proper working order.

(e) Breathing resistance will be measured within the facepiece or mouthpiece and the wearer's pulse and respiration rate will be recorded during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.

(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.

(g) If man tests are not completed through no fault of the apparatus, the test will be repeated.

(a) Test 5 will be conducted to determine the maximum length of time the apparatus will supply the respiratory needs of the wearer while he is sitting at rest.

(b) The wearer will manipulate the devices controlling the supply of breathing gas to the advantage of the apparatus.

(c) Samples of inspiration from within the apparatus facepiece or mouthpiece shall be taken once every 15 minutes, and shall meet the minimum requirement for oxygen specified in § 84.79(a), and the maximum allowable average concentration of carbon dioxide specified in § 84.97(c).

(d) One sample of inspiration will be taken in the case of 3-, 5-, and 10-minute apparatus.

(a) Man test 6 will be conducted with respect to liquefied breathing gas apparatus only.

(b) This test will be conducted to evaluate operation of the apparatus in other than vertical positions.

(c) The wearer will lie face downward for one-fourth the service life of the apparatus with a full charge of liquefied breathing gas, and then a one-quarter full charge of liquefied breathing gas.

(d) The test will be repeated with the wearer lying on each side and on his back.

(e) The oxygen content of the gas supplied to the wearer by the apparatus will be continuously measured.

(a) The apparatus shall satisfy the respiratory requirements of the wearer for the classified service time.

(b) Fogging of the eyepiece shall not obscure the wearer's vision, and the wearer shall not experience undue discomfort because of fit or other characteristics of the apparatus.

(c) When the ambient temperature during testing is 24±6 °C. (75±10 °F.), the maximum temperature of inspired air recorded during man tests shall not exceed the following, after correction for deviation from 24 °C. (75 °F.):

(a) Non-powered air-purifying particulate respirators utilize the wearer's negative inhalation pressure to draw the ambient air through the air-purifying filter elements (filters) to remove particulates from the ambient air. They are designed for use as respiratory protection against atmospheres with particulate contaminants (e.g., dusts, fumes, mists) that are not immediately dangerous to life or health and that contain adequate oxygen to support life.

(b) Non-powered air-purifying particulate respirators are classified into three series, N-, R-, and P-series. The N-series filters are restricted to use in those workplaces free of oil aerosols. The R- and P-series filters are intended for removal of any particulate that includes oil-based liquid particulates.

(c) Non-powered air-purifying particulate respirators are classified according to the efficiency level of the filter(s) as tested according to the requirements of this part.

(1) N100, R100, and P100 filters shall demonstrate a minimum efficiency level of 99.97 percent.

(2) N99, R99, and P99 filters shall demonstrate a minimum efficiency level of 99 percent.

(3) N95, R95, and P95 filters shall demonstrate a minimum efficiency level of 95 percent.

(a) Each non-powered air-purifying particulate respirator described in § 84.170 shall, where its design requires, contain the following component parts:

(1) Facepiece, mouthpiece with noseclip, hood, or helmet;

(2) Filter unit;

(3) Harness;

(4) Attached blower; and

(5) Breathing tube.

(b) The components of each non-powered air-purifying particulate respirator shall meet the minimum construction requirements set forth in subpart G of this part.

Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and, where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Except as provided in paragraph (b) of this section each respirator shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type of respirator it contains, and all appropriate approval labels.

(b) Containers for single-use respirators may provide for storage of more than one respirator, however, such containers shall be designed and constructed to prevent contamination of respirators which are not removed, and to prevent damage to respirators during transit.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:

(1) By providing more than one facepiece size; or

(2) By providing one facepiece size which will fit varying facial shapes and sizes.

(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.

(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.

(d) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight seal.

(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.

(f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles.

Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.

(a) Inhalation and exhalation valves shall be protected against distortion.

(b) Inhalation valves shall be designed and constructed and provided where necessary to prevent excessive exhaled air from adversely affecting filters, except where filters are specifically designed to resist moisture.

(c) Exhalation valves shall be:

(1) Provided where necessary;

(2) Protected against damage and external influence; and

(3) Designed and constructed to prevent inward leakage of contaminated air.

(a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.

(b) Facepiece head harnesses, except those employed on single-use respirators, shall be adjustable and replaceable.

(c) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses, designed and constructed to hold the mouthpiece in place.

(a) The respirator manufacturer, as part of the application for certification, shall specify the filter series and the filter efficiency level (i.e., “N95”, “R95, “P95”, “N99, “R99”, “P99”, “N100”, “R100”, or “P100”) for which certification is being sought.

(b) Filters shall be prominently labeled as follows:

(1) N100 filters shall be labeled “N100 Particulate Filter (99.97% filter efficiency level)” and shall be a color other than magenta.

(2) R100 filters shall be labeled “R100 Particulate Filter (99.97% filter efficiency level)” and shall be a color other than magenta.

(3) P100 filters shall be labeled “P100 Particulate Filter (99.97% filter efficiency level)” and shall be color coded magenta.

(4) N99 filters shall be labeled “N99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.

(5) R99 filters shall be labeled “R99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.

(6) P99 filters shall be labeled “P99 Particulate Filter (99% filter efficiency level)” and shall be a color other than magenta.

(7) N95 filters shall be labeled as “N95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.

(8) R95 filters shall be labeled as “R95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.

(9) P95 filters shall be labeled as “P95 Particulate Filter (95% filter efficiency level)” and shall be a color other than magenta.

(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a particulate respirator (complete respirator) mounted on a test fixture with air flowing at continuous rate of 85±2 liters per minute, before each test conducted in accordance with § 84.182.

(b) The resistances for particulate respirators upon initial inhalation shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure.

(a) Twenty filters of each non-powered air-purifying particulate respirator model shall be tested for filter efficiency against:

(1) A solid sodium chloride particulate aerosol as per this section, if N-series certification is requested by the applicant.

(2) A dioctyl phthalate or equivalent liquid particulate aerosol as per this section, if R-series or P-series certification is requested by the applicant.

(b) Filters including holders and gaskets; when separable, shall be tested for filter efficiency level, as mounted on a test fixture in the manner as used on the respirator.

(c) Prior to filter efficiency testing of 20 N-series filters, the 20 to be tested shall be taken out of their packaging and placed in an environment of 85±5 percent relative humidity at 38±2.5 °C for 25±1 hours. Following the pre-conditioning, filters shall be sealed in a gas-tight container and tested within 10 hours.

(d) When the filters do not have separable holders and gaskets, the exhalation valves shall be blocked so as to ensure that leakage, if present, is not included in the filter efficiency level evaluation.

(e) For non-powered air-purifying particulate respirators with a single filter, filters shall be tested at a continuous airflow rate of 85±4 liters per minute. Where filters are to be used in pairs, the test-aerosol airflow rate shall be 42.5±2 liters per minute through each filter.

(f) Filter efficiency test aerosols. (1) When testing N-series filters, a sodium chloride or equivalent solid aerosol at 25±5 °C and relative humidity of 30±10 percent that has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be challenged with a concentration not exceeding 200 mg/m3.

(2) When testing R-series and P-series filters, a neat cold-nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25±5 °C that has been neutralized to the Boltzmann equilibrium state shall be used. Each filter shall be challenged with a concentration not exceeding 200 mg/m3.

(3) The test shall continue until minimum efficiency is achieved or until an aerosol mass of at least 200±5 mg has contacted the filter. For P-series filters, if the filter efficiency is decreasing when the 200±5 mg challenge point is reached, the test shall be continued until there is no further decrease in efficiency.

(g) The sodium chloride test aerosol shall have a particle size distribution with count median diameter of 0.075±0.020 micrometer and a standard geometric deviation not exceeding 1.86 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent. The DOP aerosol shall have a particle size distribution with count median diameter of 0.185±0.020 micrometer and a standard geometric deviation not exceeding 1.60 at the specified test conditions as determined with a scanning mobility particle sizer or equivalent.

(h) The efficiency of the filter shall be monitored and recorded throughout the test period by a suitable forward-light-scattering photometer or equivalent instrumentation.

(i) The minimum efficiency for each of the 20 filters shall be determined and recorded and be equal to or greater than the filter efficiency criterion listed for each level as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) Chemical cartridge respirators including all completely assembled respirators which are designed for use as respiratory protection during entry into or escape from atmospheres not immediately dangerous to life and health, are described according to the specific gases or vapors against which they are designed to provide respiratory protection, as follows:

(b) Chemical cartridge respirators for respiratory protection against gases or vapors, which are not specifically listed with their maximum use concentration, may be approved if the applicant submits a request for such approval, in writing, to the Institute. The Institute shall consider each such application and accept or reject the application after a review of the effects on the wearer's health and safety and in the light of any field experience in use of chemical cartridge respirators as protection against such hazards.

(a) Each chemical cartridge respirator described in § 84.190 shall, where its design requires, contain the following component parts:

(1) Facepiece, mouthpiece, and noseclip, hood, or helmet;

(2) Cartridge;

(3) Cartridge with filter;

(4) Harness;

(5) Breathing tube; and

(6) Attached blower.

(b) The components of each chemical cartridge respirator shall meet the minimum construction requirements set forth in subpart G of this part.

Where two or more cartridges are used in parallel, their resistance to airflow shall be essentially equal.

The color and markings of all cartridges or labels shall conform with the requirements of the American National Standards Institute, American National Standard for Identification of Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(a) Particulate matter filters used in conjunction with a chemical cartridge shall be located on the inlet side of the cartridge.

(b) Filters shall be incorporated in or firmly attached to the cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement on the cartridge.

Flexible breathing tubes used in conjunction with respirators shall be designed and constructed to prevent:

(a) Restriction of free head movement;

(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or helmets;

(c) Interference with the wearer's activities; and

(d) Shutoff of airflow due to kinking, or from chin or arm pressure.

(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts and, where applicable, provide for holding a full facepiece in the ready position when not in use.

Respirators shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type and commercial designation of the respirator it contains and all appropriate approval labels.

Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.

(a) Inhalation and exhalation valves shall be provided where necessary and protected against distortion.

(b) Inhalation valves shall be designed and constructed to prevent excessive exhaled air from entering cartridges or adversely affecting canisters.

(c) Exhalation valves shall be—

(1) Protected against damage and external influence; and

(2) Designed and constructed to prevent inward leakage of contaminated air.

(a)(1) Facepieces for chemical cartridge respirators other than single-use vinyl chloride shall be equipped with adjustable and replaceable head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.

(2) Facepieces for single-use vinyl chloride respirators shall be equipped with adjustable head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.

(b) Mouthpieces shall be equipped where applicable, with an adjustable and replaceable harness designed and constructed to hold the mouthpiece in place.

Noise levels generated by the respirator will be measured inside the hood or helmet at maximum airflow obtainable and shall not exceed 80 dBA.

(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a chemical cartridge respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with §§ 84.206 through 84.207.

(b) The maximum allowable resistance requirements for chemical cartridge respirators are as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) The complete chemical cartridge respirator will be fitted to the faces of persons having varying facial shapes and sizes.

(b) Where the applicant specifies a facepiece size or sizes for the respirator together with the approximate measurement of faces they are designed to fit, the Institute will provide test subjects to suit such facial measurements.

(c) Any chemical cartridge respirator part which must be removed to perform the facepiece or mouthpiece fit test shall be replaceable without special tools and without disturbing facepiece or mouthpiece fit.

(d) The facepiece or mouthpiece fit test using the positive or negative pressure recommended by the applicant and described in his instructions will be used before each test.

(e)(1) Each wearer will enter a chamber containing 100 p.p.m. isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for full facepieces, mouthpieces, hoods, and helmets.

(2) The facepiece or mouthpiece may be adjusted, if necessary, in the test chamber before starting the test.

(3) Each wearer will remain in the chamber for 8 minutes while performing the following activities:

(i) Two minutes, nodding and turning head;

(ii) Two minutes, calisthenic arm movements;

(iii) Two minutes, running in place; and

(iv) Two minutes, pumping with a tire pump into a 28-liter (1 cubic-foot) container.

(4) Each wearer shall not detect the odor of isoamyl-acetate vapor during the test.

(a) Three respirators with cartridges containing, or having attached to them, filters for protection against particulates will be tested in accordance with the provisions of § 84.207.

(b) In addition to the test requirements set forth in paragraph (a) of this section, three such respirators will be tested, as appropriate, in accordance with the provisions of §§ 84.179 through 84.183; however, the maximum allowable resistance of complete particulate, and gas, vapor, or gas and vapor chemical cartridge respirators shall not exceed the maximum allowable limits set forth in § 84.203.

(a) Bench tests will be made on an apparatus that allows the test atmosphere at 50±5 percent relative humidity and room temperature, approximately 25 °C, to enter the cartridges continuously at predetermined concentrations and rates of flow, and that has means for determining the test life of the cartridges.

(b) Where two cartridges are used in parallel on a chemical cartridge respirator, the bench test will be performed with the cartridges arranged in parallel, and the test requirements will apply to the combination rather than to the individual cartridges.

(c) Three cartridges or pairs of cartridges will be removed from containers and tested as received from the applicant.

(d) Two air purifying cartridges or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the flow rate of 25 liters per minute (l.p.m.) for 6 hours.

(e) Two air purifying cartridges or pairs of cartridges will be equilibrated by passing 85 percent relative humidity air through them at the flow rate of 25 l.p.m.

(f) All cartridges will be resealed, kept in an upright position, at room temperatures, and tested within 18 hours.

(g) Cartridges will be tested and shall meet the minimum requirements set forth in Table 11 of this subpart.

Vinyl chloride respirators, including all completely assembled respirators which are designed for use as respiratory protection during entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life, are described according to their construction as follows:

(a) Front-mounted or back-mounted gas masks;

(b) Chin-style gas masks;

(c) Chemical-cartridge respirators;

(d) Powered air-purifying respirators; and

(e) Other devices, including combination respirators.

(a) Except for the tests prescribed in § 84.126, the minimum requirements and performance tests for gas masks, prescribed in Subpart I of this part, are applicable to vinyl chloride gas masks.

(b) The following bench tests are applicable to canisters designed for use with gas masks for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(1) Four canisters will be equilibrated at 25±5 °C by passing 85±5 percent relative humidity air through them at 64 liters per minute for six hours.

(2) The equilibrated canisters will be resealed, kept in an upright position at room temperature, and tested according to paragraph (b)(3) of this section within 18 hours.

(3) The canisters equilibrated and stored as described in paragraphs (b) (1) and (2) of this section will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C to enter the canister continuously at a concentration of 25 ppm vinyl chloride monomer at a total flow rate of 64 liters per minute.

(4) The maximum allowable penetration after six hours of testing according to paragraph (b)(3) of this section shall not exceed 1 ppm vinyl chloride.

(c) Where canisters are submitted for testing and approval with a service life of more than four hours, the period of time for testing for vinyl chloride penetration will be performed at 150% of the service life specified in the manufacturer's application. (Example: If a manufacturer requests approval of a respirator for six hours use against exposure to vinyl chloride, the maximum allowable penetration after nine hours of testing shall not exceed 1 ppm vinyl chloride.)

(a) Except for the tests prescribed in §§ 84.206 and 84.207, the minimum requirements and performance tests for chemical-cartridge respirators prescribed in Subpart L of this part are applicable to replaceable-cartridge and single-use vinyl chloride chemical-cartridge respirators.

(b) The following bench tests are applicable to cartridges designed for use with chemical-cartridge respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(1) Where two cartridges are used in parallel on a chemical-cartridge respirator, the bench test requirements will apply to the combination rather than the individual cartridges.

(2) Four cartridges or pairs of cartridges will be equilibrated at 25±5 °C by passing 85±5 percent relative humidity air through them at 25 liters per minute for six hours.

(3) The equilibrated cartridges will be resealed, kept in an upright position, at room temperature, and tested according to paragraphs (b)(4) and (b)(5) of this section for other than single-use respirators or according to paragraphs (b)(6) and (b)(7) of this section for single-use respirators within 18 hours.

(4) The cartridges or pairs of cartridges for other than single-use respirators, equilibrated and stored as described in paragraphs (b)(1), (b)(2), and (b)(3) of this section, will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C, to enter the cartridges or pairs of cartridges continuously at a concentration of 10 ppm vinyl chloride monomer at a total flowrate of 64 liters per minute.

(5) The maximum allowable penetration after 90 minutes testing of cartridges or pairs of cartridges for other than single-use respirators, according to paragraph (b)(4) of this section shall not exceed 1 ppm vinyl chloride.

(6) The single-use respirators, equilibrated and stored as described in paragraphs (b)(2) and (b)(3) of this section, will be tested on an apparatus that allows a test atmosphere at 85±5 percent relative humidity and 25±5 °C to be cycled through the respirator by a breathing machine at a concentration of 10 ppm vinyl chloride monomer at the rate of 24 respirations per minute at a minute volume of 40±0.6 liters. Air exhaled through the respirator will be 35±2 °C with 94±3 percent relative humidity.

(7) The maximum allowable penetration after 144 minutes testing of respirators, according to paragraph (b)(6) of this section, shall not exceed 1 ppm vinyl chloride.

(a) Except for the tests prescribed in § 84.207, the minimum requirements and performance tests for powered air-purifying respirators prescribed in subpart L of this part are applicable to vinyl chloride powered air-purifying respirators.

(b) The following bench tests are applicable to cartridges designed for use with powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life:

(1) Four cartridges will be equilibrated at 25± °C by passing 85±5 percent relative humidity air through them at 115 liters per minute for tight-fitting facepieces and 170 liters per minute for loose-fitting hoods and helmets, for six hours.

(2) The equilibrated cartridges will be resealed, kept in an upright position at room temperature and tested according to paragraph (b)(3) of this section within 18 hours.

(3) The cartridges equilibrated and stored as described in paragraphs (b) (1) and (2) of this section will be tested on an apparatus that allows the test atmosphere at 85±5 percent relative humidity and 25±5 °C to enter the cartridge continuously at a concentration of 25 ppm vinyl chloride monomer at a total flow rate of 115 liters per minute for tight-fitting facepieces and 170 liters per minute for loose-fitting hoods and helmets.

(4) The maximum allowable penetration after six hours of testing according to paragraph (b)(3) of this section shall not exceed 1 ppm vinyl chloride.

(a) Each canister or cartridge submitted for testing and approval in accordance with §§ 84.252, 84.253, and 84.254 shall be equipped with a canister or cartridge end-of-service-life indicator which shows a satisfactory indicator change or other obvious warning before 1 ppm vinyl chloride penetration occurs. The indicator shall show such change or afford such warning at 80±10 percent of the total service life to 1 ppm leakage, as determined by continuing each test described in §§ 84.252(b), 84.253(b), and 84.254(b) until a 1 ppm leakage of vinyl chloride occurs.

(b) The applicant shall provide sufficient pretest data to verify the performance of the end-of-service-life indicator required in paragraph (a) of this section.

(a) In addition to the construction and performance requirements specified in §§ 84.251, 84.252, 84.253, 84.254, and 84.255, the quality control requirements in paragraphs (b), (c), and (d) of this section apply to approval of gas masks, chemical cartridge respirators, and powered air-purifying respirators for entry into and escape from vinyl chloride atmospheres containing adequate oxygen to support life.

(b) The respirators submitted for approval as described in paragraph (a) of this section shall be accompanied by a complete quality control plan meeting the requirements of subpart E of this part.

(c)(1) The applicant shall specify in the plan that a sufficient number of samples will be drawn from each bulk container of sorbent material and that where activated carbon is used, the following specific tests will be performed:

(i) Apparent density;

(ii) Iodine number;

(iii) Moisture content;

(iv) Carbon tetrachloride number; and

(v) Mesh size.

(2) The tests in paragraph (c)(1) of this section shall be performed in a quantity necessary to assure continued satisfactory conformance of the canisters and cartridges to the requirements of this subpart.

(d) Final performance quality control tests on the complete canisters and cartridges shall be accomplished using the bench tests and procedures prescribed in §§ 84.252, 84.253, 84.254, and 84.255.

(a) A warning shall be placed on the label of each gas mask, chemical-cartridge respirator, and powered air-purifying respirator, and on the label of each canister and cartridge, alerting the wearer to the need for a fitting test in accordance with the manufacturer's facepiece fitting instructions, providing service life information, providing specific instructions for disposal, and advising that the wearer may communicate to NIOSH any difficulties that may be experienced in the design and performance of any gas mask, chemical-cartridge respirator, or powered air-purifying respirator approved under the requirements of this subpart. The service lives of respirators meeting the test requirements of this subpart shall be specified as follows:

(b) Where the service life of a respirator is approved for more than four hours, the service life for which the respirator has been approved will be specified.

The following fees shall be charged for the examination, inspection, and testing of complete assemblies and components of respirators described in §§ 84.250 and 84.251:

The purpose of this subpart KK is to establish procedures and requirements for issuing extensions of approval of particulate respirators certified prior to July 10, 1995 under the provisions of 30 CFR part 11 (See 30 CFR part 11 edition, as revised July 1, 1994.), new approvals and extensions of approval of particulate respirators for applications that are in NIOSH receipt on July 10, 1995, and approval of powered air-purifying respirators.

(a) Air-purifying respirators with particulate filters approved under the provisions of this subpart after July 10, 1995 will have a 30 CFR part 11 approval label.

(b) Only changes or modifications of non-powered air-purifying respirators with particulate filters approved under the provisions of subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this section and deemed necessary by NIOSH to ensure the health and safety of the wearer will be approved until July 10, 1998 and will have a 30 CFR part 11 approval label.

(c) Only changes or modifications of powered air-purifying respirators with particulate filters approved under the provisions of subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this section and deemed necessary by NIOSH to ensure the health and safety of the wearer will be approved under this subpart until July 10, 1998 and will have a 30 CFR part 11 label.

(d) Approval of powered air-purifying respirators will be issued under this subpart. Particulate filters for powered air-purifying respirators approved under the provisions of this subpart shall be only high-efficiency (HEPA) as described in § 84.1130(a)(4) and will carry a 42 CFR part 84 approval label. In addition, changes or modifications of powered HEPA air-purifying respirators approved under the provisions of this subpart KK will be approved under this subpart and will have a 42 CFR part 84 approval label.

As used in this subpart

(a) Air Contamination Level means the standards of contaminant levels prescribed by the Secretary of Labor in accordance with the provisions of the Occupational Safety and Health Act of 1970 (Pub. L. 91-596; 84 Stat. 1590).

(b) DOP means a homogenous liquid aerosol, having a particle diameter of 0.3 micrometer, which is generated by vaporization and condensation of dioctyl phthalate.

(c) Pesticide means:

(1) Any substance or mixture of substances (including solvents and impurities) intended to prevent, destroy, repel, or mitigate any insect, rodent, nematode, fungus, weed, or other form of plant or animal life or virus; and

(2) Any substance or mixture of substances (including solvents and impurities) intended for use as a plant regulator, defoliant, or desiccant, as defined in the Federal Insecticide, Fungicide, and Rodenticide Act of 1947, as amended (7 U.S.C. 135-135k), excluding fumigants which are applied as gases or vapors or in a solid or liquid form as pellets or poured liquids for subsequent release as gases or vapors.

(d) Radionuclide means an atom identified by the constitution of its nucleus (specified by the number of protons Z, number of neutrons N, and energy, or, alternatively, by the atomic number Z, mass number A=(N+Z), and atomic mass) which exists for a measurable time; decays or disintegrates spontaneously, emits radiation, and results in the formation of new nuclides.

(e) Smoke means the products of incomplete combustion of organic substances in the form of solid and liquid particles and gaseous products in air, usually of sufficient concentration to perceptibility obscure vision.

The following fees shall be charged by the Institute for the examination, inspection and testing of complete respirator assemblies approved under this subpart:

(a) Gas masks with particulate filter, including pesticide gas masks—

(1) Single hazard—$1,100.

(2) Type N—$4,100.

(b) Dust, fume and mist respirators—

(1) Single particulate hazard having an Air Contamination Level more than 0.05 mg./m.3 or 2 million particles per cubic foot—$500.

(2) Combination particulate hazards having an Air Contamination Level more than 0.05 mg./m.3 or 2 million particles per cubic foot—$750.

(3) Particulate hazards having an Air Contamination Level less than 0.05 mg./m.3 or 2 million particles per cubic foot, radon daughters —$1,250.

(4) All dusts, fumes and mists—$2,000.

(c) Paint spray respirators—$1,600.

(d) Pesticide respirators—$1,600.

(e) Chemical cartridge respirators with particulate filter—$1,150.

(a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to MSHA and the Institute for approval.

(b) Approval labels for non-powered and powered air-purifying dust, fume, mist respirators approved prior to July 10, 1995 under the provisions of subpart K of 30 CFR part 11 (See 30 CFR Part 11 edition, revised as of July 1, 1994.) shall bear the emblem of the Mine Safety and Health Administration and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute, a statement that the respirator was tested and approved under subpart K of 30 CFR part 11 and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) Approval labels for powered air-purifying respirators approved under the provisions of this subpart shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute, a statement stating the respirator was tested under the provisions of this subpart, and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number.

(c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required.

(d) Approval labels and markings shall only be used by the applicant to whom they were issued.

(e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations:

(f) The use of any MSHA and Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based.

(g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture.

(a) Dust, fume, and mist respirators, including all completely assembled respirators designed for use as respiratory protection during entry into and escape from atmospheres which contain adequate oxygen to support life and hazardous particulates, are described as follows:

(1) Air-purifying respirators, either with replaceable or reusable filters, designed as respiratory protection against dusts:

(i) Having an air contamination level not less than 0.05 milligram per cubic meter of air, including but not limited to coal, arsenic, cadmium, chromium, lead, and manganese; or

(ii) Having an air contamination level not less than 2 million particles per cubic foot of air, including but not limited to aluminum, flour, iron ore, and free silica, resulting principally from the disintegration of a solid, e.g., dust clouds produced in mining, quarrying, and tunneling, and in dusts produced during industrial operations, such as grinding, crushing, and the general processing of minerals and other materials.

(2) Air-purifying respirators, with replaceable filters, designed as respiratory protection against fumes of various metals having an air contamination level not less than 0.05 milligram per cubic meter, including but not limited to aluminum, antimony, arsenic, cadmium, chromium, copper, iron, lead, magnesium, manganese, mercury (except mercury vapor), and zinc, which result from the sublimation or condensation of their respective vapors, or from the chemical reaction between their respective vapors and gases.

(3) Air-purifying respirators, with replaceable filters, designed as respiratory protection against mists of materials having an air contamination level not less than 0.05 milligram per cubic meter or 2 million particles per cubic foot, e.g., mists produced by spray coating with vitreous enamels, chromic acid mist produced during chromium plating, and other mists of materials whose liquid vehicle does not produce harmful gases or vapors.

(4) Air-purifying respirators, with replaceable filters, designed as respiratory protection against dusts, fumes, and mists having an air contamination level less than 0.05 milligram per cubic meter, including but not limited to lithium hydride and beryllium, and against radionuclides.

(5) Air-purifying respirators, with replaceable filters, designed as respiratory protection against radon daughters, and radon daughters attached to dusts, fumes, and mists.

(6) Air-purifying respirators, with replaceable filters, designed as respiratory protection against asbestos-containing dusts and mists.

(7) Air-purifying respirators, with replaceable filters, designed as protection against various combinations of particulate matter.

(8) Air-purifying dust respirators designed as respiratory protection against pneumoconiosis- and fibrosis-producing dusts, or dusts and mists, including but not limited to aluminum, asbestos, coal, flour, iron ore, and free silica.

(b) Gas masks containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the canister.

(c) Pesticide respirators, including all completely assembled respirators which are designed for use as respiratory protection during entry into and escape from atmospheres which contain pesticide hazards, are described according to their construction as follows:

(1) Front-mounted or back-mounted gas masks;

(2) Chin-style gas mask;

(3) Chemical cartridge;

(4) Air-purifying respirator with attached blower; and,

(5) Other devices, including combination respirators.

(d) Respirators with cartridges containing or having attached to them, filters for protection against mists of paints, lacquers, and enamels. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the cartridge.

(e) Respirators with cartridges containing or having attached to them filters for protection against dusts, fumes, and mists, except the mists of paints, lacquers, and enamels. These respirators are not for use against gases or vapors with poor warning properties (except where MSHA or Occupational Safety and Health Administration standards may permit such use for a specific gas or vapor) or those which generate high heats of reaction with sorbent material in the cartridge.

(a) Each respirator described in § 84.1130 shall, where its design requires, contain the following component parts:

(1) Facepiece, mouthpiece with noseclip, hood, or helmet;

(2) Filter unit, canister with filter, or cartridge with filter;

(3) Harness;

(4) Attached blower; and

(5) Breathing tube.

(b) The components of each respirator shall meet the minimum construction requirements set forth in Subpart G of this part.

(a) Each respirator shall, where necessary, be equipped with a suitable harness designed and constructed to hold the components of the respirator in position against the wearer's body.

(b) Harnesses shall be designed and constructed to permit easy removal and replacement of respirator parts, and, where applicable, provide for holding a full facepiece in the ready position when not in use.

(a) Except as provided in paragraph (b) of this section each respirator shall be equipped with a substantial, durable container bearing markings which show the applicant's name, the type of respirator it contains, and all appropriate approval labels. Except for dust, fume, and mist respirators, the commercial designation of the respirator it contains shall be shown.

(b) Containers for single-use respirators may provide for storage of more than one respirator, however, such containers shall be designed and constructed to prevent contamination of respirators which are not removed, and to prevent damage to respirators during transit.

(c) Containers for gas masks combinations shall be designed and constructed to permit easy removal of the mask.

(a) Half-mask facepieces and full facepieces shall be designed and constructed to fit persons with various facial shapes and sizes either:

(1) By providing more than one facepiece size; or

(2) By providing one facepiece size which will fit varying facial shapes and sizes.

(b) Full facepieces shall provide for optional use of corrective spectacles or lenses, which shall not reduce the respiratory protective qualities of the respirator.

(c) Hoods and helmets shall be designed and constructed to fit persons with various head sizes, provide for the optional use of corrective spectacles or lenses, and insure against any restriction of movement by the wearer.

(d) Mouthpieces shall be equipped with noseclips which are securely attached to the mouthpiece or respirator and provide an airtight seal.

(e) Facepieces, hoods, and helmets shall be designed to prevent eyepiece fogging.

(f) Half-mask facepieces shall not interfere with the fit of common industrial safety corrective spectacles, as determined by the Institute's facepiece tests in §§ 84.1141, 84.1142, and 84.1156(b).

(a) Facepieces, hoods, and helmets shall be designed and constructed to provide adequate vision which is not distorted by the eyepieces.

(b) All eyepieces of gas masks combinations shall be designed and constructed to be impact and penetration resistant. Federal Specification, Mask, Air Line: and Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965, with interim amendment-1, July 30, 1969, is an example of an appropriate standard for determining impact and penetration resistance. Copies of GGG-M-125d may be obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.

(a) Inhalation and exhalation valves shall be protected against distortion.

(b) Inhalation valves shall be designed and constructed and provided where necessary to prevent excessive exhaled air from adversely affecting filters, cartridges, and canisters, except where filters of dust, fume, and mist respirators are specifically designed to resist moisture as prescribed in § 84.1145.

(c) Exhalation valves shall be:

(1) Provided where necessary;

(2) Protected against damage and external influence; and

(3) Designed and constructed to prevent inward leakage of contaminated air.

(a) All facepieces shall be equipped with head harnesses designed and constructed to provide adequate tension during use and an even distribution of pressure over the entire area in contact with the face.

(b) Facepiece head harnesses, except those employed on single-use dust, fume, and mist respirators, shall be adjustable and replaceable.

(c) Mouthpieces shall be equipped, where applicable, with adjustable and replaceable harnesses, designed and constructed to hold the mouthpiece in place.

Noise levels generated by the respirator will be measured inside the hood or helmet at maximum airflow obtainable and shall not exceed 80 dBA.

Dust, fume, and mist respirators and the individual components of each such device shall, as appropriate, meet the requirements for performance and protection specified in the tests described in §§ 84.1141 through 84.1152 and prescribed in Tables 12 and 13.

(a) The respirator will be modified in such a manner that all of the air that normally would be inhaled through the inhalation port(s) is drawn through an efficient activated charcoal-filled canister, or cartridge(s), without interference with the face-contacting portion of the facepiece.

(b) The modified respirator will be worn by persons for at least 2 minutes each in a test chamber containing 100 parts (by volume) of isoamyl-acetate vapor per million parts of air.

(c) The odor of isoamyl-acetate shall not be detected by the wearers of the modified respirator while in the test atmosphere.

(a) The applicant shall provide a charcoal-filled canister or cartridge of a size and resistance similar to the filter unit with connectors which can be attached to the facepiece in the same manner as the filter unit.

(b)(1) The canister or cartridge will be used in place of the filter unit, and persons will each wear a modified half-mask facepiece for 5 minutes in a test chamber containing 100 parts (by volume) of isoamyl-acetate vapor per million parts of air.

(2) The following work schedule will be performed by each wearer in the test chamber:

(i) Two minutes walking, nodding, and shaking head in normal movements; and

(ii) Three minutes exercising and running in place.

(3) The facepiece shall be capable of adjustment, according to the applicant's instructions, to each wearer's face, and the odor of isoamyl-acetate shall not be detectable by any wearer during the test.

(c) Where the respirator is equipped with a full facepiece, hood, helmet, or mouthpiece, the canister or cartridge will be used in place of the filter unit, and persons will each wear the modified respiratory-inlet covering for 5 minutes in a test chamber containing 1,000 parts (by volume) of isoamyl-acetate vapor per million parts of air, performing the work schedule specified in paragraph (b)(2) of this section.

Dust, fume, and mist respirators will be tested in accordance with the schedule set forth in Table 13 of this subpart to determine their effectiveness as protection against the particulate hazards specified in Table 13.

(a) Three non-powered respirators with single-use filters will be tested for periods of 90 minutes each at a continuous airflow rate of 32 liters per minute.

(b) The relative humidity in the test chamber will be 20-80 percent, and the room temperature approximately 25° C.

(c) The test suspension in the chamber will not be less than 50 nor more than 60 milligrams of flint (99+ percent free silica) per cubic meter of air.

(d) The flint in suspension will be ground to pass 99+ percent through a 270-mesh sieve.

(e) The particle-size distribution of the test suspension will have a geometric mean of 0.4 to 0.6 micrometer, and the standard geometric deviation will not exceed 2.

(f) The total amount of unretained test suspension in samples taken during testing shall not exceed 1.5 milligrams for a non-powered air-purifying respirator.

(g) Three non-powered respirators with reusable filters will be tested and shall meet the requirements specified in paragraphs (a) through (f) of this section; each filter shall be tested three times: Once as received; once after cleaning; and once after recleaning. The applicant's instructions shall be followed for each cleaning.

(a) Three respirators will be tested.

(b) As described in § 84.1144, airflow will be cycled through the respirator by a breathing machine at the rate of 24 respirations per minute with a minute volume of 40 liters; a breathing machine cam with a work rate of 622 kg.-m.2/minute shall be used.

(c) Air exhaled through the respirator will be 35° ±2° C. with 94 ±3 percent relative humidity. #

(d) Air inhaled through the respirator will be sampled and analyzed for respirator leakage.

(e) The total amount of unretained test suspension, after drying, in samples taken during testing, shall not exceed 1.8 milligrams for any single test.

(a) Three non-powered respirators will be tested for a period of 312 minutes each at a continuous airflow rate of 32 liters per minute.

(b) The relative humidity in the test chamber will be 20-80 percent, and the room temperature approximately 25° C.

(c) The test suspension in the test chamber will not be less than 15 nor more than 20 milligrams of freshly generated lead-oxide fume, calculated as lead (Pb), per cubic meter of air.

(d) The fume will be generated by impinging an oxygen-gas flame on molten lead.

(e) Samples of the test suspension will be taken during each test period for analysis.

(f) The total amount of unretained test suspension in the samples taken during testing, which is analyzed and calculated as lead (Pb), shall not exceed 1.5 milligrams of lead for a non-powered air-purifying respirator.

Respirators designed as respiratory protection against more than one particulate hazard (dust, fume, or mist) shall comply with all the requirements of this part, with respect to each of the specific hazards involved.

(a) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a dust, fume, or mist respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with §§ 84.1144 through 84.1147.

(b) The maximum allowable resistance requirements for dust, fume, and mist respirators are as follows:

(a) Dry exhalation valves and valve seats will be subjected to a suction of 25 mm. water-column height while in a normal operating position.

(b) Leakage between the valve and valve seat shall not exceed 30 milliliters per minute.

(a) All single air-purifying respirator filter units will be tested in an atmosphere concentration of 100 micrograms of DOP per liter of air at continuous flow rates of 32 and 85 liters per minute for a period of 5 to 10 seconds.

(b) Where filters are to be used in pairs, the flow rates will be 16 and 42.5 liters per minute, respectively, through each filter.

(c) The filter will be mounted on a connector in the same manner as used on the respirator, and the total leakage for the connector and filter shall not exceed 0.03 percent of the ambient DOP concentration at either flow rate.

(a) Gas mask canisters containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors, will be tested as prescribed in § 84.1140 except for the breathing resistance which will be in accordance with § 84.122.

(b) Gas mask canisters designed for protection against smokes will be tested in an atmospheric concentration of 100 micrograms of dioctyl phthalate per liter of air at continuous flow rates of 32 liters per minute and 85 liters per minute for a period of 5 to 10 seconds, and the DOP leakage through the canister shall not exceed 0.03 percent of the test concentration.

(c) Gas mask canisters containing filters for protection against dusts, fumes, mists, and smokes in combination with gases, vapors, or gases and vapors, will be tested as prescribed in § 84.126.

(a) Where two or more canisters or cartridges are used in parallel, their resistance to airflow shall be essentially equal.

(b) The color and markings of all canisters and cartridges or labels shall conform with the requirements of the American National Standards Institute, American National Standard for Identification of Air-Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI K13.1 is incorporated by reference and has been approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American National Standards Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be inspected at the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(a) Particulate matter filters used in conjunction with a canister or cartridge shall be located on the inlet side of the canister or cartridge.

(b) Filters shall be incorporated into or firmly attached to the canister or cartridge and each filter assembly shall, where applicable, be designed to permit its easy removal from and replacement on the canister or cartridge.

Pesticide respirators and the individual components of each such device shall, as appropriate, meet the following minimum requirements for performance and protection:

(a) Breathing resistance test. (1) Airflow resistance will be measured in the facepiece, mouthpiece, hood, or helmet of a pesticide respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with paragraphs (c) and (f) of this section.

(2) The maximum allowable resistance requirements for pesticide respirators are as follows:

(b) Facepiece test. (1) The complete pesticide respirator will be fitted to the faces of persons having varying facial shapes and sizes.

(2) Where the applicant specifies a facepiece size or sizes for his respirator together with the approximate measurements of faces they are designed to fit, the Institute will provide test subjects to suit such facial measurements.

(3) Any pesticide respirator part which must be removed to perform the facepiece fit test shall be replaceable without special tools and without disturbing facepiece fit.

(4) The facepiece or mouthpiece fit test using positive or negative pressure recommended by the applicant and described in his instructions will be used during each test.

(5)(i) Each wearer will enter a chamber containing 1,000 p.p.m. isoamyl-acetate vapor for a respirator equipped with a full facepiece, mouthpiece, hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a respirator equipped with a half-mask facepiece.

(ii) The facepiece, mouthpiece, hood, or helmet may be adjusted, if necessary, in the test chamber before starting the test.

(iii) Each wearer will remain in the chamber while performing the following activities:

(A) Two minutes, nodding and turning head;

(B) Two minutes, calisthenic arm movements;

(C) Two minutes, running in place; and

(D) Two minutes, pumping with a tire pump into a 28-liter (1 cubic foot) container.

(iv) Each wearer shall not detect the odor of isoamyl-acetate during the test.

(c) Silica dust test. Three completely assembled pesticide respirators will be tested with a mechanical-testing apparatus as follows:

(1) Temperature in the test chamber will be approximately 25° C.

(2) Continuous airflow through the respirator will be 32 liters per minute for front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators, and not less than 115 (4 cubic feet) liters per minute to tight-fitting facepieces and 170 liters (6 cubic feet) per minute to loose-fitting hoods and helmets of powered air-purifying respirators.

(3) The test aerosol will contain 50-60 milligrams of 99+ percent free silica per cubic meter of air.

(4) The particle size distribution of the test suspension will have a geometric mean diameter of 0.4 to 0.6 micrometer, with a standard geometric deviation less than 2.

(5) Front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators will be tested for 90 minutes and powered air-purifying respirators will be tested for 4 hours.

(d) Lead fume test. Three completely assembled pesticide respirators will be tested with a mechanical-testing apparatus as follows:

(1) Continuous airflow through the respirator will be 32 liters per minute for front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators and not less than 115 liters (4 cubic feet) per minute, for powered air-purifying respirators with tight-fitting facepieces, and not less than 170 liters (6 cubic feet) per minute for powered air-purifying respirators with loose-fitting hoods and helmets.

(2) The test aerosol will contain 15-20 milligrams of freshly generated lead-oxide fume, calculated as lead, per cubic meter of air.

(3) The fume will be generated by impinging an oxygen-gas flame on molten lead.

(4) Front-mounted, back-mounted, and chin-style gas mask pesticide respirators and chemical cartridge pesticide respirators will be tested for 90 minutes and powered air-purifying pesticide respirators will be tested for 4 hours.

(5) The total amount of unretained test suspension, which is analyzed and calculated as lead, shall not exceed:

(i) 0.43 milligram for any 90-minute test;

(ii) 4.8 milligrams for any 4-hour test made at 115 liters (4 cubic feet) per minute; or

(iii) 6.2 milligrams for any 4-hour test made at 170 liters (6 cubic feet) per minute.

(e) Dioctyl-phthalate test. (1) All canisters submitted for use with front-mounted and back-mounted gas mask pesticide respirators will be tested in an atmospheric concentration of 100 micrograms of dioctyl-phthalate per liter of air at continuous flow rates of 32 and 85 liters per minute for a test period of 5 to 10 seconds.

(2) The DOP leakage through the canister shall not exceed 0.03 percent of the ambient DOP concentration.

(f) Bench tests for pesticide respirators. (1)(i) Bench tests will be made on an apparatus that allows the test atmosphere at 50±5 percent relative humidity and at room temperature (25°±2.5° C.) to enter the canister or cartridge at predetermined concentrations and rates of flow, and that has a means for determining the test life of the canister or cartridge against carbon tetrachloride.

(ii) Canisters and cartridges will be tested as they are used on each pesticide respirator, either singly or in pairs.

(iii) Three canisters or cartridges or pairs of cartridges will be removed from containers and tested as received from the applicant.

(iv) Two canisters, cartridges, or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the following flow rates (expressed as liters per minute (l.p.m.)) for 6 hours:

(v) Two canisters, cartridges, or pairs of cartridges will be equilibrated at room temperature by passing 85 percent relative humidity air through them at the flow rates stated in paragraph (f)(1)(iv) of this section for 6 hours.

(vi) The equilibrated canisters or cartridges will be resealed, kept in an upright position at room temperature, and tested within 18 hours.

(2) Canisters and cartridges tested in accordance with the provisions of this section shall meet the requirements specified in Table 14 of this subpart.

Chemical cartridge respirators with particulate filters and the individual components of each such device shall, as appropriate, meet the following minimum requirements for performance and protection:

(a) Breathing resistance test. (1) Resistance to airflow will be measured in the facepiece, mouthpiece, hood, or helmet of a chemical cartridge respirator mounted on a test fixture with air flowing at a continuous rate of 85 liters per minute, both before and after each test conducted in accordance with paragraphs (d) through (f) of this section.

(2) The maximum allowable resistance requirements for chemical cartridge respirators are as follows:

(b) Facepiece test. The facepiece test will be conducted as specified in § 84.205.

(c) Lacquer and enamel mist tests; general. (1) Three respirators with cartridges containing or having attached to them, filters for protection against mists of paints, lacquers, and enamels shall be tested in accordance with the provisions of paragraph (f) of this section.

(2) In addition to the test requirements set forth in paragraph (c)(1) of this section, three such respirators will be tested against each aerosol in accordance with the provisions of paragraphs (d) and (e) of this section.

(d) Lacquer mist test. (1) Temperature in the test chamber will be approximately 25° C.

(2) Continuous airflow through the respirator will be 32 liters per minute for air-purifying respirators, and not less than 115 liters per minute to tight fitting facepieces and 170 liters per minute to loose-fitting hoods and helmets of powered air-purifying respirators.

(3) Airflow through the chamber will be 20-25 air changes per minute.

(4) The atomizer employed will be a No. 64-5 nozzle with setup 3, or equivalent, operating at 69 kN/m.2 (10 pounds per square inch gage).

(5) The test aerosol will be prepared by atomizing a mixture of one volume of clear cellulose nitrate lacquer and one volume of lacquer thinner. The lacquer described in Federal Specification TT-L-31, October 7, 1953, is an example of an acceptable lacquer. Copies of TT-L-31 may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.

(6) The concentration of cellulose nitrate in the test aerosol will be 95-125 milligrams per cubic meter.

(7) The test aerosol will be drawn to each respirator for a total of 156 minutes for air-purifying respirators and 240 minutes for powered air-purifying respirators.

(8) The total amount of unretained mist in the samples taken during testing, weighed as cellulose nitrate, shall not exceed 5 milligrams for an air-purifying respirator, 28 milligrams for a powered air-purifying respirator with tight-fitting facepiece, and 41 milligrams for a powered air-purifying respirator with loose-fitting hood or helmet.

(e) Enamel mist test. (1) Temperature in the test chamber will be approximately 25° C.

(2) Continuous airflow through the respirator will be 32 liters per minute for air-purifying respirators, and not less than 115 liters per minute to tight-fitting facepieces and 170 liters per minute to loose-fitting hoods and helmets of powered air-purifying respirators.

(3) Airflow through the chamber will be 20-25 air changes per minute.

(4) The atomizer employed will be a No. 64 nozzle with setup 1A, or equivalent, operating at 69 kN/m.2 (10 pounds per square inch gage).

(5) The test aerosol will be prepared by atomizing a mixture of 1 volume of white enamel and 1 volume of turpentine. The enamel described in Federal Specification TT-E-489b, May 12, 1953, with amendment-1 of 9 November 1955 is an example of an acceptable enamel. Copies of TT-E-489b may be inspected or obtained from the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.

(6) The concentration of pigment in the test aerosol, weighed as ash, will be 95-125 milligrams per cubic meter.

(7) The test aerosol will be drawn to each respirator for a total of 156 minutes for air-purifying respirators and 240 minutes for power air-purifying respirators.

(8) The total amount of unretained mist in the samples taken during testing, weighed as ash, shall not exceed 1.5 milligrams for any air-purifying respirator, 8.3 milligrams for a powered air-purifying respirator with tight-fitting facepiece, and 12.3 milligrams for a powered air-purifying respirator with loose-fitting hood or helmet.

(f) Bench tests; gas and vapor tests. (1) Bench tests will be made in accordance with § 84.207 and tested cartridges shall meet the minimum requirements set forth in Table 11 of subpart L of this part. Cartridges will be equilibrated in accordance with paragraph (f)(2) of this section.

(2)(i) Two powered air-purifying cartridges or pairs of cartridges will be equilibrated at room temperature by passing 25 percent relative humidity air through them at the following flow rates (expressed in liters per minute (l.p.m.)) for 6 hours:

(ii) Two powered air-purifying cartridges or pairs of cartridges will be equilibrated by passing 85 percent relative humidity air through them at the flow rates stated in paragraph (f)(2)(i) of this section.

(iii) All cartridges will be resealed, kept in an upright position, at room temperatures, and tested within 18 hours.

(a) Three respirators with cartridges containing, or having attached to them, filters for protection against dusts, fumes, and mists, except the mists of paints, lacquers, and enamels, will be tested in accordance with the provisions of § 84.1157(f).

(b) In addition to the test requirements set forth in paragraph (a) of this section, three such respirators will be tested, as appropriate, in accordance with the provisions of §§ 84.1141 through 84.1152; however, the maximum allowable resistance of complete dust, fume, and mist, and gas, vapor, or gas and vapor chemical cartridge respirators shall not exceed the maximum allowable limits set forth in § 84.1157(a)(2).