| Page Range | 39591-39598 | |
| FR Document | 2017-17603 |
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)] [Notices] [Pages 39591-39598] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17603] [[Page 39591]] ----------------------------------------------------------------------- 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: 047 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: 047'' (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective August 21, 2017. 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: 047.'' 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: 047. 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.thefederalregister.org/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 ``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: 047 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: 047 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: 047'' 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, 301-796-6287. Send one self- addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144. 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, [email protected]. 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 (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 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 [[Page 39592]] standards. The guidance was updated in September 2007 and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized standards 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: 047 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: 047'' 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 ---------------------------------------------------------------------------------------------------------------- Replacement Old recognition No. recognition Title of standard \1\ Change No. ---------------------------------------------------------------------------------------------------------------- A. Anesthesiology ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ............................ ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-114..................... 2-246 ASTM F1877--16 Standard Practice for Withdrawn and replaced with Characterization of Particles. newer version. 2-155..................... .............. ASTM F2147--01 (Reapproved 2016) Reaffirmation. Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. 2-177..................... 2-247 ISO 10993-6 Third edition 2016-12-01 Withdrawn and replaced with Biological evaluation of medical newer version. devices--Part 6: Tests for local effects after implantation. 2-235..................... 2-248 ISO 10993-4 Third edition 2017-04 Withdrawn and replaced with Biological evaluation of medical newer version. Extent of devices--Part 4: Selection of tests recognition. for interactions with blood. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-121..................... 3-149 ISO 25539-1 Second edition 2017-02 Withdrawn and replaced with Cardiovascular implants--Endovascular newer version. devices--Part 1: Endovascular prostheses. 3-142..................... .............. ISO/TS 17137 First edition 2014-05-15 Extent of recognition. Cardiovascular implants and extracorporeal systems-- Cardiovascular absorbable implants. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-96...................... 4-230 ANSI/ADA Standard No. 30-2013/ISO 3107 Withdrawn and replaced with Dental Zinc Oxide/Eugenol & Zinc newer version. Extent of Oxide/Non-Eugenol Cements. recognition. 4-193..................... .............. ANSI/ADA Standard No. 15-2008 (R2013)/ Extent of recognition. ISO 22112 Artificial Teeth for Dental Prostheses. 4-215..................... .............. ANSI/ADA Standard No. 96-2012 Dental Extent of recognition. Water-based Cements. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management) (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-90...................... 5-117 ISO 15223-1 Third edition 2016-11-01 Withdrawn and replaced with Medical devices--symbols to be used newer version. with medical device labels, labelling, and information to be supplied--part 1: General requirements. 5-91...................... 5-118 ANSI/AAMI/ISO 15223-1: 2016 Medical Withdrawn and replaced with devices--symbols to be used with newer version. medical device labels, labelling, and information to be supplied--part 1: General requirements. 5-107..................... .............. IEC 80369-5: Edition 1.0 2016-03 Small- Technical corrigendum added. bore connectors for liquids and gases in healthcare applications--Part 5: Connectors for limb cuff inflation applications [Including CORRIGENDUM 1 (2017)]. ---------------------------------------------------------------------------------------------------------------- [[Page 39593]] F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ---------------------------------------------------------------------------------------------------------------- No new entries at this time........... ---------------------------------------------------------------------------------------------------------------- G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-70...................... .............. ASTM E825-98 (Reapproved 2016) Reaffirmation. Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature. 6-124..................... .............. ASTM E1104-98 (Reapproved 2016) Reaffirmation Standard Specification for Clinical Thermometer Probe Covers and Sheaths. 6-125..................... .............. ASTM E1965-98 (Reapproved 2016) Reaffirmation. Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. 6-297..................... 6-384 ISO 1135-4 Sixth edition 2015-12-01 Withdrawn and replaced with Transfusion equipment for medical use- newer version. Part 4: Transfusion sets for single use, gravity feed. 6-319..................... 6-385 IEC 60601-2-19 Edition 2.1 2016-04 Withdrawn and replaced with CONSOLIDATED VERSION Medical newer version including electrical equipment--Part 2-19: amendment. Particular requirements for the basic safety and essential performance of infant incubators [Including AMENDMENT 1 (2016)]. 6-320..................... 6-386 IEC 60601-2-20 Edition 2.1 2016-04 Withdrawn and replaced with CONSOLIDATED VERSION Medical newer version including electrical equipment--Part 2-20: amendment. Particular requirements for the basic safety and essential performance of infant transport incubators [Including AMENDMENT 1 (2016)]. 6-324..................... 6-387 IEC 60601-2-50 Edition 2.1 2016-04 Withdrawn and replaced with CONSOLIDATED VERSION Medical newer version including electrical equipment--Part 2-50: amendment. Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including AMENDMENT 1 (2016)]. 6-325..................... 6-388 IEC 60601-2-21 Edition 2.1 2016-04 Withdrawn and replaced with CONSOLIDATED VERSION Medical newer version including electrical equipment--Part 2-21: amendment. Particular requirements for the basic safety and essential performance of infant radiant warmers [Including AMENDMENT 1 (2016)]. 6-336..................... 6-389 IEC 60601-2-2 Edition 6.0 2017-03 Withdrawn and replaced with Medical electrical equipment--Part 2- newer version. 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. 6-342..................... 6-390 IEC 80601-2-35 Edition 2.1 2016-04 Withdrawn and replaced with CONSOLIDATED VERSION Medical newer version including electrical equipment--Part 2-35: amendment. Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including AMENDMENT 1 (2016)]. 6-367..................... 6-391 USP 40-NF35:2017, Sodium Chloride Withdrawn and replaced with Irrigation. newer version. 6-368..................... 6-392 USP 40-NF35:2017, Sodium Chloride Withdrawn and replaced with Injection. newer version. 6-369..................... 6-393 USP 40-NF35:2017, Nonabsorbable Withdrawn and replaced with Surgical Suture. newer version. 6-370..................... 6-394 USP 40-NF35:2017, <881> Tensile Withdrawn and replaced with Strength. newer version. 6-371..................... 6-395 USP 40-NF35:2017, <861> Sutures-- Withdrawn and replaced with Diameter. newer version. 6-372..................... 6-396 USP 40-NF35:2017, <871> Sutures-- Withdrawn and replaced with Needle Attachment. newer version. 6-373..................... 6-397 USP 40-NF35:2017, Sterile Water for Withdrawn and replaced with Irrigation. newer version. 6-374..................... 6-398 USP 40-NF35:2017, Heparin Lock Flush Withdrawn and replaced with Solution. newer version. 6-375..................... 6-399 USP 40-NF35:2017, Absorbable Surgical Withdrawn and replaced with Suture. newer version. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-206..................... 7-270 I/LA-20 3rd Edition Analytical Withdrawn and replaced with Performance Characteristics, Quality newer version. Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities. [[Page 39594]] 7-263..................... 7-271 CLSI M100 27th Edition Performance Withdrawn and replaced with Standards for Antimicrobial newer version. Susceptibility Testing. ---------------------------------------------------------------------------------------------------------------- I. Materials ---------------------------------------------------------------------------------------------------------------- 8-58...................... 8-447 ISO 5832-3 Fourth edition 2016-10-15 Withdrawn and replaced with Implants for surgery--Metallic newer version. Extent of materials--Part 3: Wrought titanium 6- recognition. aluminium 4-vanadium alloy. 8-125..................... 8-448 ASTM F2004-16 Standard Test Method for Withdrawn and replaced with Transformation Temperature of Nickel- newer version. Titanium Alloys by Thermal Analysis. 8-165..................... 8-449 ASTM F1058-16 Standard Specification Withdrawn and replaced with for Wrought 40Cobalt-20 Chromium- newer version. 16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008). 8-185..................... 8-450 ASTM F451-16 Standard Specification Withdrawn and replaced with for Acrylic Bone Cement. newer version. 8-187..................... .............. ISO 13779-1:2008 Second edition 2008- Withdrawn. 10-01 Implants for surgery-- Hydroxyapatite--Part 1: Ceramic hydroxyapatite. 8-195..................... .............. ASTM F2024-10 (Reapproved 2016) Reaffirmation. Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings. 8-201..................... 8-451 ASTM F2214-16 Standard Test Method for Withdrawn and replaced with In Situ Determination of Network newer version. Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE). 8-202..................... .............. ASTM F2183-02 (Reapproved 2008) Withdrawn. Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017). 8-205..................... 8-452 ASTM F1635-16 Standard Test Method for Withdrawn and replaced with in vitro Degradation Testing of newer version. Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants. 8-216..................... 8-453 ASTM F1295-16 Standard Specification Withdrawn and replaced with for Wrought Titanium-6 Aluminum- newer version. 7Niobium Alloy for Surgical Implant Applications (UNS R56700). 8-226..................... .............. ASTM F603-12 (Reapproved 2016) Reaffirmation. Standard Specification for High- Purity Dense Aluminum Oxide for Medical Application. 8-333..................... .............. ASTM F2393-12 (Reapproved 2016) Reaffirmation. Standard Specification for High- Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications. 8-396..................... 8-454 ASTM F2129-17 Standard Test Method for Withdrawn and replaced with Conducting Cyclic Potentiodynamic newer version. Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. 8-428..................... .............. ASTM F1581-08 (Reapproved 2016) Reaffirmation. Standard Specification for Composition of Anorganic Bone for Surgical Implants. 8-410..................... 8-455 ASTM F2902-16 Standard Guide for Withdrawn and replaced with Assessment of Absorbable Polymeric newer version. Implants. ---------------------------------------------------------------------------------------------------------------- J. Nanotechnology ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ............................ ---------------------------------------------------------------------------------------------------------------- K. Neurology ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ............................ ---------------------------------------------------------------------------------------------------------------- L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ............................ ---------------------------------------------------------------------------------------------------------------- M. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-69..................... 10-103 ANSI Z80.18-2016 American National Withdrawn and replaced with Standard for Ophthalmics--Contact newer version. Lens Care Products--Vocabulary, Performance Specifications, and Test Methodology. 10-92..................... 10-104 ANSI Z80.20-2016 American National Withdrawn and replaced with Standard for Ophthalmics--Contact newer version. Lenses--Standard Terminology, Tolerances, Measurements and Physicochemical Properties. ---------------------------------------------------------------------------------------------------------------- N. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-175.................... .............. ASTM F1582-98 (Reapproved 2016) Reaffirmation. Standard Terminology Relating to Spinal Implants. [[Page 39595]] 11-242.................... .............. ASTM F1839-08 (Reapproved 2016) Reaffirmation. Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. 11-269.................... .............. ASTM F2423-11 (Reapproved 2016) Reaffirmation. Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses. 11-280.................... .............. ASTM F2624-12 (Reapproved 2016) Reaffirmation. Standard Test Method for Static, Dynamic, and Wear Assessment of Extra- Discal Single Level Spinal Constructs. 11-309.................... .............. ASTM F116-12 (Reapproved 2016) Reaffirmation. Standard Specification for Medical Screwdriver Bits. ---------------------------------------------------------------------------------------------------------------- O. Physical Medicine ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ............................ ---------------------------------------------------------------------------------------------------------------- P. Radiology ---------------------------------------------------------------------------------------------------------------- 12-234.................... 12-306 NEMA MS 12-2016 Quantification and Withdrawn and replaced with Mapping of Geometric Distortion for newer version. Special Applications. ---------------------------------------------------------------------------------------------------------------- Q. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-66..................... 13-88 ISO/IEEE 11073-10417 Third edition Withdrawn and replaced with 2017-04 Health informatics--Personal newer version. health device communication--Part 10417: Device specialization--Glucose meter. 13-67..................... .............. ISO/IEEE 11073-10418 First edition Technical Corrigendum added. 2014-03-01 Health informatics-- Personal health device communication-- Part 10418: Device specialization: International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]. ---------------------------------------------------------------------------------------------------------------- R. Sterility ---------------------------------------------------------------------------------------------------------------- 14-288.................... 14-501 ASTM F1886/F1886M-16 Standard Test Withdrawn and replaced with Method for Determining Integrity of newer version. Seals for Flexible Packaging by Visual Inspection. 14-338.................... 14-502 ISO 11138-1 Third edition 2017-03 Withdrawn and replaced with Sterilization of health care newer version. products--Biological indicators--Part 1: General requirements. 14-358.................... .............. ANSI/AAMI/ISO 14160:2011/(R)2016 Reaffirmation. Extent of Sterilization of health care recognition. 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 devices. 14-361.................... .............. ISO 14160 Second edition 2011-07-01 Extent of recognition. 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 devices. 14-485.................... 14-503 USP 40-NF35:2017, <61> Microbiological Withdrawn and replaced with Examination of Nonsterile Products: newer version. Microbial Enumeration Tests. 14-486.................... 14-504 USP 40-NF35:2017, <71> Sterility Tests Withdrawn and replaced with newer version. 14-487.................... 14-505 USP 40-NF35:2017, <85> Bacterial Withdrawn and replaced with Endotoxins Test. newer version. 14-488.................... 14-506 USP 40-NF35:2017, <161> Medical Withdrawn and replaced with Devices-Bacterial Endotoxin and newer version. Pyrogen Tests. 14-493.................... 14-507 USP 40-NF35:2017, <62> Microbiological Withdrawn and replaced with Examination of Nonsterile Products: newer version. Tests for Specified Microorganisms. 14-494.................... 14-508 USP 40-NF35:2017, <55> Biological Withdrawn and replaced with Indicators--Resistance Performance newer version. Tests. 14-495.................... 14-509 USP 40-NF35:2017, <1229.5> Biological Withdrawn and replaced with Indicators for Sterilization. newer version. ---------------------------------------------------------------------------------------------------------------- [[Page 39596]] S. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-20..................... 15-49 ASTM F2027-16 Standard Guide for Withdrawn and replaced with Characterization and Testing of Raw newer version. or Starting Materials for Tissue- Engineered Medical Products. ---------------------------------------------------------------------------------------------------------------- \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: 047. Table 2--New Entries to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Recognition No. Title of standard \1\ Reference No. and date ---------------------------------------------------------------------------------------------------------------- A. Anesthesiology ---------------------------------------------------------------------------------------------------------------- 1-121................................. Anaesthetic and respiratory equipment-- ISO 5359 Fourth edition 2014- Low-pressure hose assemblies for use 10-01. with medical gases. 1-122................................. Anaesthetic and respiratory equipment-- ISO 5364 Fifth edition 2016-09- Oropharyngeal airways. 01. 1-123................................. Anaesthetic and respiratory equipment-- ISO 7376 Second edition 2009- Laryngoscopes for tracheal intubation. 08-15. 1-124................................. Inhalational anaesthesia systems--Part ISO 8835-7 First edition 2011- 7: Anaesthetic systems for use in areas 11-01. with limited logistical supplies of electricity and anaesthetic gases. 1-125................................. Suction catheters for use in the ISO 8836 Fourth edition 2014- respiratory tract. 10-15. 1-126................................. Anaesthetic and respiratory equipment-- ISO 11712 First edition 2009- Supralaryngeal airways and connectors. 05-15. 1-127................................. Tracheobronchial tubes--Sizing and ISO 16628 First edition 2008- marking. 11-15. 1-128................................. Anaesthetic and respiratory equipment-- ISO 18082 First edition 2014- Dimensions of noninterchangeable screw- 06-15. threaded (NIST) low-pressure connectors for medical gases. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-231................................. Dentistry--Testing of adhesion to tooth ISO/TS 11405 Third edition structure. 2015-02-01. 4-232................................. Dentistry--Base polymers--Part 1: ISO 20795-1 Second edition Denture base polymers. 2013-03-01. 4-233................................. Dentistry--Base polymers--Part 2: ISO 20795-2 Second edition Orthodontic base polymers. 2013-03-01. 4-234................................. Dental Base Polymers.................... ANSI/ADA Standard No.139-2012. 4-235................................. Orthodontic Brackets and Tubes.......... ANSI/ADA Standard No.100-2012/ ISO 27020. 4-236................................. Manual Toothbrushes..................... ANSI/ADA Standard No.119-2015. 4-237................................. Powered Toothbrushes.................... ANSI/ADA Standard No.120-2009 (R2014)/ISO 20127. 4-238................................. Dentistry--Powered toothbrushes--General ISO 20127 First edition 2005- requirements and test methods. 03-15. 4-239................................. Cochlear Implant Systems: Requirements ANSI/AAMI CI 86:2017. for Safety, Functional Verification, Labeling and Reliability Reporting. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management) (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-119................................. Small-bore connectors for liquids and ANSI/AAMI/ISO 80369-5: 2016. gases in healthcare applications--Part 5: Connectors for limb cuff inflation applications. ---------------------------------------------------------------------------------------------------------------- F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ---------------------------------------------------------------------------------------------------------------- 19-22................................. Technical Information Report Risk AAMI TIR69: 2017. management of radio-frequency wireless coexistence for medical devices and systems. 19-23................................. Primary batteries--Part 4: Safety of IEC 60086-4 Edition 4.0 2014- lithium batteries. 09. 19-24................................. Primary batteries--Part 5: Safety of IEC 60086-5 Edition 4.0 2016- batteries with aqueous electrolyte. 07. 19-25................................. Safety requirements for secondary IEC 62485-1 Edition 1.0 2015- batteries and battery installations-- 04. Part 1: General safety information. 19-26................................. Safety requirements for secondary IEC 62485-2 Edition 1.0 2010- batteries and battery installations-- 06. Part 2: Stationary batteries. 19-27................................. Safety requirements for secondary IEC 62485-3 Edition 2.0 2014- batteries and battery installations-- 07. Part 3: Traction batteries. 19-28................................. Safety requirements for secondary IEC 62485-4 Edition 1.0 2015- batteries and battery installations-- 01. Part 4: Valve-regulated lead-acid batteries for use in portable appliances. 19-29................................. American National Standard for IEEE/ANSI C63.27-2017. Evaluation of Wireless Coexistence. ---------------------------------------------------------------------------------------------------------------- [[Page 39597]] G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-400................................. Standard Test Method for Coring Testing ASTM F3212-16. of Huber Needles. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-272................................. Mass Spectrometry for Androgen and CLSI C57 First edition. Estrogen Measurements in Serum. 7-273................................. Methods for the Identification of CLSI M58. Cultured Microorganisms Using Matrix- Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry. ---------------------------------------------------------------------------------------------------------------- I. Materials ---------------------------------------------------------------------------------------------------------------- 8-456................................. Implants for surgery--Plasma-sprayed ISO 13179-1 First edition 2014- unalloyed titanium coatings on metallic 06-01. surgical implants--Part 1: General requirements. 8-457................................. Implants for surgery--Calcium ISO 13175-3 First edition 2012- phosphates--Part 3: Hydroxyapatite and 10-01. beta-tricalcium phosphate bone substitutes. 8-458................................. Standard Reference Test Method for ASTM G5-14. Making Potentiodynamic Anodic Polarization Measurements. 8-459................................. Pyrometry............................... SAE/AMS2750 Rev. E 2012-07. ---------------------------------------------------------------------------------------------------------------- J. Nanotechnology ---------------------------------------------------------------------------------------------------------------- 18-5.................................. Standard Guide for Size Measurement of ASTM E2859-11. Nanoparticles Using Atomic Force Microscopy. 18-6.................................. Standard Guide for Measurement of ASTM E2865-12. Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials. 18-7.................................. Standard Guide for Measurement of ASTM E2834-12. Particle Size Distribution of Nanomaterials in Suspension by Nanoparticle Tracking Analysis (NTA). 18-8.................................. Standard Practice for Calculation of ASTM E2578-07 (Reapproved Mean Sizes/Diameters and Standard 2012). Deviations of Particle Size Distributions. ---------------------------------------------------------------------------------------------------------------- K. Neurology ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- M. Ophthalmic ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- N. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-321................................ Standard Specification for Total Elbow ASTM F2887-17. Prostheses. ---------------------------------------------------------------------------------------------------------------- O. Physical Medicine ---------------------------------------------------------------------------------------------------------------- 16-200................................ Wheelchairs--Part 19: Wheeled mobility ISO 7176-19 Second edition devices for use as seats in motor 2008-07-15. vehicles. ---------------------------------------------------------------------------------------------------------------- P. Radiology ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- Q. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-89................................. Health informatics--Personal health ISO/IEEE 11073-10406 First device communication--Part 10406: edition 2012-12-01. Device specialization--Basic electrocardiograph (ECG) (1- to 3-lead ECG). 13-90................................. Health Informatics--Personal Health IEEE Std 11073-10417-2015. Device Communication, Part 10417: Device Specialization--Glucose Meter. 13-91................................. Health informatics--Personal health ISO/IEEE 11073-10419 First device communication--Part 10419: edition 2016-06-15. Device specialization--Insulin pump. 13-92................................. Health informatics--Personal health ISO/IEEE 11073-10421 First device communication--Part 10421: edition 2012-11-01. Device specialization--Peak expiratory flow monitor (peak flow). 13-93................................. Health informatics--Personal health IEEE Std 11073-10422-2016. device communication, Part 10422: Device Specialization--Urine Analyzer. 13-94................................. Health informatics--Personal health ISO/IEEE 11073-10424 First device communication--Part 10424: edition 2016-06-15. Device specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE). 13-95................................. Health informatics--Personal health ISO/IEEE 11073-10425 First device communication--Part 10425: edition 2016-06-15. Device specialization--Continuous glucose monitor (CGM). 13-96................................. Standard for Software Cybersecurity UL 2900-1 Ed.1 2017. Network-Connectable Products, Part 1: General Requirements. 13-97................................. Health software--Part 1: General IEC 82304-1 Edition 1.0 2016- requirements for product safety. 10. ---------------------------------------------------------------------------------------------------------------- R. Sterility ---------------------------------------------------------------------------------------------------------------- No new entries at this time. ---------------------------------------------------------------------------------------------------------------- [[Page 39598]] S. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-50................................. Standard Guide for Quantifying Cell ASTM F2739-16. Viability within Biomaterial Scaffolds. ---------------------------------------------------------------------------------------------------------------- \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 in the Federal Register, as needed, once a year, or more often if necessary. 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 [email protected]. To be 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 electronic or mailing address of the requestor, (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. Dated: August 16, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17603 Filed 8-18-17; 8:45 am] BILLING CODE 4164-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective August 21, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 39591 |