Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036
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Notice.
Citation: "79 FR 38910"
Document Number: "Docket No.
"Notices"
SUMMARY:
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
Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION: 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
In a notice published in the
Modifications to the initial list of recognized standards, as published in the
These notices describe the addition, withdrawal, and revision of certain standards recognized by
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
In section III, we list modifications the Agency is making that involve the initial addition of standards not previously recognized by
Table 1--Modifications to the List of Recognized Standards Old Replacement Title of standard *1 Change recognition recognition No. No. 1-58 1-99 ASTM G175-13 Standard test Withdrawn and method for evaluating the replaced with ignition sensitivity and newer version. fault tolerance of oxygen pressure regulators used for medical and emergency applications 1-77 1-100 CGA V1:2013 Standard for Withdrawn and compressed gas cylinder replaced with valve outlet and inlet newer version. connections 1-80 1-101 CGA C-9:2013 Standard Withdrawn and color marking of replaced with compressed gas containers newer version. for medical use B. Biocompatibility 2-117 ANSI/AAMI/ISO 10993- Reaffirmation. 3:2003/(R) 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 practice for evaluation of replaced with delayed contact newer version. hypersensitivity using the murine local lymph node assay (LLNA) 2-153 ANSI/AAMI/ISO 10993- Reaffirmation. 5:2009/(R) 2014 Biological evaluation of medical devices--Part 5: Tests for in vitro cytotoxicity 2-154 2-207 ASTM F756-13 Standard Withdrawn and practice for assessment of replaced with hemolytic properties of newer version. materials 2-156 ANSI/AAMI/ISO 10993- Reaffirmation. 1:2009/(R) 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 2003-10-15, Biological recognition. evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity 2-199 2-208 USP 37-NF32:2014 <87> Withdrawn and Biological reactivity replaced with test, in vitro--direct newer version. contact test 2-200 2-209 USP 37-NF32:2014 <87> Withdrawn and Biological reactivity replaced with test, in vitro--elution newer version. test 2-201 2-210 USP 37-NF32:2014 <88> Withdrawn and Biological reactivity replaced with test, in vivo, procedure newer version. preparation of sample 2-202 2-211 USP 37-NF32:2014 <88> Withdrawn and Biological reactivity replaced with test, in vitro, newer version. classification of plastics--intracutaneous test 2-203 2-212 USP 37-NF32:2014 <88> Withdrawn and Biological reactivity replaced with test, in vivo, newer version. classification of plastics--systemic injection test 3-42 ANSI/AAMI Withdrawn. See EC13:2002/(R)2007 Cardiac 3-101. monitors, heart rate meters, and alarm 3-65 ANSI/AAMI EC38:2007 Withdrawn. See Medical electrical 3-127. 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 Withdrawn and trunk cables and patient replaced with lead wires newer version. 3-77 ANSI/AAMI PC69:2007 Active Withdrawn. See implantable medical 3-128. devices--Electromagnetic compatibility--EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators 3-78 3-130 ANSI/AAMI/ISO 80601-2- Withdrawn and 30:2009 and A1:2013 replaced with Medical electrical newer version. 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 Withdrawn and 2013-04-15 Implants for replaced with surgery--Cardiac newer version. pacemakers--Part 3: Low- profile connectors [IS- 1] for implantable pacemakers 3-95 3-126 IEC 60601-2-27 Edition 3.0 Withdrawn and 2011-03 Medical electrical replaced with equipment--Part 2-27: newer version Particular requirements including for the basic safety and technical essential performance of corrigendum. electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)] 4-92 ANSI/ADA Standard No. 88 Reaffirmation. (Reaffirmed 2012) Dental brazing alloys 4-96 ANSI/ADA Specification No. Reaffirmation. 30 (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. Reaffirmation. 39 (Reaffirmed 2011) Pit and fissure sealants 4-160 ANSI S3.1 (Reaffirmed Reaffirmation. 2013) 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 Reaffirmation. (Reaffirmed 2012) American national standard mechanical coupler for measurement of bone vibrators 4-171 ANSI S3.37-1987 Reaffirmation. (Reaffirmed 2012) American national standard preferred earhook nozzle thread for postauricular hearing aids 4-175 4-211 ANSI S3.46-2013 American Withdrawn and national standard method replaced with of measurement of real-ear newer version. performance characteristics of hearing aids 4-177 ANSI S12.65-2006 Reaffirmation. (Reaffirmed 2011) American national standard for rating noise with respect to speech interference 4-179 4-212 ISO 7405 Second edition Withdrawn and 2008-12-15 Dentistry-- replaced with Evaluation of newer version biocompatibility of including medical devices used in amendment. dentistry [Including: Amendment 1 (2013)] 4-193 ANSI/ADA Standard No. 15 Reaffirmation. (Reaffirmed 2013) Artificial teeth for dental prosthesesE. General I (Quality Systems /Risk Management (QS/RM)) 5-22 ISO 2768-l First edition Withdrawn. 1999-11-15 General tolerances--Part 1: Tolerances for linear and angular dimensions without individual tolerance indications 5-23 ISO 2768-2 First edition Withdrawn. 1989-11-15 General tolerances--Part 2: Geometrical tolerances for features without individual tolerance indications 5-50 5-87 IEC 62366 Edition 1.1 Withdrawn and 2014-01 Medical devices-- replaced with Application of usability newer version. engineering to medical devices 5-53 19-1 IEC 60601-1-2 Edition Transferred to 3:2007-03 Medical General II electrical equipment--Part (ES/EMC). 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- Transferred to 2:2007/(R)2012 Medical General II electrical equipment--Part (ES/EMC). 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 2007-11 Medical electrical General II equipment--Part 1-10: (ES/EMC). 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- Transferred to 1:2005/(R)2012 and General II A1:2012,C1:2009/(R)2012 (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) 5-78 19-5 ANSI/AAMI ES60601- Transferred to 1:2005/(R)2012 and General II C1:2009/(R)2012 and (ES/EMC). 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 Withdrawn and 1999-11-15 Sampling replaced with procedures for inspection newer version by attributes--Part 1: including Sampling schemes indexed amendment. 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 2010-04 Medical electrical General II equipment--Part 1-11: (ES/EMC). 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- Transferred to 11:2011 Medical electrical General II equipment--Part 1-11: (ES/EMC). 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 Transition 2010-01 Medical electrical period added. 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 2012-07-01 Medical recognition. 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 Medical devices--Symbols recognition. 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 factors engineering-- guidance. Design of medical devices 5-67 ANSI/AAMI/IEC Relevant 62366:2007/(R)2013 Medical guidance. devices--Application of usability engineering to medical devicesF. General Hospital /General Plastic Surgery 6-180 ASTM F2407-06 (Reapproved Reaffirmation. 2013) Standard specification for surgical gowns intended for use in healthcare facilities 6-184 6-323 ASTM F1862/F1862M-13 Withdrawn and Standard test method for replaced with resistance of medical face newer version. 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 2009-03 Medical electrical replaced with equipment--Part 2-50: newer version Particular requirements including for the basic safety and technical essential performance of corrigendum. infant phototherapy equipment [Including: Technical corrigendum 1 (2010)] 6-300 6-325 IEC 60601-2-21 Edition 2.0 Withdrawn and 2009-02 Medical electrical replaced with equipment--Part 2-21: newer version Particular requirements including for the basic safety and technical essential performance of corrigendum. infant radiant warmers [Including: Technical corrigendum 1 (2013)] 6-309 6-326 USP 37-NF 33:2014 Sodium Withdrawn and chloride irrigation replaced with newer version. 6-310 6-327 USP 37-NF 33:2014 Sodium Withdrawn and chloride injection replaced with newer version. 6-311 6-328 USP 37-NF 33:2014 Withdrawn and Nonabsorbable surgical replaced with suture newer version. 6-312 6-329 USP 37-NF 33:2014 <881> Withdrawn and Tensile strength replaced with newer version. 6-313 6-330 USP 37-NF 33:2014 <861> Withdrawn and Sutures--Diameter replaced with newer version. 6-314 6-331 USP 37-NF 33:2014 <871> Withdrawn and Sutures--Needle attachment replaced with newer version. 6-315 6-332 USP 37-NF 33:2014 Sterile Withdrawn and water for irrigation replaced with newer version. 6-316 6-333 USP 37-NF 33:2014 Heparin Withdrawn and lock flush solution replaced with newer version. 6-317 6-334 USP 37-NF 33:2014 Withdrawn and Absorbable surgical suture replaced with newer version.G. In Vitro Diagnostics 7-48 CLSI C60-A (Formerly Designation T/DM06-A) Blood alcohol number. testing in the clinical laboratory; Approved guideline 7-112 CLSI POCT14-A (Formerly Designation H49-A) Point-of-care number. monitoring of anticoagulation therapy; Approved guideline 7-133 7-246 CLSI POCT12-A3 Point-of- Withdrawn and care blood glucose testing replaced with in acute and chronic care newer version. facilities; Approved guideline--Third edition 7-142 CLSI GP43-A4 (Replaces Designation H11-A4) Procedures for the number. collection of arterial blood specimens; Approved standard--Fourth edition 7-162 CLSI POCT14-A (Formerly Designation H49-A) Point-of-care number. monitoring of anticoagulation therapy; Approved guideline 7-175 CLSI C59-A (Formerly Designation I/LA15-A) Apolipoprotein number. immunoassays: Development and recommended performance characteristics; Approved guideline 7-201 CLSI GP41-A6 (Replaces Designation H03-A6) Procedures for the number. collection of diagnostic blood specimens by venipuncture; Approved standard--Sixth edition 7-203 CLSI GP42-A6 (Replaces Designation H04-A6) Procedures and number. devices for the collection of diagnostic capillary blood specimens; Approved standard--Sixth edition 7-213 CLSI GP44-A4 (Replaces Designation H18-A4) Procedures for the number. handling and processing of blood specimens for common laboratory tests; Approved guideline--Fourth edition 7-221 CLSI GP39-A6 (Replaces Designation H01-A6) Tubes and number. additives for venous and capillary blood specimen collection; Approved standard--Sixth edition 7-241 7-247 CLSI M100-S24 Performance Withdrawn and standards for replaced with antimicrobial newer version. susceptibility testing; Twenty-fourth informational supplement 8-173 8-371 ASTM F601-13 Standard Withdrawn and practice for fluorescent replaced with penetrant inspection of newer version. metallic surgical implants 8-183 8-372 ASTM F560-13 Standard Withdrawn and specification for replaced with unalloyed tantalum for newer version. 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 8-198 8-373 ASTM F2102-13 Standard Withdrawn and guide for evaluating the replaced with extent of oxidation in newer version. polyethylene fabricated forms intended for surgical implants 8-199 8-374 ASTM F2633-13 Standard Withdrawn and specification for wrought replaced with seamless nickel-titanium newer version. shape memory alloy tube for medical devices and surgical implants 8-221 8-375 ASTM F2066-13 Standard Withdrawn and specification for wrought replaced with titanium-15 molybdenum newer version. alloy for surgical implant applications (UNS R58150) 8-224 8-376 ASTM F2102-13 Standard Withdrawn and guide for evaluating the replaced with extent of oxidation in newer version. polyethylene fabricated forms intended for surgical implants 8-341 8-377 ASTM F136-13 Standard Withdrawn and specification for wrought replaced with titanium-6aluminum- newer version. 4vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401) 8-364 8-378 ASTM D792-13 Standard test Withdrawn and methods for density and replaced with specific gravity (relative newer version. density) of plastics by displacement 8-366 8-379 ISO 11542-2 First edition Withdrawn and 1998-11-15 Plastics-- replaced with Ultra-high-molecular- newer version weight polyethylene (PE- including UHMW) moulding and technical extrusion materials--Part corrigendum. 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- Reaffirmation. 3:2008/(R)2011 Implants for surgery--Active implantable medical devices--Part 3: Implantable neurostimulators K. OB-GYN/Gastroenterology/Urology 9-44 ASTM F623-99 (Reapproved Reaffirmation. 2013) Standard performance specification for Foley catheter 9-87 9-93 ISO 25841 Second edition Withdrawn and 2014-01-15 Female replaced with condoms--Requirements and newer version. test methods 9-21 9-94 ISO 8600-4 Second edition Withdrawn and 2014-03-15 Optics and replaced with optical instruments-- newer version. Medical endoscopes and certain accessories--Part 4: Determination of maximum width of insertion portion 11-211 11-276 ASTM F1798-13 Standard Withdrawn and test method for evaluating replaced with the static and fatigue newer version. properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants 11-237 11-277 ISO 7206-6 Second edition Withdrawn and 2013-11-15 Implants for replaced with surgery--Partial and total newer version. 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 Withdrawn and test methods for spinal replaced with implant constructs in a newer version. vertebrectomy model 12-23 NEMA XR 10-1986 (R1992, Withdrawn. R1998, 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) Withdrawn. Test standard for determination of the limiting spatial resolution of x-ray image intensifier systems 12-25 NEMA XR 15-1991 (R1996, Withdrawn. R2001) 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, Withdrawn. R2001) 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) Withdrawn. Test standard for the measurement of the image signal uniformity of an x- ray image intensifier system 12-28 NEMA XR 18-1993 (R1999) Withdrawn. Test 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 Withdrawn and ultrasound safety, third replaced with edition newer version. 12-79 NEMA XR7-1995 (R2000) Withdrawn. High-voltage x-ray cable assemblies and receptacles 12-80 NEMA XR 9-1984 (R1994, Withdrawn. R2000) Power supply guidelines for x-ray machines 12-81 NEMA XR 13-1990 (R1995, Withdrawn. R2000) Mechanical safety standard for power driven motions of electromedical equipment 12-82 NEMA XR 14-1990 (R1995, Withdrawn. R2000) 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 2013-11 Medical electrical replaced with equipment--Part 2-17: newer version. 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 Withdrawn and 2007-03 Safety of laser replaced with products--Part 1: newer version Equipment classification including and requirements technical [Including: Technical corrigendum and corrigendum 1 (2008), interpretation interpretation sheet 1 sheets. (2007), interpretation sheet 2 (2007)] 12-193 AIUM AOL 2008 Acoustic Withdrawn. output 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 Reaffirmation. (R2013) Sealed radioactive sources--Classification 12-201 12-274 IEC 60601-2-54 Edition 1.0 Withdrawn and 2009-06 Medical electrical replaced with equipment--Part 2-54: newer version Particular requirements including for the basic safety and technical essential performance of corrigendum. x-ray equipment for radiography and radioscopy [Including: Technical corrigendum 1 (2010), technical corrigendum 2 (2011)] 12-220 IEC 60825-1 (Second Withdrawn. See edition-2007) Safety of 12-273. laser products--Part 1: Equipment classification and requirements corrigendum 1 12-239 IEC 60825-1 (Second Withdrawn. See edition-2007) I-SH 01 12-273. Safety of laser products-- Part 1: Equipment classification and requirements, interpretation sheet 1 12-240 IEC 60825-1 (2007) Second Withdrawn. See edition, I-SH 02 Safety of 12-273. 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 2013 Standard for software replaced with in programmable components newer version. 13-15 CLSI AUTO13-A2 Laboratory New designation instruments and data number. 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) Reaffirmation. Medical 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 edition 2014-03-01 Health replaced with informatics--Personal newer version. health device communication--Part 10417: Device specialization: Glucose meter 14-181 14-432 ANSI/AAMI ST58:2013 Withdrawn and Chemical sterilization and replaced with high-level disinfection in newer version. health care facilities 14-228 ANSI/AAMI/ISO 11135-1:2007 Withdrawn. See Sterilization of 14-452. healthcare products-- Ethylene oxide--Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices 14-232 14-433 ASTM F2227-13 Standard Withdrawn and test method for non- replaced with destructive detection of newer version. leaks in non-sealed and empty packaging trays by CO[2] tracer gas method 14-233 14-434 ASTM F2228-13 Standard Withdrawn and test method for non- replaced with destructive detection of newer version. leaks in packaging which incorporates porous barrier material by CO[2] 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 Withdrawn and test method for thickness replaced with measurement of flexible newer version. packaging material 14-261 ANSI/AAMI/ISO 17665- Reaffirmation. 1:2006/(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 Reaffirmation. ST65:2008/(R)2013 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 Reaffirmation. ST24:1999/(R)2013 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities 14-291 ANSI/AAMI/ISO Reaffirmation. 14937:2009/(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 Withdrawn and 2014 Sterilization of replaced with healthcare products-- newer version. Ethylene oxide-- Requirements for the development, validation, and routine control of a sterilization process for medical devices 14-342 ASTM E2628-09 (E2009) Withdrawn. See Standard practice for 14-436. dosimetry in radiation 13-343 ASTM E2701-09 Standard Withdrawn. See guide for performance 14-437. characterization of dosimeters and dosimetry systems for use in radiation processing 14-348 ANSI/AAMI/ISO 13408- Reaffirmation. 2:2003/(R)2013 Aseptic processing of healthcare products--Part 2: Filtration 14-364 14-438 ANSI/AAMI/ISO 11137-2:2013 Withdrawn and Sterilization of health replaced with care products--Radiation-- newer version. Part 2: Establishing the sterilization dose 14-394 14-439 ANSI/AAMI ST79:2010, Withdrawn and A1:2010, A2:2011, A3:2012, replaced with and A4:2013 (consolidated newer version. text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities 14-414 14-440 USP 37NF32:2014 Withdrawn and Microbiological replaced with examination of nonsterile newer version. products: Microbial enumeration tests 14-415 14-441 USP 37NF32:2014 Sterility Withdrawn and tests replaced with newer version. 14-416 14-442 USP 37NF32:2014 Bacterial Withdrawn and endotoxins test replaced with newer version. 14-417 14-443 USP 37NF32:2014 Pyrogen Withdrawn and test (USP rabbit test) replaced with newer version. 14-418 14-444 USP 37NF32:2014 Withdrawn and Transfusion and infusion replaced with assemblies and similar newer version. medical devices 14-419 14-445 USP 37NF32:2014 Biological Withdrawn and indicator for steam replaced with sterilization--Self- newer version. contained 14-420 14-446 USP 37NF32:2014 Biological Withdrawn and indicator for dry-heat replaced with sterilization, paper newer version. carrier 14-421 14-447 USP 37NF32:2014 Biological Withdrawn and indicator for ethylene replaced with oxide sterilization, paper newer version. carrier 14-422 14-448 USP 37NF32:2014 Biological Withdrawn and indicator for steam replaced with sterilization, paper newer version. carrier 14-423 14-449 USP 37NF32:2014 Withdrawn and Microbiological replaced with examination of nonsterile newer version. products: Tests for specified microorganisms 14-425 ANSI/AAMI/ISO 13408- Reaffirmation. 6:2005/(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 Withdrawn and guide for characterization replaced with and testing of biomaterial newer version. scaffolds used in tissue- engineered medical products(TEMPs) 15-26 15-40 ASTM F2211-13 Standard Withdrawn and classification for tissue- replaced with engineered medical newer version. products (TEMPs) 15-33 15-41 ASTM F2602-13 Standard Withdrawn and test method for replaced with determining the molar mass newer version. of chitosan and chitosan salts by size exclusion chromatography with multi- angle light scattering detection (SEC-MALS)
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 Recognition No. Title of standard *1 Reference No. and date 3-127 Medical electrical ANSI/AAMI/IEC 60601-2- equipment--Part 2-47: 47:2012. Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems 3-128 Active implantable medical ANSI/AAMI/ISO 14117:2012. devices--Electromagnetic compatibility--EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesB. General I (Quality System/Risk Management (QS/RM)) 5-89 Medical electrical IEC 60601-1-6 Edition 3.1 equipment--Part 1-6: General 2013-10. requirements for basic safety and essential performance-- Collateral standard: Usability 5-92 Medical Electrical ANSI/AAMI/IEC 60601-1-8:2006 Equipment--Part 1-8: General & A1:2012. requirements for basic safety and essential performance-- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsC. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC )) 19-1 Medical electrical IEC 60601-1-2 Edition 3:2007- equipment--Part 1-2: General 03. requirements for basic safety and essential performance-- Collateral standard: electromagnetic compatibility--requirements and tests 19-2 Medical electrical ANSI/AAMI/IEC 60601-1- equipment--Part 1-2: General 2:2007/(R)2012. requirements for basic safety and essential performance-- Collateral standard: electromagnetic compatibility--requirements and tests 19-3 Medical electrical IEC 60601-1-10 Edition equipment--Part 1-10: General 1.0:2007-11. requirements for basic safety and essential performance-- Collateral standard: requirements for the development of physiologic closed-loop controllers 19-4 Medical electrical ANSI/AAMI ES60601- equipment--Part 1: General 1:2005/(R)2012 and requirements for basic safety A1:2012,C1:2009/(R)2012 and and essential performance A2:2010/(R)2012. (IEC 60601-1:2005, mod) 19-5 Medical electrical ANSI/AAMI ES60601- equipment--Part 1: General 1:2005/(R)2012 and requirements for basic safety C1:2009/(R)2012 and, and essential performance A2:2010/(R)2012 (Consolidated (IEC 60601-1:2005, mod) text). 19-6 Medical electrical IEC 60601-1-11 Edition equipment--Part 1-11: General 1.0:2010-04. 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)] 19-7 Medical electrical ANSI/AAMI HA60601-1-11:2011. 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 (IEC 60601-1- 11:2010 mod) 19-8 Medical electrical IEC 60601-1-2 Edition equipment--Part 1-2: General 4.0:2014-02. requirements for basic safety and essential performance-- Collateral standard: Electromagnetic disturbances--Requirements and tests 19-9 Medical electrical IEC 60601-1-10 Edition equipment--Part 1-10: General 1.1:2013-11. requirements for 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 Edition 2011. batteries 11-279 Standard practice for finite ASTM F2996-13. 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 12-275 Ultrasonics--Power IEC 61161 Edition 3.0:2013- measurement--Radiation force 01. balances and performance requirements 12-276 Ultrasonics--Output test-- IEC TS 62462 First edition Guide for the maintenance of 2007-05. ultrasound physiotherapy systems 12-277 Ultrasonics--Hydrophones-- IEC 62127-1 Edition 1.1:2013- Part 1: Measurement and 02. characterization of medical ultrasonic fields up to 40 megahertz (MHz) 12-278 Ultrasonics--Hydrophones-- IEC 62127-2 Edition 1.0:2007- Part 2: Calibration for 08. ultrasonic fields up to 40 MHz (including corrigendum 1:2008 and amendment 1:2013) 12-279 Ultrasonics--Hydrophones-- IEC 62127-3 Edition 1.1:2013- Part 3: Properties of 05. hydrophones for ultrasonic fields up to 40 MHz 12-280 Ultrasonics--Power IEC 62555 Edition 1.0:2013- measurement--High intensity 11. therapeutic ultrasound (HITU) transducers and systems 12-281 Medical electrical IEC 60601-2-62 Edition equipment--Part 2-62: 1.0:2013-07. Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment 12-282 Eyewear for protection ISO 12609-1 First edition against intense light sources 2013-07-15. used on humans and animals for cosmetic and medical applications--Part 1: Specification for products 12-283 Eyewear for protection ISO 12609-2 First edition against intense light sources 2013-07-15. used on humans and animals for cosmetic and medical applications--Part 2: Guidance for use F. Software/Informatics 13-67 Health informatics--Personal ISO/IEEE 11073-10418 First health device communication-- edition 2014-03-01. Part 10418: Device specialization--International normalized ratio (INR) monitor 13-68 Health informatics--Point-of- ISO 11073-90101 First edition care medical device 2008-01-15. communication--Part 90101: Analytical instruments-- Point-of-care test 13-69 Health Informatics--Personal ISO/IEEE 11073-10472 First health device communication-- edition 2012-11-01. Part 10472: Device specialization--Medication monitor 14-436 Practice for dosimetry in ISO/ASTM 52628 First edition radiation processing 2013-11-15. 14-437 Guide for performance ISO/ASTM 52701 First edition characterization of 2013-11-15. dosimeters and dosimetry systems for use in radiation processing 14-450 Biological indicators-- USP 37-NF32:2014 <55>. Resistance performance tests 14-451 Biological indicators for USP 37-NF32:2014 <1035>. sterilization *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
V. Recommendation of Standards for Recognition by
Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to [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.
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
Dated:
Assistant Commissioner for Policy.
[FR Doc. 2014-15989 Filed 7-8-14;
BILLING CODE 4164-01-P
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