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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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: 049” (Recognition List Number: 049), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

These modifications to the list of recognized standards are applicable June 7, 2018.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. 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: 049.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Start Printed Page 26466“Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

An electronic copy of Recognition List Number: 049 is available on the internet at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm.

See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 049 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 049” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, CDRHStandardsStaff@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (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 the Federal Register notice 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 FDA would implement its standard recognition program and provided the initial list of recognized standards. The guidance was updated in September 2007 and is available at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​ucm077274.htm.

Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://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 hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​default.htm.

II. Modifications to the List of Recognized Standards, Recognition List Number: 049

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 049” to identify the current modifications.

In table 1, FDA describes 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, FDA lists 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

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Anesthesiology
1-86ISO 8185 Third edition 2008-06-15 (Corrected version), Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systemsWithdrawn. See 1-138.
1-95ISO 5366-3 Second edition 2001-08-15 Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)]Withdrawn. See 1-117.
1-107ANSI/AAMI/ISO 5356-1:2004 Anaesthetic and respiratory equipment—Conical connectors—Part 1: Cones and socketsTransferred. See 1-62.
1-109ANSI/AAMI/ISO 5362:2006 Anaesthetic reservoir bagsTransferred. See 1-75.
1-1211-129ISO 5359 Fourth edition 2014-10-01 Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]Withdrawn and replaced with newer version including amendment.
1-1281-130ISO 18082 First edition 2014-06-15 Anaesthetic and respiratory equipment—Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]Withdrawn and replaced with newer version including amendment.
B. Biocompatibility
2-118ANSI/AAMI/ISO 10993-11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicityTransferred. See 2-176.
2-120ANSI/AAMI/ISO 10993-6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantationWithdrawn.
2-153ANSI/AAMI/ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicityTransferred. See 2-245.
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2-156ANSI/AAMI/ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management processTransferred. See 2-220.
2-163ANSI/AAMI/ISO 10993-9:2009/(R)2014 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation productsTransferred. See 2-168.
2-165ANSI/AAMI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products form ceramicsTransferred. See 2-170.
2-1712-249ISO 10993-16 Third edition 2017-05 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesWithdrawn and replaced with newer version.
2-172ANSI/AAMI/TIR 10993-19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materialsTransferred. See 2-167.
2-173ANSI/AAMI/ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitizationTransferred. See 2-174.
2-180ANSI/AAMI/ISO 10993-16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devicesWithdrawn.
2-181ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices for human subjects—Good clinical practice [Including: Technical Corrigendum 1 (2011)]Transferred. See 2-205.
2-190ANSI/AAMI/ISO 10993-13:2010/(R)2014 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devicesTransferred. See 2-169.
2-198ANSI/AAMI/ISO 10993-12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materialsTransferred. See 2-191.
2-2072-250ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of MaterialsWithdrawn and replaced with newer version.
2-221ANSI/AAMI/ISO 10993-2:2006 (R2014) Biological evaluation of medical devices—Part 2: Animal welfare requirementsTransferred. See 2-222.
2-226ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicityTransferred. See 2-228.
2-2292-251USP 40-NF35:2017 <87> Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
2-2302-252USP 40-NF35:2017 <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
2-2312-253USP 40-NF35:2017 <88> Biological Reactivity Tests, In VivoWithdrawn and replaced with newer version.
2-2322-254USP 40-NF35:2017 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version. Extent of Recognition.
2-234ANSI/AAMI/ISO 10993-4:2002/(R) 2013 & A1:2006/(R)2013 Biological evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)]Withdrawn.
2-236ANSI/AAMI/ISO 10993-17:2002(R) 2012 Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substancesTransferred. See 2-237.
2-239ANSI/AAMI/ISO TIR 10993-20:2006 Biological Evaluation of Medical Devices—Part 20: Principles and methods for immunotoxicology testing of medical devicesTransferred. See 2-240.
2-242ANSI/AAMI/ISO TIR 37137:2014 Cardiovascular biological evaluation of medical devices—Guidance for absorbable implantsTransferred. See 2-241.
C. Cardiovascular
3-80ANSI/AAMI/ISO 81060-1:2007/(R)2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement typeTransferred. See 3-96.
3-83ANSI/AAMI/ISO 14708-5:2010 Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devicesTransferred. See 3-92.
3-101ANSI/AAMI/IEC 60601-2-27:2011 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentTransferred. See 3-126.
3-106ANSI/AAMI/IEC 60601-2-25:2011/(R)2016 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographsTransferred. See 3-105.
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3-109ANSI/AAMI/ISO 27186:2010 Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirementsTransferred. See 3-89.
3-111ANSI/AAMI/ISO 25539-3:2011 Cardiovascular implants—Endovascular devices—Part 3: Vena cava filtersTransferred. See 3-103.
3-112ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators)Transferred. See 3-124.
3-117ANSI/AAMI/ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeTransferred. See 3-122.
3-120ANSI/AAMI/ISO 25539-2:2012 Cardiovascular implants—Endovascular devices—Part 2: Vascular stentsTransferred. See 3-116.
3-1243-150ISO 7199 Third edition 2016-11-15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)Withdrawn and replaced with newer version.
3-128ANSI/AAMI/ISO 14117:2012 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesTransferred. See 3-139.
3-1303-151ANSI/AAMI/IEC 80601-2-30:2009 & A1:2013/(R2016) Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometersReaffirmation. Extent of Recognition. Transferred. See 3-123.
3-131ANSI/AAMI/ISO 27185:2012 Cardiac rhythm management devices—Symbols to be used with cardiac rhythm management device labels, and information to be supplied—General requirementsTransferred. See 3-132.
3-140ANSI/AAMI/ISO 5840-3:2013 Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniquesTransferred. See 3-133.
3-141ANSI/AAMI/ISO 5841-3:2013 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakersTransferred. See 3-125.
3-146ANSI/AAMI/ISO 5840-1:2015 Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirementsTransferred. See 3-145.
3-148ANSI/AAMI/ISO 5840-2:2015 Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutesTransferred. See 3-147.
D. Dental/Ear, Nose, and Throat (ENT)
4-50ADA Specification No. 18: 1992 Alginate Impression MaterialsWithdrawn. See 4-240.
4-89ANSI/ADA Specification No. 53 Reaffirmed by ANSI: August 2013 Polymer-Based Crown and Bridge MaterialsReaffirmation.
4-91ANSI/ADA Standard No. 80/ISO 7491:2000 Reaffirmed by ANSI: May 2013 Dental Materials—Determination of Color StabilityTransferred. See 4-241.
4-119ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material SystemsWithdrawn. See 4-240.
4-193ANSI/ADA Standard No. 15-2008/ISO 22112:2005 Reaffirmed by ANSI: May 2013 Artificial Teeth for Dental ProsthesesTransferred. See 4-151.
4-230ANSI/ADA Standard No. 30/ISO 3107:2011 Approved by ANSI: February 2013 Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol CementsTransferred. See 4-198.
4-235ANSI/ADA Standard No. 100/ISO 27020:2010 Approved by ANSI: November 2012 Orthodontic Brackets and TubesTransferred. See 4-218.
4-237ANSI/ADA Standard No.120-2009/ISO 20127:2005 Reaffirmed by ANSI: September 8, 2014 Powered ToothbrushesTransferred. See 4-238.
E. General I (Quality Systems/Risk Management) (QS/RM)
5-65ANSI/AAMI/ISO 80369-1:2010 Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirementsTransferred. See 5-63.
5-70ANSI/AAMI/ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices—Application of risk management to medical devicesTransferred. See 5-40.
5-92ANSI/AAMI/IEC 60601-1-8:2006 and A1:2012 Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsTransferred. See 5-76.
5-96ANSI/AAMI/IEC 62366-1:2015 Medical devices—Part 1: Application of usability engineering to medical devicesTransferred. See 5-114.
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5-100ANSI/AAMI/ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methodsTransferred. See 5-97.
5-118ANSI/AAMI/ISO 15223-1:2016 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirementsTransferred. See 5-117.
5-119ANSI/AAMI/ISO 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applicationsTransferred. See 5-107.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19-2ANSI/AAMI/IEC 60601-1-2:2007 (R2012) Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and testsTransferred. See 19-1.
19-12ANSI/AAMI/IEC 60601-1-2:2014 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and testsTransferred. See 19-8.
G. General Hospital/General Plastic Surgery (GH/GPS)
6-1496-401ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical GlovesWithdrawn and replaced with newer version.
6-178ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical GlovesReaffirmation.
6-214ASTM D6355-07 (Reapproved 2017) Standard Test Method for Human Repeat Insult Patch Testing of Medical GloveReaffirmation.
6-2176-402ASTM F1670/F1670M-17 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodWithdrawn and replaced with newer version.
6-227ANSI/AAMI/IEC 60601-2-21:2009 Medical electrical equipment—Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmersTransferred. See 6-388.
6-229ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipmentTransferred. See 6-389.
6-2326-403ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurementWithdrawn and replaced with newer version.
6-230ANSI/AAMI/IEC 60601-2-19:2009 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubatorsTransferred. See 6-385.
6-235ANSI/AAMI/IEC 60601-2-50:2009 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipmentTransferred. See 6-387.
6-270ASTM F1840-10 (Reapproved 2016) Standard Terminology for Surgical Suture NeedlesReaffirmation.
6-3046-404ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use—Part 1: Syringes for manual useWithdrawn and replaced with newer version.
6-3076-405IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment—Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screeningWithdrawn and replaced with newer version.
6-3236-406ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)Withdrawn and replaced with newer version.
6-337ANSI/AAMI/IEC 60601-2-20:2009 Medical electrical equipment—Part 2-20: Particular requirements for the basic safety and essential performance of transport incubators [Including AMENDMENT 1 (2016)]Transferred. See 6-386.
H. In Vitro Diagnostics (IVD)
7-271CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility TestingExtent of recognition.
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I. Materials
8-113ASTM F1147-05 (Reapproved 2017) ε1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsReaffirmation.
8-337ASTM F621-12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical ImplantsReaffirmation.
8-356ASTM F67-13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)Reaffirmation.
8-4468-460ASTM F2848-17 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene YarnsWithdrawn and replaced with newer version. Extent of recognition.
J. Nanotechnology
No new entries at this time
K. Neurology
17-1ANSI/AAMI NS28:1988/(R)2015 Intracranial pressure monitoring devicesReaffirmation. Extent of recognition.
17-817-15ISO 14708-3 Second edition 2017-04 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulatorsWithdrawn and replaced with newer version.
17-10ANSI/AAMI/ISO 14708-3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulatorsWithdrawn.
17-1117-16IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment—Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulatorsWithdrawn and replaced with newer version.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9-64ANSI/AAMI/IEC 60601-2-2:2009 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessoriesWithdrawn. Duplicate recognition. See 6-229.
9-66ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofiltersTransferred. See 9-89.
9-81ANSI/AAMI/IEC 60601-2-16:2012 Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipmentTransferred. See 9-80
9-91ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]Transferred. See 9-92.
9-919-114IEC 60601-2-18: Edition 3.0 2009-08, medical electrical equipment—part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipmentWithdrawn and replaced with new recognition number.
9-939-115ISO 25841 Third edition 2017-08 Female condoms—Requirements and test methodsWithdrawn and replaced with newer version.
9-103ANSI/AAMI/ISO 26722:2014 Water treatment equipment for haemodialysis applications and related therapiesTransferred. See 9-101.
9-104ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapiesTransferred. See 9-97.
9-105ANSI/AAMI/ISO 13959:2014 Water for hemodialysis and related therapiesTransferred. See 9-98.
9-106ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis and related therapiesTransferred. See 9-100.
9-107ANSI/AAMI/ISO 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapiesTransferred. See 9-99.
M. Ophthalmic
10-4310-105ISO 11979-8 Third edition 2017-04 Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental requirementsWithdrawn and replaced with newer version.
10-4610-106ISO 18369-3 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 3: Measurement methodsWithdrawn and replaced with newer version.
10-5410-107ISO 18369-4 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 4: Physicochemical properties of contact lens materialsWithdrawn and replaced with newer version.
10-8010-108ISO 18369-2 Third edition 2017-08 Ophthalmic optics—Contact lenses—Part 2: TolerancesWithdrawn and replaced with newer version.
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10-8310-109ISO 18369-1 Second edition 2017-08 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labelling specificationsWithdrawn and replaced with newer version.
N. Orthopedic
11-259ASTM F2887—12 Standard Specification for Total Elbow ProsthesesWithdrawn. See 11-321.
O. Physical Medicine
16-20016-201ISO 7176-19 Second edition 2008-07-15 AMENDMENT 1 2015-11-15. Wheelchairs—Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]Withdrawn and replaced with a newer version including amendment.
P. Radiology
12-139NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3Withdrawn. Duplicate recognition. See 12-105.
12-20212-308IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment—Part 2-43: Particular requirements for the safety and essential performance of X-Ray Equipment for interventional proceduresWithdrawn and replaced with newer version.
12-20412-309IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosisWithdrawn and replaced with newer version.
12-25112-310IEC 60601-2-63 Edition 1.1 2017-07 CONSOLIDATED VERSION Medical electrical equipment—Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-Ray equipmentWithdrawn and replaced with newer version.
12-25212-311IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-Ray equipmentWithdrawn and replaced with newer version.
12-22712-312IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function responseWithdrawn and replaced with newer version.
12-27612-313IEC TS 62462 Edition 2.0 2017-07 Ultrasonics—Output test—Guidance for the maintenance of ultrasound physiotherapy systemsWithdrawn and replaced with newer version.
12-15512-314ISO 11554 Fourth edition 2017-07 Optics and photonics—Lasers and laser-related equipment—Test methods for laser beam power, energy and temporal characteristicsWithdrawn and replaced with newer version.
12-19212-315NEMA Standards Publication MS 8-2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging SystemsWithdrawn and replaced with newer version.
12-25812-316IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fieldsWithdrawn and replaced with newer version.
Q. Software/Informatics
13-39ANSI/AAMI/IEC 80001-1:2010 Application of risk management for IT Networks incorporating medical devices—Part 1: Roles, responsibilities and activitiesTransferred. See 13-38.
13-41ANSI/AAMI/IEC TIR80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices—Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examplesTransferred. See 13-40.
13-43ANSI/AAMI/IEC TIR80001-2-2:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controlsTransferred. See 13-42.
13-45ANSI/AAMI/IEC TIR80001-2-3:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-3: Guidance for wireless networksTransferred. See 13-44.
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13-64ANSI/AAMI/IEC TIR80001-2-4:2012 Technical Information Report Application of risk management for IT-networks incorporating medical devices—Part 2-4: General implementation guidance for healthcare delivery organizationsTransferred. See 13-63.
R. Sterility
14-221ANSI/AAMI/ISO TIR 11139:2006 Sterilization of health care products—VocabularyTransferred. See 14-325.
14-222ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipmentTransferred. See 14-354.
14-227ANSI/AAMI/ISO 11737-1:2006 (R)2011 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on productTransferred. See 14-407.
14-238ANSI/AAMI/ISO 11140-5:2007/(R)2012 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packsTransferred. See 14-332.
14-261ANSI/AAMI/ISO 17665-1:2006/(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 devicesTransferred. See 14-333.
14-274ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of resultsTransferred. See 14-334.
14-278ANSI/AAMI/ISO 10993-7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsTransferred. See 14-408.
14-285ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of resultsTransferred. See 14-336.
14-287ANSI/AAMI/ISO 11737-2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processTransferred. See 14-327.
14-291ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesTransferred. See 14-337.
14-295ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devicesReaffirmation.
14-298ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspectsWithdrawn. See 14-510.
14-33014-510ISO 11137-3 Second edition 2017-06 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine controlWithdrawn and replaced with newer version.
14-339ANSI/AAMI/ISO 20857:2010/(R)2015 Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devicesTransferred. See 14-340.
14-348ANSI/AAMI/ISO 13408-2:2003/(R)2013 Aseptic processing of health care products—Part 2: FiltrationTransferred. See 14-138.
14-349ANSI/AAMI/ISO 13408-3:2006/(R)2015 Aseptic processing of health care products—Part 3: LyophilizationTransferred. See 14-239.
14-350ANSI/AAMI/ISO 13408-4:2005/(R)2014 Aseptic processing of health care products—Part 4: Clean-in-place technologiesTransferred. See 14-191.
14-351ANSI/AAMI/ISO 13408-5:2006/(R)2015 Aseptic processing of health care products—Part 5: Sterilization in placeTransferred. See 14-240.
14-358ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devicesTransferred. See 14-361.
14-376ANSI/AAMI/ISO TIR 17665-2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1Transferred. See 14-277.
14-387ANSI/AAMI/ISO 13408-7:2012 Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination productsTransferred. See 14-388.
14-425ANSI/AAMI/ISO 13408-6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products—Part 6: Isolator systems [Including AMENDMENT1 (2013)]Transferred. See 14-424.
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14-426ANSI/AAMI/ISO 13408-1:2008 (R2011) Aseptic processing of health care products—Part 1: General requirements [Including AMENDMENT1 (2013)]Transferred. See 14-427.
14-438ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseTransferred. See 14-409.
14-43914-511ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilitiesWithdrawn and replaced with newer version.
14-457ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging [Including AMENDMENT 1 (2013)]Transferred. See 14-454.
14-458ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including AMENDMENT 1 (2013)]Transferred. See 14-455.
14-459ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products—Chemical indicators—Part 1: General requirementsTransferred. See 14-460.
14-461ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]Transferred. See 14-428.
14-479ANSI/AAMI/ISO 11135:2014 Sterilization of health care products—Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devicesTransferred. See 14-452.
S. Tissue Engineering
15-17ASTM F2311-08 Standard Guide for Classification of Therapeutic Skin SubstitutesWithdrawn.
15-23ASTM F2739-08 Standard Guide for Quantitating Cell Viability within Biomaterial ScaffoldsWithdrawn. See 15-50.
15-3715-51ASTM F2347-15 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product ApplicationsWithdrawn and replaced with newer version.
15-4215-52ASTM F2064-17 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product ApplicationsWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 049.

Table 2—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and Date
A. Anesthesiology
1-131Medical suction equipment—Part 1: Electrically powered suction equipmentISO 10079-1 Third Edition 2015-11-01.
1-132Medical suction equipment—Part 2: Manually powered suction equipmentISO 10079-2 Third Edition 2014-05-01.
1-133Medical suction equipment—Part 3: Suction equipment powered from a vacuum or positive pressure gas sourceISO 10079-3 Third Edition 2014-05-01.
1-134Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1: Evaluation and testing within a risk management processISO 18562-1 First edition 2017-03.
1-135Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 2: Tests for emissions of particulate matterISO 18562-2 First edition 2017-03.
1-136Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 3: Tests for emissions of volatile organic compoundsISO 18562-3 First edition 2017-03.
1-137Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 4: Tests for leachables in condensateISO 18562-4 First edition 2017-03.
1-138Medical electrical equipment—Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipmentISO 80601-2-74 First edition 2017-05.
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B. Biocompatibility
No new entries at this time
C. Cardiovascular
No new entries at this time
D. Dental/Ear, Nose, and Throat (ENT)
4-240Dentistry—Hydrocolloid impression materialsISO 21563 First edition 2013-08-15.
4-241Dental materials—Determination of colour stabilityISO 7491 Second edition 2000-09-01.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time
G. General Hospital/General Plastic Surgery (GH/GPS)
6-407Standard Specification for Adult Portable Bed Rails and Related ProductsASTM F3186-17.
H. In Vitro Diagnostics (IVD)
7-274Verification and Validation of Multiplex Nucleic Acid Assays; Approved GuidelineCLSI MM17-A Vol. 28 No. 9 (Replaces MM17-P Vol. 27 No. 21).
I. Materials
8-461Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical DevicesASTM F3208-17.
8-462Standard Test Method for Determining the Flexural Stiffness of Medical TextilesASTM F3260-17.
8-463Standard Guide for Additive Manufacturing—General Principles—Requirements for Purchased AM PartsISO/ASTM 52901 First edition 2017-08.
8-464Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical deviceISO 10974 Second edition 2018.
J. Nanotechnology
18-9Nanotechnologies—Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]ISO/TR 13014 First edition 2012-05-15.
18-10Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus amebocyte lysate (LAL) testISO 29701 First edition 2010-09-15.
K. Neurology
No new entries at this time
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9-115Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies based on self-reportsISO 29943-1 First edition 2017-07.
9-116Condoms—Guidance on clinical studies—Part 2: Female condoms, clinical function studies based on self-reportsISO 29943-2 First edition 2017-07.
M. Ophthalmic
10-110Ophthalmic implants—Ophthalmic viscosurgical devices [Including AMENDMENT 1 (2017)]ISO 15798 Third edition 2013-09-15 AMENDMENT 1 2017-05.
N. Orthopedic
No new entries at this time
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O. Physical Medicine
16-202RESNA Standard for Wheelchairs Volume 4: Wheelchairs and TransportationRESNA WC-4:2017.
P. Radiology
No new entries at this time
Q. Software/Informatics
13-104Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness SystemsANSI/UL 2900-2-1, First Edition September 1, 2017.
R. Sterility
No new entries at this time
S. Tissue Engineering
15-53Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular TherapiesASTM F3206 -17.
15-54Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion ModelASTM F3207-17.
1 All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. FDA will be incorporating 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. FDA will be announcing 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 049, FDA will no longer include in the database the CDRH Office and Division associated with recognized standards, Devices Affected, and Processes Affected. Beginning with recognition list 049 FDA will automatically incorporate, upon publication, a U.S. parallel adoption of an existing recognized international standard.

V. Recommendation of Standards for Recognition by FDA

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 CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the following information available at https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123739.htm.

Start Signature

Dated: May 31, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-12222 Filed 6-6-18; 8:45 am]

BILLING CODE 4164-01-P