[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)] [Notices] [Pages 38910-38920] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2014-15989] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 036'' (``Recognition List Number: 036''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of the document entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 036'' to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, [[Page 38911]] MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-847-8149. Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. An electronic copy of Recognition List Number: 036 is available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 036 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how we would implement our standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains HTML and PDF versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 036 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. We will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. We will use the term ``Recognition List Number: 036'' to identify these current modifications. In table 1, we describe the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III, we list modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--Modifications to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Replacement recognition Old recognition No. No. Title of standard \1\ Change ---------------------------------------------------------------------------------------------------------------- A. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-58...................... 1-99...................... ASTM G175-13 Standard test Withdrawn and replaced method for evaluating the with newer version. ignition sensitivity and fault tolerance of oxygen pressure regulators used for medical and emergency applications. 1-77...................... 1-100..................... CGA V1:2013 Standard for Withdrawn and replaced compressed gas cylinder valve with newer version. outlet and inlet connections. 1-80...................... 1-101..................... CGA C-9:2013 Standard color Withdrawn and replaced marking of compressed gas with newer version. containers for medical use. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-117..................... .......................... ANSI/AAMI/ISO 10993-3:2003/(R) Reaffirmation. 2013 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. 2-133..................... .......................... ASTM F1408-97 (Reapproved Reaffirmation. 2013) Standard practice for subcutaneous screening test for implant materials. 2-136..................... .......................... ASTM E1262-88 (Reapproved Reaffirmation. 2013) Standard guide for performance of the Chinese hamster ovary cell/ hypoxanthine guanine phosphoribosyl transferase gene mutation assay. 2-141..................... .......................... ASTM F1984-99 (Reapproved Reaffirmation. 2013) Standard practice for testing for whole complement activation in serum by solid materials. 2-145..................... .......................... ASTM F1439-03 (Reapproved Reaffirmation. 2013) Standard guide for performance of lifetime bioassay for the tumorigenic potential of implant materials. 2-146..................... 2-206..................... ASTM F2148-13 Standard Withdrawn and replaced practice for evaluation of with newer version. delayed contact hypersensitivity using the murine local lymph node assay (LLNA). 2-153..................... .......................... ANSI/AAMI/ISO 10993-5:2009/(R) Reaffirmation. 2014 Biological evaluation of medical devices--Part 5: Tests for in vitro cytotoxicity. [[Page 38912]] 2-154..................... 2-207..................... ASTM F756-13 Standard practice Withdrawn and replaced for assessment of hemolytic with newer version. properties of materials. 2-156..................... .......................... ANSI/AAMI/ISO 10993-1:2009/(R) Reaffirmation. 2013 Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. 2-175..................... .......................... ISO 10993-3 Second edition Extent of recognition. 2003-10-15, Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. 2-199..................... 2-208..................... USP 37-NF32:2014 <87> Withdrawn and replaced Biological reactivity test, with newer version. in vitro--direct contact test. 2-200..................... 2-209..................... USP 37-NF32:2014 <87> Withdrawn and replaced Biological reactivity test, with newer version. in vitro--elution test. 2-201..................... 2-210..................... USP 37-NF32:2014 <88> Withdrawn and replaced Biological reactivity test, with newer version. in vivo, procedure preparation of sample. 2-202..................... 2-211..................... USP 37-NF32:2014 <88> Withdrawn and replaced Biological reactivity test, with newer version. in vitro, classification of plastics--intracutaneous test. 2-203..................... 2-212..................... USP 37-NF32:2014 <88> Withdrawn and replaced Biological reactivity test, with newer version. in vivo, classification of plastics--systemic injection test. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-42...................... .......................... ANSI/AAMI EC13:2002/(R)2007 Withdrawn. See 3-101. Cardiac monitors, heart rate meters, and alarm. 3-65...................... .......................... ANSI/AAMI EC38:2007 Medical Withdrawn. See 3-127. electrical equipment--Part 2- 47: Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems. 3-72...................... 3-129..................... ANSI/AAMI EC53:2013 ECG trunk Withdrawn and replaced cables and patient lead wires. with newer version. 3-77...................... .......................... ANSI/AAMI PC69:2007 Active Withdrawn. See 3-128. implantable medical devices-- Electromagnetic compatibility--EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. 3-78...................... 3-130..................... ANSI/AAMI/ISO 80601-2-30:2009 Withdrawn and replaced and A1:2013 Medical with newer version. electrical equipment--Part 2- 30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers [Amendment 1:2013]. 3-79...................... .......................... F2070-09 (Reapproved 2013) Reaffirmation. Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents. 3-82...................... 3-125..................... ISO 5841 Third edition 2013-04- Withdrawn and replaced 15 Implants for surgery-- with newer version. Cardiac pacemakers--Part 3: Low-profile connectors [IS-1] for implantable pacemakers. 3-95...................... 3-126..................... IEC 60601-2-27 Edition 3.0 Withdrawn and replaced 2011-03 Medical electrical with newer version equipment--Part 2-27: including technical Particular requirements for corrigendum. the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]. ---------------------------------------------------------------------------------------------------------------- D. Dental/ENT ---------------------------------------------------------------------------------------------------------------- 4-92...................... .......................... ANSI/ADA Standard No. 88 Reaffirmation. (Reaffirmed 2012) Dental brazing alloys. 4-96...................... .......................... ANSI/ADA Specification No. 30 Reaffirmation. (Reaffirmed 2010) Dental zinc oxide--eugenol and zinc oxide--non-eugenol cements. 4-97...................... .......................... ANSI/ADA Standard No. 57 Reaffirmation. (Reaffirmed 2012) Endodontic sealing materials. 4-149..................... .......................... ANSI/ADA Specification No. 39 Reaffirmation. (Reaffirmed 2011) Pit and fissure sealants. 4-160..................... .......................... ANSI S3.1 (Reaffirmed 2013) Reaffirmation. Maximum permissible ambient noise levels for audiometric test rooms. 4-162..................... .......................... ANSI S3.4-2007 (Reaffirmed Reaffirmation. 2012) Procedure for the computation of loudness of steady sounds. 4-163..................... .......................... ANSI S3.5-1987 (Reaffirmed Reaffirmation. 2012) American national standard methods for calculation of the speech intelligibility index. 4-165..................... .......................... ANSI S3.13-1987 (Reaffirmed Reaffirmation. 2012) American national standard mechanical coupler for measurement of bone vibrators. 4-171..................... .......................... ANSI S3.37-1987 (Reaffirmed Reaffirmation. 2012) American national standard preferred earhook nozzle thread for postauricular hearing aids. 4-175..................... 4-211..................... ANSI S3.46-2013 American Withdrawn and replaced national standard method of with newer version. measurement of real-ear performance characteristics of hearing aids. 4-177..................... .......................... ANSI S12.65-2006 (Reaffirmed Reaffirmation. 2011) American national standard for rating noise with respect to speech interference. [[Page 38913]] 4-179..................... 4-212..................... ISO 7405 Second edition 2008- Withdrawn and replaced 12-15 Dentistry--Evaluation with newer version of biocompatibility of including amendment. medical devices used in dentistry [Including: Amendment 1 (2013)]. 4-193..................... .......................... ANSI/ADA Standard No. 15 Reaffirmation. (Reaffirmed 2013) Artificial teeth for dental prostheses. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management (QS/RM)) ---------------------------------------------------------------------------------------------------------------- 5-22...................... .......................... ISO 2768-l First edition 1999- Withdrawn. 11-15 General tolerances-- Part 1: Tolerances for linear and angular dimensions without individual tolerance indications. 5-23...................... .......................... ISO 2768-2 First edition 1989- Withdrawn. 11-15 General tolerances-- Part 2: Geometrical tolerances for features without individual tolerance indications. 5-50...................... 5-87...................... IEC 62366 Edition 1.1 2014-01 Withdrawn and replaced Medical devices--Application with newer version. of usability engineering to medical devices. 5-53...................... 19-1...................... IEC 60601-1-2 Edition 3:2007- Transferred to General 03 Medical electrical II (ES/EMC). equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic compatibility--Requirements and tests. 5-54...................... 19-2...................... ANSI/AAMI/IEC 60601-1-2:2007/ Transferred to General (R)2012 Medical electrical II (ES/EMC). equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic compatibility--Requirements and tests. 5-66...................... 19-3...................... IEC 60601-1-10 Edition 1.0 Transferred to General 2007-11 Medical electrical II (ES/EMC). equipment--Part 1-10: General requirements for basic safety and essential performance-- Collateral standard: Requirements for the development of physiologic closed-loop controllers. 5-77...................... 19-4...................... ANSI/AAMI ES60601-1:2005/ Transferred to General (R)2012 and A1:2012,C1:2009/ II (ES/EMC). (R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment--Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005, mod). 5-78...................... 19-5...................... ANSI/AAMI ES60601-1:2005/ Transferred to General (R)2012 and C1:2009/(R)2012 II (ES/EMC). and A2:2010/(R)2012 (consolidated text) Medical electrical equipment--Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005, mod). 5-81...................... 5-88...................... ISO 2859-1 First edition 1999- Withdrawn and replaced 11-15 Sampling procedures for with newer version inspection by attributes-- including amendment. Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Corrigendum 1 (2001), Amendment 1 (2011)]. 5-82...................... 19-6...................... IEC 60601-1-11 Edition 1.0 Transferred to General 2010-04 Medical electrical II (ES/EMC). equipment--Part 1-11: General requirements for basic safety and essential performance-- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [including: Technical corrigendum 1 (2011)]. 5-83...................... 19-7...................... ANSI/AAMI HA60601-1-11:2011 Transferred to General Medical electrical equipment-- II (ES/EMC). Part 1-11: General requirements for basic safety and essential performance-- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1- 11:2010 mod). 5-85...................... .......................... IEC 60601-1-6 Edition 3.0 2010- Transition period added. 01 Medical electrical equipment--Part 1-6: General requirements for basic safety and essential performance-- Collateral standard: Usability. 5-73...................... 5-90...................... ISO 15223-1 Second edition Extent of recognition. 2012-07-01 Medical devices-- Symbols to be used with medical device labels, labeling, and information to be supplied--Part 1: General requirements. 5-75...................... 5-91...................... AAMI/ANSI/ISO 15223-1:2012 Extent of recognition. Medical devices--Symbols to be used with medical devices labels, labeling, and information to be supplied-- Part 1: General requirements. 5-57...................... .......................... AAMI/ANSI HE75:2009 Human Relevant guidance. factors engineering--Design of medical devices. 5-67...................... .......................... ANSI/AAMI/IEC 62366:2007/ Relevant guidance. (R)2013 Medical devices-- Application of usability engineering to medical devices. ---------------------------------------------------------------------------------------------------------------- F. General Hospital/General Plastic Surgery ---------------------------------------------------------------------------------------------------------------- 6-180..................... .......................... ASTM F2407-06 (Reapproved Reaffirmation. 2013) Standard specification for surgical gowns intended for use in healthcare facilities. [[Page 38914]] 6-184..................... 6-323..................... ASTM F1862/F1862M-13 Standard Withdrawn and replaced test method for resistance of with newer version. medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity). 6-234..................... 6-324..................... IEC 60601-2-50 Edition 2.0 Withdrawn and replaced 2009-03 Medical electrical with newer version equipment--Part 2-50: including technical Particular requirements for corrigendum. the basic safety and essential performance of infant phototherapy equipment [Including: Technical corrigendum 1 (2010)]. 6-300..................... 6-325..................... IEC 60601-2-21 Edition 2.0 Withdrawn and replaced 2009-02 Medical electrical with newer version equipment--Part 2-21: including technical Particular requirements for corrigendum. the basic safety and essential performance of infant radiant warmers [Including: Technical corrigendum 1 (2013)]. 6-309..................... 6-326..................... USP 37-NF 33:2014 Sodium Withdrawn and replaced chloride irrigation. with newer version. 6-310..................... 6-327..................... USP 37-NF 33:2014 Sodium Withdrawn and replaced chloride injection. with newer version. 6-311..................... 6-328..................... USP 37-NF 33:2014 Withdrawn and replaced Nonabsorbable surgical suture. with newer version. 6-312..................... 6-329..................... USP 37-NF 33:2014 <881> Withdrawn and replaced Tensile strength. with newer version. 6-313..................... 6-330..................... USP 37-NF 33:2014 <861> Withdrawn and replaced Sutures--Diameter. with newer version. 6-314..................... 6-331..................... USP 37-NF 33:2014 <871> Withdrawn and replaced Sutures--Needle attachment. with newer version. 6-315..................... 6-332..................... USP 37-NF 33:2014 Sterile Withdrawn and replaced water for irrigation. with newer version. 6-316..................... 6-333..................... USP 37-NF 33:2014 Heparin lock Withdrawn and replaced flush solution. with newer version. 6-317..................... 6-334..................... USP 37-NF 33:2014 Absorbable Withdrawn and replaced surgical suture. with newer version. ---------------------------------------------------------------------------------------------------------------- G. In Vitro Diagnostics ---------------------------------------------------------------------------------------------------------------- 7-48...................... .......................... CLSI C60-A (Formerly T/DM06-A) Designation number. Blood alcohol testing in the clinical laboratory; Approved guideline. 7-112..................... .......................... CLSI POCT14-A (Formerly H49-A) Designation number. Point-of-care monitoring of anticoagulation therapy; Approved guideline. 7-133..................... 7-246..................... CLSI POCT12-A3 Point-of-care Withdrawn and replaced blood glucose testing in with newer version. acute and chronic care facilities; Approved guideline--Third edition. 7-142..................... .......................... CLSI GP43-A4 (Replaces H11-A4) Designation number. Procedures for the collection of arterial blood specimens; Approved standard--Fourth edition. 7-162..................... .......................... CLSI POCT14-A (Formerly H49-A) Designation number. Point-of-care monitoring of anticoagulation therapy; Approved guideline. 7-175..................... .......................... CLSI C59-A (Formerly I/LA15-A) Designation number. Apolipoprotein immunoassays: Development and recommended performance characteristics; Approved guideline. 7-201..................... .......................... CLSI GP41-A6 (Replaces H03-A6) Designation number. Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard--Sixth edition. 7-203..................... .......................... CLSI GP42-A6 (Replaces H04-A6) Designation number. Procedures and devices for the collection of diagnostic capillary blood specimens; Approved standard--Sixth edition. 7-213..................... .......................... CLSI GP44-A4 (Replaces H18-A4) Designation number. Procedures for the handling and processing of blood specimens for common laboratory tests; Approved guideline--Fourth edition. 7-221..................... .......................... CLSI GP39-A6 (Replaces H01-A6) Designation number. Tubes and additives for venous and capillary blood specimen collection; Approved standard--Sixth edition. 7-241..................... 7-247..................... CLSI M100-S24 Performance Withdrawn and replaced standards for antimicrobial with newer version. susceptibility testing; Twenty-fourth informational supplement. ---------------------------------------------------------------------------------------------------------------- H. Materials ---------------------------------------------------------------------------------------------------------------- 8-173..................... 8-371..................... ASTM F601-13 Standard practice Withdrawn and replaced for fluorescent penetrant with newer version. inspection of metallic surgical implants. 8-183..................... 8-372..................... ASTM F560-13 Standard Withdrawn and replaced specification for unalloyed with newer version. tantalum for surgical implant applications (UNS R05200, UNS R05400). 8-193..................... .......................... ASTM F2754/F2754M-09 Reaffirmation. (Reapproved 2013) Standard test method for measurement of camber, cast, helix, and direction of helix of coiled wire. [[Page 38915]] 8-198..................... 8-373..................... ASTM F2102-13 Standard guide Withdrawn and replaced for evaluating the extent of with newer version. oxidation in polyethylene fabricated forms intended for surgical implants. 8-199..................... 8-374..................... ASTM F2633-13 Standard Withdrawn and replaced specification for wrought with newer version. seamless nickel-titanium shape memory alloy tube for medical devices and surgical implants. 8-221..................... 8-375..................... ASTM F2066-13 Standard Withdrawn and replaced specification for wrought with newer version. titanium-15 molybdenum alloy for surgical implant applications (UNS R58150). 8-224..................... 8-376..................... ASTM F2102-13 Standard guide Withdrawn and replaced for evaluating the extent of with newer version. oxidation in polyethylene fabricated forms intended for surgical implants. 8-341..................... 8-377..................... ASTM F136-13 Standard Withdrawn and replaced specification for wrought with newer version. titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401). 8-364..................... 8-378..................... ASTM D792-13 Standard test Withdrawn and replaced methods for density and with newer version. specific gravity (relative density) of plastics by displacement. 8-366..................... 8-379..................... ISO 11542-2 First edition 1998- Withdrawn and replaced 11-15 Plastics--Ultra-high- with newer version molecular-weight polyethylene including technical (PE-UHMW) moulding and corrigendum. extrusion materials--Part 2: Preparation of test specimens and determination of properties [Including: Technical corrigendum 1 (2007)]. ---------------------------------------------------------------------------------------------------------------- I. Nanotechnology ---------------------------------------------------------------------------------------------------------------- 18-2...................... .......................... ASTM E2535-07 (Reapproved Reaffirmation. 2013) Standard guide for handling unbound engineered nanoscale particles in occupational settings. ---------------------------------------------------------------------------------------------------------------- J. Neurology ---------------------------------------------------------------------------------------------------------------- 17-10..................... .......................... ANSI/AAMI/ISO 14708-3:2008/ Reaffirmation. (R)2011 Implants for surgery-- Active implantable medical devices--Part 3: Implantable neurostimulators. ---------------------------------------------------------------------------------------------------------------- K. OB-GYN/Gastroenterology/Urology ---------------------------------------------------------------------------------------------------------------- 9-44...................... .......................... ASTM F623-99 (Reapproved 2013) Reaffirmation. Standard performance specification for Foley catheter. 9-87...................... 9-93...................... ISO 25841 Second edition 2014- Withdrawn and replaced 01-15 Female condoms-- with newer version. Requirements and test methods. 9-21...................... 9-94...................... ISO 8600-4 Second edition 2014- Withdrawn and replaced 03-15 Optics and optical with newer version. instruments--Medical endoscopes and certain accessories--Part 4: Determination of maximum width of insertion portion. ---------------------------------------------------------------------------------------------------------------- L. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-211.................... 11-276.................... ASTM F1798-13 Standard test Withdrawn and replaced method for evaluating the with newer version. static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants. 11-237.................... 11-277.................... ISO 7206-6 Second edition 2013- Withdrawn and replaced 11-15 Implants for surgery-- with newer version. Partial and total hip joint prostheses--Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components. 11-255.................... 11-278.................... ASTM F1717-14 Standard test Withdrawn and replaced methods for spinal implant with newer version. constructs in a vertebrectomy model. ---------------------------------------------------------------------------------------------------------------- M. Radiology ---------------------------------------------------------------------------------------------------------------- 12-23..................... .......................... NEMA XR 10-1986 (R1992, R1998, Withdrawn. R2003) Measurement of the maximum symmetrical radiation field from a rotating anode x- ray tube used for medical diagnosis. 12-24..................... .......................... NEMA XR 11-1993 (R1999) Test Withdrawn. standard for determination of the limiting spatial resolution of x-ray image intensifier systems. 12-25..................... .......................... NEMA XR 15-1991 (R1996, R2001) Withdrawn. Test standard for the determination of the visible entrance field size of an x- ray image intensifier system. 12-26..................... .......................... NEMA XR 16-1991 (R1996, R2001) Withdrawn. Test standard for the determination of the system contrast ratio and the system veiling glare index of an x- ray image intensifier system. 12-27..................... .......................... NEMA XR 17-1993 (R1999) Test Withdrawn. standard for the measurement of the image signal uniformity of an x-ray image intensifier system. [[Page 38916]] 12-28..................... .......................... NEMA XR 18-1993 (R1999) Test Withdrawn. standard for the determination of the radial image distortion of an x-ray image intensifier system. 12-29..................... .......................... NEMA XR 19-1993 (R1999) Withdrawn. Electrical, thermal, and loading characteristics of x- ray tubes used for medical diagnosis. 12-66..................... 12-271.................... AIUM MUS Medical ultrasound Withdrawn and replaced safety, third edition. with newer version. 12-79..................... .......................... NEMA XR7-1995 (R2000) High- Withdrawn. voltage x-ray cable assemblies and receptacles. 12-80..................... .......................... NEMA XR 9-1984 (R1994, R2000) Withdrawn. Power supply guidelines for x- ray machines. 12-81..................... .......................... NEMA XR 13-1990 (R1995, R2000) Withdrawn. Mechanical safety standard for power driven motions of electromedical equipment. 12-82..................... .......................... NEMA XR 14-1990 (R1995, R2000) Withdrawn. Recommended practices for load bearing mechanical assemblies used in diagnostic imaging. 12-100.................... .......................... NEMA UD 3-2004 (R2009) Withdrawn Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. 12-146.................... 12-272.................... IEC 60601-2-17 Edition 3.0 Withdrawn and replaced 2013-11 Medical electrical with newer version. equipment--Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment. 12-168.................... 12-273.................... IEC 60825-1 Edition 2.0 2007- Withdrawn and replaced 03 Safety of laser products-- with newer version Part 1: Equipment including technical classification and corrigendum and requirements [Including: interpretation sheets. Technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. 12-193.................... .......................... AIUM AOL 2008 Acoustic output Withdrawn. labeling standard for diagnostic ultrasound equipment revision 1--A standard for how manufacturers should specify acoustic output data. 12-194.................... .......................... ANSI/HPS N43.6-2007 (R2013) Reaffirmation. Sealed radioactive sources-- Classification. 12-201.................... 12-274.................... IEC 60601-2-54 Edition 1.0 Withdrawn and replaced 2009-06 Medical electrical with newer version equipment--Part 2-54: including technical Particular requirements for corrigendum. the basic safety and essential performance of x- ray equipment for radiography and radioscopy [Including: Technical corrigendum 1 (2010), technical corrigendum 2 (2011)]. 12-220.................... .......................... IEC 60825-1 (Second edition- Withdrawn. See 12-273. 2007) Safety of laser products--Part 1: Equipment classification and requirements corrigendum 1. 12-239.................... .......................... IEC 60825-1 (Second edition- Withdrawn. See 12-273. 2007) I-SH 01 Safety of laser products--Part 1: Equipment classification and requirements, interpretation sheet 1. 12-240.................... .......................... IEC 60825-1 (2007) Second Withdrawn. See 12-273. edition, I-SH 02 Safety of laser products--Part 1: Equipment classification and requirements, interpretation sheet 2. ---------------------------------------------------------------------------------------------------------------- N. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-4...................... 13-65..................... ANSI/UL 1998 Third edition Withdrawn and replaced 2013 Standard for software in with newer version. programmable components. 13-15..................... .......................... CLSI AUTO13-A2 Laboratory New designation number. instruments and data management systems: Design of software user interfaces and end-user software systems validation, operation, and monitoring; Approved guideline--second edition. 13-46..................... .......................... ASTM F2761-09 (2013) Medical Reaffirmation. devices and medical systems-- Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)-- Part 1: General requirements and conceptual model. 13-58..................... 13-66..................... ISO/IEEE 11073-10417 First Withdrawn and replaced edition 2014-03-01 Health with newer version. informatics--Personal health device communication--Part 10417: Device specialization: Glucose meter. ---------------------------------------------------------------------------------------------------------------- O. Sterility ---------------------------------------------------------------------------------------------------------------- 14-181.................... 14-432.................... ANSI/AAMI ST58:2013 Chemical Withdrawn and replaced sterilization and high-level with newer version. disinfection in health care facilities. 14-228.................... .......................... ANSI/AAMI/ISO 11135-1:2007 Withdrawn. See 14-452. Sterilization of healthcare products--Ethylene oxide-- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. [[Page 38917]] 14-232.................... 14-433.................... ASTM F2227-13 Standard test Withdrawn and replaced method for non-destructive with newer version. detection of leaks in non- sealed and empty packaging trays by CO2 tracer gas method. 14-233.................... 14-434.................... ASTM F2228-13 Standard test Withdrawn and replaced method for non-destructive with newer version. detection of leaks in packaging which incorporates porous barrier material by CO2 tracer gas method. 14-256.................... .......................... ASTM F2095-07 (Reapproved Reaffirmation. 2013) Standard test methods for pressure decay leak test for flexible packages with and without restraining plates. 14-257.................... .......................... ASTM D3078-02 (Reapproved Reaffirmation. 2013) Standard test method for determination of leaks in flexible packaging by bubble emission. 14-259.................... 14-435.................... ASTM F2251-13 Standard test Withdrawn and replaced method for thickness with newer version. measurement of flexible packaging material. 14-261.................... .......................... ANSI/AAMI/ISO 17665-1:2006/ Reaffirmation. (R)2013 Sterilization of health care products--Moist heat--Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-282.................... .......................... ASTM F2338-09 (Reapproved Reaffirmation. 2013) Standard test method for nondestructive detection of leaks in packages by vacuum decay method. 14-286.................... .......................... ANSI/AAMI ST65:2008/(R)2013 Reaffirmation. Processing of reusable surgical textiles for use in health care facilities. 14-288.................... .......................... ASTM F1886/F1886M-09 Reaffirmation. (Reapproved 2013) Standard test method for determining integrity of seals for flexible packaging by visual inspection. 14-290.................... .......................... ANSI/AAMI ST24:1999/(R)2013 Reaffirmation. Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities. 14-291.................... .......................... ANSI/AAMI/ISO 14937:2009/ Reaffirmation. (R)2013 Sterilization of healthcare products--General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices. 14-331.................... 14-452.................... ISO 11135 Second edition 2014 Withdrawn and replaced Sterilization of healthcare with newer version. products--Ethylene oxide-- Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-342.................... .......................... ASTM E2628-09 (E2009) Standard Withdrawn. See 14-436. practice for dosimetry in radiation. 13-343.................... .......................... ASTM E2701-09 Standard guide Withdrawn. See 14-437. for performance characterization of dosimeters and dosimetry systems for use in radiation processing. 14-348.................... .......................... ANSI/AAMI/ISO 13408-2:2003/ Reaffirmation. (R)2013 Aseptic processing of healthcare products--Part 2: Filtration. 14-364.................... 14-438.................... ANSI/AAMI/ISO 11137-2:2013 Withdrawn and replaced Sterilization of health care with newer version. products--Radiation--Part 2: Establishing the sterilization dose. 14-394.................... 14-439.................... ANSI/AAMI ST79:2010, A1:2010, Withdrawn and replaced A2:2011, A3:2012, and A4:2013 with newer version. (consolidated text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 14-414.................... 14-440.................... USP 37NF32:2014 Withdrawn and replaced Microbiological examination with newer version. of nonsterile products: Microbial enumeration tests. 14-415.................... 14-441.................... USP 37NF32:2014 Sterility Withdrawn and replaced tests. with newer version. 14-416.................... 14-442.................... USP 37NF32:2014 Bacterial Withdrawn and replaced endotoxins test. with newer version. 14-417.................... 14-443.................... USP 37NF32:2014 Pyrogen test Withdrawn and replaced (USP rabbit test). with newer version. 14-418.................... 14-444.................... USP 37NF32:2014 Transfusion Withdrawn and replaced and infusion assemblies and with newer version. similar medical devices. 14-419.................... 14-445.................... USP 37NF32:2014 Biological Withdrawn and replaced indicator for steam with newer version. sterilization--Self-contained. 14-420.................... 14-446.................... USP 37NF32:2014 Biological Withdrawn and replaced indicator for dry-heat with newer version. sterilization, paper carrier. 14-421.................... 14-447.................... USP 37NF32:2014 Biological Withdrawn and replaced indicator for ethylene oxide with newer version. sterilization, paper carrier. 14-422.................... 14-448.................... USP 37NF32:2014 Biological Withdrawn and replaced indicator for steam with newer version. sterilization, paper carrier. 14-423.................... 14-449.................... USP 37NF32:2014 Withdrawn and replaced Microbiological examination with newer version. of nonsterile products: Tests for specified microorganisms. [[Page 38918]] 14-425.................... .......................... ANSI/AAMI/ISO 13408-6:2005/ Reaffirmation. (R)2013 and A1:2013 Aseptic processing of healthcare products--Part 6: Isolator systems. ---------------------------------------------------------------------------------------------------------------- P. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-21..................... 15-39..................... ASTM F2150-13 Standard guide Withdrawn and replaced for characterization and with newer version. testing of biomaterial scaffolds used in tissue- engineered medical products(TEMPs). 15-26..................... 15-40..................... ASTM F2211-13 Standard Withdrawn and replaced classification for tissue- with newer version. engineered medical products (TEMPs). 15-33..................... 15-41..................... ASTM F2602-13 Standard test Withdrawn and replaced method for determining the with newer version. molar mass of chitosan and chitosan salts by size exclusion chromatography with multi-angle light scattering detection (SEC-MALS). ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2, we provide the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 036. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and date ------------------------------------------------------------------------ A. Cardiovascular ------------------------------------------------------------------------ 3-127....................... Medical electrical ANSI/AAMI/IEC equipment--Part 2-47: 60601-2-47:201 Particular requirements 2. for the basic safety and essential performance of ambulatory electrocardiographic systems. 3-128....................... Active implantable ANSI/AAMI/ISO medical devices-- 14117:2012. Electromagnetic compatibility--EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices. ------------------------------------------------------------------------ B. General I (Quality System/Risk Management (QS/RM)) ------------------------------------------------------------------------ 5-89........................ Medical electrical IEC 60601-1-6 equipment--Part 1-6: Edition 3.1 General requirements for 2013-10. basic safety and essential performance-- Collateral standard: Usability. 5-92........................ Medical Electrical ANSI/AAMI/IEC Equipment--Part 1-8: 60601-1-8:2006 General requirements for & A1:2012. basic safety and essential performance-- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. ------------------------------------------------------------------------ C. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC)) ------------------------------------------------------------------------ 19-1........................ Medical electrical IEC 60601-1-2 equipment--Part 1-2: Edition 3:2007- General requirements for 03. basic safety and essential performance-- Collateral standard: electromagnetic compatibility--requireme nts and tests. 19-2........................ Medical electrical ANSI/AAMI/IEC equipment--Part 1-2: 60601-1-2:2007/ General requirements for (R)2012. basic safety and essential performance-- Collateral standard: electromagnetic compatibility--requireme nts and tests. 19-3........................ Medical electrical IEC 60601-1-10 equipment--Part 1-10: Edition General requirements for 1.0:2007-11. basic safety and essential performance-- Collateral standard: requirements for the development of physiologic closed-loop controllers. 19-4........................ Medical electrical ANSI/AAMI equipment--Part 1: ES60601-1:2005/ General requirements for (R)2012 and basic safety and A1:2012,C1:200 essential performance 9/(R)2012 and (IEC 60601-1:2005, mod). A2:2010/ (R)2012. 19-5........................ Medical electrical ANSI/AAMI equipment--Part 1: ES60601-1:2005/ General requirements for (R)2012 and basic safety and C1:2009/ essential performance (R)2012 and, (IEC 60601-1:2005, mod). A2:2010/ (R)2012 (Consolidated text). 19-6........................ Medical electrical IEC 60601-1-11 equipment--Part 1-11: Edition General requirements for 1.0:2010-04. basic safety and essential performance-- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: Technical corrigendum 1 (2011)]. 19-7........................ Medical electrical ANSI/AAMI equipment--Part 1-11: HA60601-1-11:2 General requirements for 011. basic safety and essential performance-- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010 mod). [[Page 38919]] 19-8........................ Medical electrical IEC 60601-1-2 equipment--Part 1-2: Edition General requirements for 4.0:2014-02. basic safety and essential performance-- Collateral standard: Electromagnetic disturbances--Requiremen ts and tests. 19-9........................ Medical electrical IEC 60601-1-10 equipment--Part 1-10: Edition General requirements for 1.1:2013-11. basic safety and essential performance-- Collateral standard: Requirements for the development of physiologic closed-loop controllers. 19-10....................... Lithium batteries........ UL 1642 5th Edition 2013. 19-11....................... Household and commercial UL 2054 2nd batteries. Edition 2011. ------------------------------------------------------------------------ D. Orthopedics ------------------------------------------------------------------------ 11-279...................... Standard practice for ASTM F2996-13. finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems. 11-280...................... Standard test method for ASTM F2624-12. static, dynamic, and wear assessment of extra- discal single level spinal constructs. ------------------------------------------------------------------------ E. Radiology ------------------------------------------------------------------------ 12-275...................... Ultrasonics--Power IEC 61161 measurement--Radiation Edition force balances and 3.0:2013-01. performance requirements. 12-276...................... Ultrasonics--Output test-- IEC TS 62462 Guide for the First edition maintenance of 2007-05. ultrasound physiotherapy systems. 12-277...................... Ultrasonics--Hydrophones- IEC 62127-1 -Part 1: Measurement and Edition characterization of 1.1:2013-02. medical ultrasonic fields up to 40 megahertz (MHz). 12-278...................... Ultrasonics--Hydrophones- IEC 62127-2 -Part 2: Calibration for Edition ultrasonic fields up to 1.0:2007-08. 40 MHz (including corrigendum 1:2008 and amendment 1:2013). 12-279...................... Ultrasonics--Hydrophones- IEC 62127-3 -Part 3: Properties of Edition hydrophones for 1.1:2013-05. ultrasonic fields up to 40 MHz. 12-280...................... Ultrasonics--Power IEC 62555 measurement--High Edition intensity therapeutic 1.0:2013-11. ultrasound (HITU) transducers and systems. 12-281...................... Medical electrical IEC 60601-2-62 equipment--Part 2-62: Edition Particular requirements 1.0:2013-07. for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment. 12-282...................... Eyewear for protection ISO 12609-1 against intense light First edition sources used on humans 2013-07-15. and animals for cosmetic and medical applications--Part 1: Specification for products. 12-283...................... Eyewear for protection ISO 12609-2 against intense light First edition sources used on humans 2013-07-15. and animals for cosmetic and medical applications--Part 2: Guidance for use. ------------------------------------------------------------------------ F. Software/Informatics ------------------------------------------------------------------------ 13-67....................... Health informatics-- ISO/IEEE 11073- Personal health device 10418 First communication--Part edition 2014- 10418: Device 03-01. specialization--Internat ional normalized ratio (INR) monitor. 13-68....................... Health informatics--Point- ISO 11073-90101 of-care medical device First edition communication--Part 2008-01-15. 90101: Analytical instruments--Point-of- care test. 13-69....................... Health Informatics-- ISO/IEEE 11073- Personal health device 10472 First communication--Part edition 2012- 10472: Device 11-01. specialization--Medicati on monitor. ------------------------------------------------------------------------ G. Sterility ------------------------------------------------------------------------ 14-436...................... Practice for dosimetry in ISO/ASTM 52628 radiation processing. First edition 2013-11-15. 14-437...................... Guide for performance ISO/ASTM 52701 characterization of First edition dosimeters and dosimetry 2013-11-15. systems for use in radiation processing. 14-450...................... Biological indicators-- USP 37- Resistance performance NF32:2014 tests. <55>. 14-451...................... Biological indicators for USP 37- sterilization. NF32:2014 <1035>. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at our Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. We will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with Recognition List 033, we will no longer announce minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for [[Page 38920]] recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to www.[email protected]. To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards-related documents. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 036'' will be available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access the CDRH home page at http://www.fda.gov/MedicalDevices. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for ``FDA Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards. VII. Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 036. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: July 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014-15989 Filed 7-8-14; 8:45 am] BILLING CODE 4164-01-P