| Page Range | 19196-19205 | |
| FR Document | 2016-07467 |
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)] [Notices] [Pages 19196-19205] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07467] ----------------------------------------------------------------------- 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: 041 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: 041'' (Recognition List Number: 041), 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 April 4, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 19197]] 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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: 041.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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: 041. 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 041 is available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 041 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: 041'' to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847- 8149. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (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 a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standards recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 041 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. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term ``Recognition List Number: 041'' to identify these 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 [[Page 19198]] 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. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-92............................. 1-106 ISO 17510 First Edition 2015-08- Withdrawn and replaced with 01 Medical Devices--Sleep newer version. Apnoea Breathing Therapy--Masks and Application Accessories. 1-93............................. .............. ISO 5361 Second Edition 2012-10- Extent of recognition. 01 Anaesthetic and Respiratory Equipment--Tracheal Tubes and Connectors. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-180............................ .............. ANSI/AAMI/ISO 10993-16:2010/(R) Reaffirmation. 2014 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-119............................ .............. ISO 5841-3 Third Edition 2013-04- Withdrawn--Duplicate 15 Implants for surgery-- recognition--See 3-125. Cardiac pacemakers--Part 3: Low- profile connectors [is-i] for implantable pacemakers. 3-138............................ .............. ASTM F2942-13 Standard Guide For Extent of recognition. the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-121............................ 4-221 ISO 7494-2 Second Edition 2015- Withdrawn and replaced with 04-01 Dentistry--Dental units-- newer version. Part 2: Air, water, suction and wastewater system. 4-132............................ 4-222 ISO 6874 Third Edition 2015-09- Withdrawn and replaced with 01 Dentistry--Polymer-based pit newer version. and fissure sealants. 4-178............................ 4-223 ISO 6872 Fourth Edition 2015-06- Withdrawn and replaced with 01 Dentistry--Ceramic materials. newer version. 4-190............................ .............. ANSI/ASA S3.35-2010 (R2015) Reaffirmation. Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions. 4-194............................ .............. ANSI/ADA Specification No. 78: Extent of recognition. 2006, Dental Obturating Cones (Modified adoption of ISO 6877- 1:1995, Dental Obturating Points). 4-202............................ .............. ANSI/ADA Specification No. 58 Extent of recognition. Root Canal Files, Type H (Hedstrom). 4-209............................ 4-224 ISO 24234 Second Edition 2015-05- Withdrawn and replaced with 01 Dentistry--Dental amalgam. newer version. 4-210............................ 4-225 ISO 4823 Fourth Edition 2015-08- Withdrawn and replaced with 01 Dentistry--Elastomeric newer version. impression materials. 4-213............................ .............. ISO 7494-1 Second Edition 2011- Extent of recognition. 08-15 Dentistry--Dental units-- Part 1: General requirements and test methods. 4-214............................ .............. ISO 10139-1 Second Edition 2005- Extent of recognition. 02-15 Dentistry--Soft lining materials for removable dentures--Part 1: Materials for short-term use [Including: Technical Corrigendum 1 (2006)]. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-43............................. 5-98 ANSI/ESD S20.20-2014 Protection Withdrawn and replaced with of Electrical and Electronic newer version. Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices). 5-80............................. 5-99 ASTM D4332-14 Standard Practice Withdrawn and replaced with for Conditioning Containers, newer version. Packages, or Packaging Components for Testing. ---------------------------------------------------------------------------------------------------------------- F. General II (Electrical Safety/Electromagnetic Compatibility)(ES/EMC) ---------------------------------------------------------------------------------------------------------------- 19-7............................. 19-16 ANSI/AAMI HA60601-1-11:2015 (IEC Withdrawn and replaced with 60601-1-11:2015, MOD) MEDICAL newer version. ELECTRICAL 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. 19-7............................. .............. AAMI/ANSI HA60601-1-11:2011, Transition period. Medical electrical equipment-- Part 1-11: General requirements for basic safety and essential performance--Collateral standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010 MOD). ---------------------------------------------------------------------------------------------------------------- [[Page 19199]] G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-169............................ 6-355 ASTM D3772--15 Standard Withdrawn and replaced with Specification for Industrial newer version. Rubber Finger Cots. 6-243............................ 6-356 ASTM D5712--15 Standard Test Withdrawn and replaced with Method for Analysis of Aqueous newer version. Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-167............................ 7-259 CLSI GP23-A Nongynecologic Withdrawn and replaced with Cytologic Specimens: Collection newer version. And Cytopreparatory Techniques; Approved Guideline. 7-132............................ 7-260 CLSI MM03-A2 Molecular Withdrawn and replaced with Diagnostic Methods for newer version. Infectious Diseases; Approved Guideline. 7-229............................ .............. CLSI M02-A11 Performance Withdrawn. See 7-258. Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard--Eleventh Edition. ---------------------------------------------------------------------------------------------------------------- I. Materials ---------------------------------------------------------------------------------------------------------------- 8-103............................ .............. ASTM F1807-97 (Reapproved 2014) Reaffirmation. Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials. 8-107............................ .............. ASTM F746-04 (Reapproved 2014) Reaffirmation. Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. 8-114............................ .............. ASTM F2255-05 (Reapproved 2015) Reaffirmation. Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading. 8-115............................ .............. ASTM F2256-05 (Reapproved 2015) Reaffirmation. Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading. 8-116............................ .............. ASTM F2258-05 (Reapproved 2015) Reaffirmation. Standard Test Method for Strength Properties of Tissue Adhesives in Tension. 8-121............................ .............. ASTM F2005-05 (Reapproved 2015) Reaffirmation. Standard Terminology for Nickel- Titanium Shape Memory Alloys. 8-134............................ 8-392 ASTM F2082-15 Standard Test Withdrawn and replaced with Method for Determination of newer version. Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery. 8-135............................ .............. ASTM F2392-04 (Reapproved 2015) Reaffirmation. Standard Test Method for Burst Strength of Surgical Sealants. 8-136............................ .............. ASTM F2458-05 (Reapproved 2015) Reaffirmation. Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants. 8-167............................ 8-393 ASTM F1350-15 Standard Withdrawn and replaced with Specification for Wrought newer version. 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673). 8-168............................ 8-394 ASTM F1472-14 Standard Withdrawn and replaced with Specification for Wrought newer version. Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400). 8-170............................ 8-395 ASTM F961-14 Standard Withdrawn and replaced with Specification for 35Cobalt- newer version. 35Nickel-20Chromium- 10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035). 8-177............................ 8-396 ASTM F2129-15 Standard Test Withdrawn and replaced with Method for Conducting Cyclic newer version. Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. 8-179............................ .............. ASTM F754-08 (Reapproved 2015) Reaffirmation. Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders. 8-184............................ 8-397 ASTM F2516-14 Standard Test Withdrawn and replaced with Method for Tension Testing of newer version. Nickel-Titanium Superelastic Materials. 8-189............................ 8-398 ASTM F1108-14 Standard Withdrawn and replaced with Specification for Titanium- newer version. 6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406). 8-190............................ 8-399 ASTM F90-14 Standard Withdrawn and replaced with Specification for Wrought newer version. Cobalt-20Chromium-15Tungsten- 10Nickel Alloy for Surgical Implant Applications (UNS R30605). 8-192............................ 8-400 ASTM F1854-15 Standard Test Withdrawn and replaced with Method for Stereological newer version. Evaluation of Porous Coatings on Medical Implants. 8-200............................ .............. ASTM F2003-02 (Reapproved 2015) Reaffirmation. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. 8-204............................ 8-401 ASTM F2118-14 Standard Test Withdrawn and replaced with Method for Constant Amplitude newer version. of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials. [[Page 19200]] 8-206............................ 8-402 ASTM F688-14 Standard Withdrawn and replaced with Specification for Wrought newer version. Cobalt-35Nickel-20Chromium 10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035). 8-225............................ .............. ASTM F2003-02 (Reapproved 2015) Withdrawn. See 8-200. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. 8-363............................ 8-403 ASTM D638-14 Standard Test Withdrawn and replaced with Method for Tensile Properties newer version. of Plastics. 8-367............................ 8-404 ASTM E647-15 Standard Test Withdrawn and replaced with Method for Measurement of newer version. Fatigue Crack Growth Rates. 8-369............................ .............. ASTM F2003-02 (Reapproved 2015) Withdrawn. See 8-200. Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. 8-386............................ 8-405 ISO 5832-4 Third Edition 2014-09- Withdrawn and replaced with 15 Implants for surgery-- newer version. Metallic materials--Part 4: Cobalt-chromium-molybdenum casting alloy. 8-387............................ 8-406 ISO 5832-11 Second Edition 2014- Withdrawn and replaced with 09-15 Implants for surgery-- newer version. Metallic materials--Part 11: Wrought titanium 6-aluminium 7- niobium alloy. ---------------------------------------------------------------------------------------------------------------- J. Nanotechnology ---------------------------------------------------------------------------------------------------------------- 18-1............................. .............. ASTM E2490-09 (Reapproved 2015) Reaffirmation. Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS). ---------------------------------------------------------------------------------------------------------------- K. Obstetrics-Gynecology (OB-GYN)/Gastroenterology ---------------------------------------------------------------------------------------------------------------- 9-61............................. .............. IEC 60601-2-18 Edition 3.0 2009- Withdrawn. Merged with 4- 08 Medical Electrical 187. Equipment--Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. 9-83............................. 9-110 ISO 8600-1 Fourth Edition 2015- Withdrawn and replaced with 10-15 Endoscopes--Medical newer version. endoscopes and endotherapy devices--Part 1: General requirements. 9-96............................. .............. CEN EN 1618:1997 Catheters Other Duplicate recognition Than Intravascular Catheters-- number. See 9-113. Test Methods for Common Properties. 9-102............................ 9-111 ISO 4074 Third Edition 2015-10- Withdrawn and replaced with 15 Natural rubber latex male newer version. condoms--Requirements and test methods. 9-109............................ 9-112 ASTM D3492-15 Standard Withdrawn and replaced with Specification for Rubber newer version. Contraceptives (Male Condoms). ---------------------------------------------------------------------------------------------------------------- L. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-73............................ .............. ANSI Z80.21-2010 (R2015) Reaffirmation. Ophthalmics--Instruments--Gener al-Purpose Clinical Visual Acuity Charts. ---------------------------------------------------------------------------------------------------------------- M. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-207........................... 11-296 ASTM F2193-14 Standard Withdrawn and replaced with Specifications and Test Methods newer version. for Components Used in the Surgical Fixation of the Spinal Skeletal System. 11-214........................... 11-297 ASTM F382--14 Standard Withdrawn and replaced with Specification and Test Method newer version. for Metallic Bone Plates. 11-216........................... 11-298 ASTM F1264--14 Standard Withdrawn and replaced with Specification and Test Methods newer version. for Intramedullary Fixation Devices. 11-220........................... 11-299 ASTM F2068--15 Standard Withdrawn and replaced with Specification for Femoral newer version. Prostheses--Metallic Implants. 11-227........................... .............. ASTM F366-10 (Reapproved 2015) Reaffirmation. Standard Specification for Fixation Pins and Wires. 11-228........................... .............. ASTM F564-10 (Reapproved 2015) Reaffirmation. Standard Specification and Test Methods for Metallic Bone Staples. 11-247........................... .............. ASTM F2789-10 (Reapproved 2015) Reaffirmation. Standard Guide for Mechanical and Functional Characterization of Nucleus Devices. 11-256........................... .............. ISO 14243-3 First Edition 2004- Withdrawn. See 11-292. 09-25 Implants for surgery-- Wear of total knee-joint prostheses--Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: Technical Corrigendum 1(2006)]. 11-262........................... 11-301 ASTM F2091-15 Standard Withdrawn and replaced with Specification for Acetabular newer version. Prostheses. [[Page 19201]] 11-278........................... 11-302 ASTM F1717-15 Standard Test Withdrawn and replaced with Methods for Spinal Implant newer version. Constructs in a Vertebrectomy Model. ---------------------------------------------------------------------------------------------------------------- N. Physical Medicine ---------------------------------------------------------------------------------------------------------------- 16-158........................... 16-195 ISO 7176-1 Third Edition 2014-10- Withdrawn and replaced with 01 Wheelchairs--Part 1: newer version. Determination of static stability. ---------------------------------------------------------------------------------------------------------------- O. Radiology ---------------------------------------------------------------------------------------------------------------- 12-139........................... .............. NEMA UD 2-2004 (R2009) Acoustic Reaffirmation. output measurement standard for diagnostic ultrasound equipment, Revision 3. 12-187........................... .............. NEMA MS 3-2008 (R2014) Reaffirmation. Determination of Image Uniformity in Diagnostic Magnetic Resonance Images. 12-188........................... .............. NEMA MS 1-2008 (R2014) Reaffirmation. Determination of Signal-to- Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. 12-195........................... .............. NEMA MS 6-2008 (R2014) Reaffirmation. Determination of Signal-to- Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI). 12-196........................... .............. NEMA MS 2-2008 (R2014) Reaffirmation. Determination of Two- Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images. 12-207........................... .............. IEC 60601-2-33 Ed. 3.0 2010 Extent of recognition. Medical electrical equipment-- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 12-209........................... 12-293 IEC 60601-2-37 Ed. 2.1 b:2015 Withdrawn and replaced with Medical electrical equipment-- newer version. Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. 12-236........................... 12-294 IEC 60601-2-45 Ed. 3.1 b:2015 Withdrawn and replaced with Medical electrical equipment-- newer version. Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. 12-257........................... 12-297 ISO 2919 Third Edition 2012-02- Duplicate recognition 15 Radiation protection--Sealed number. See 12-297. radioactive sources--General requirements and classification. 12-271........................... 12-295 IEC 60601-2-33 Ed. 3.2 b:2015 Withdrawn and replaced with Medical electrical equipment-- newer version. Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 12-274........................... 12-296 IEC 60601-2-54 Ed. 1.1 b:2015 Withdrawn and replaced with Medical electrical equipment-- newer version. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. 12-288........................... .............. NEMA MS 9-2008 (R2014) Reaffirmation. Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI). ---------------------------------------------------------------------------------------------------------------- P. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-8............................. 13-79 IEC 62304 Edition 1.1 2015-06 Withdrawn and replaced with Medical device software-- newer version. Software life cycle processes. 13-50............................ 13-80 IEEE Std. 11073-20601: 2014 Withdrawn and replaced with Health informatics--Personal newer version. health device communication-- Part 20601: Application profile--Optimized Exchange Protocol [including: Corrigendum 1 (2015)]. 13-51............................ .............. IEEE Std. 11073-20601a-2010 Withdrawn. See 13-80. Health informatics--Personal health device communication-- Part 20601: Application profile--Optimized Exchange Protocol Amendment 1. ---------------------------------------------------------------------------------------------------------------- Q. Sterility ---------------------------------------------------------------------------------------------------------------- 14-227........................... .............. ANSI/AAMI/ISO 11737-1:2006 Extent of recognition. (R)2011 Sterilization of health care products--Microbiological methods--Part 1: Determination of the population of microorganisms on product. 14-261........................... .............. ANSI/AAMI/ISO 17665-1:2006/ Extent of recognition. (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. 14-277........................... .............. ISO/TS 17665-2 First Edition Extent of recognition. 2009-01-15 Sterilization of health care products--Moist heat--Part 2: Guidance on the application of ISO 17665-1. 14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Extent of recognition. (R)2014 Sterilization of medical devices-- Microbiological methods--Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process. [[Page 19202]] 14-291........................... .............. ANSI/AAMI/ISO 14937:2009/(R)2013 Extent of recognition. 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. 14-296........................... .............. ANSI/AAMI/ISO 11138-1:2006/ Extent of recognition. (R)2010 Sterilization of health care products--Biological indicators--Part 1: General requirements. 14-298........................... .............. ANSI/AAMI/ISO 11137-3:2006/ Extent of recognition. (R)2010 Sterilization of health care products--Radiation--Part 3: Guidance on dosimetric aspects. 14-327........................... .............. ISO 11737-2 Second Edition 2009- Extent of recognition. 11-15 Sterilization of medical devices--Microbiological methods--Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process. 14-330........................... .............. ISO 11137-3 First Edition 2006- Extent of recognition. 04-15 Sterilization of health care products--Radiation--Part 3: Guidance on dosimetric aspects. 14-333........................... .............. ISO 17665-1 First Edition 2006- Extent of recognition. 08-15 Sterilization of health care products--Moist heat--Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-337........................... .............. ISO 14937 Second Edition 2009-10- Extent of recognition. 15 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 devices. 14-338........................... .............. ISO 11138-1 Second Edition 2006- Extent of recognition. 07-01 Sterilization of health care products--Biological indicators--Part 1: General requirements. 14-339........................... .............. ANSI/AAMI/ISO 20857:2010 Extent of recognition. Sterilization of health care products--Dry heat-- Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-340........................... .............. ISO 20857 First Edition 2010-08- Extent of recognition. 15 Sterilization of health care products--Dry heat-- Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Reaffirmation. (R)2015 Aseptic processing of health care products--Part 3: Lyophilization. 14-351........................... .............. ANSI/AAMI/ISO 13408-5:2006/ Reaffirmation. (R)2015 Aseptic processing of health care products--Part 5: Sterilization in place. 14-376........................... .............. ANSI/AAMI/ISO TIR17665-2:2009 Extent of recognition. Sterilization of health care products--Moist heat--Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1. 14-407........................... .............. ISO 11737-1 Second Edition 2006- Extent of recognition. 04-01 Sterilization of medical devices--Microbiological methods--Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]. 14-409........................... .............. ISO 11137-2 Third Edition 2013- Extent of recognition. 06-01 Sterilization of health care products--Radiation--Part 2: Establishing the sterilization dose. 14-428........................... .............. ISO 11137-1 First Edition 2006- Extent of recognition. 04-15 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)]. 14-438........................... .............. ANSI/AAMI/ISO 11137-2:2013 Extent of recognition. Sterilization of health care products--Radiation--Part 2: Establishing the sterilization dose. 14-452........................... .............. ISO 11135 Second Edition 2014, Extent of recognition. Sterilization of health care products--Ethylene oxide-- Requirements for development, validation, and routine control of a sterilization process for medical devices. 14-461........................... .............. ANSI/AAMI/ISO 11137-1:2006/(R) Extent of recognition. 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)]. ---------------------------------------------------------------------------------------------------------------- R. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-8............................. 15-42 ASTM F2064-14 Standard Guide for Withdrawn and replaced with Characterization and Testing of newer version. Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications. 15-22............................ 15-43 ASTM F2791-15 Standard Guide for Withdrawn and replaced with Assessment of Surface Texture newer version. of Non-Porous Biomaterials in Two Dimensions. 15-24............................ .............. ASTM F2721-09 (Reapproved 2014) Reaffirmation. Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects. ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. [[Page 19203]] 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: 041. Table 2--New Entries to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Recognition No. Title of standard \1\ Reference No. and date ---------------------------------------------------------------------------------------------------------------- A. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-107............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5356-1:2004. Equipment--Conical Connectors-- Part 1: Cones and Sockets. 1-108............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5361:2012. Equipment--Tracheal Tubes and Connectors. 1-109............................ Anaesthetic Reservoir Bags....... ANSI/AAMI/ISO 5362:2006. 1-110............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5366-1:2000. Equipment--Tracheostomy Tubes-- Part 1: Tubes and Connectors for Use in Adults. 1-111............................ Anaesthetic and Respiratory ANSI/AAMI/ISO 5366-3:2001. Equipment--Tracheostomy Tubes-- Part 3: Paediatric Tracheostomy Tubes. 1-112............................ Lung Ventilators--Part 4: ANSI/AAMI/ISO 10651-4:2002. Particular Requirements for Operator-Powered Resuscitators. 1-113............................ Lung Ventilators for Medical Use-- ANSI/AAMI/ISO 10651-5:2006. Particular Requirements for Basic Safety and Essential Performance--Part 5: Gas-powered Emergency Resuscitators. 1-114............................ Inhalational Anaesthesia Systems-- ISO 18835 First Edition 2015-04-01. Draw-over Anaesthetic Systems. 1-115............................ Medical Electrical Equipment-- ISO 80601-2-70 First Edition 2015-01-15. Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-223............................ Standard Guide for Selecting ASTM F2901-13. Tests to Evaluate Potential Neurotoxicity of Medical Devices. 2-225............................ Standard Practice for Testing for ASTM F2567-06 (Reapproved 2010). Classical Complement Activation in Serum By Solid Materials. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-140............................ Cardiovascular implants--Cardiac ANSI/AAMI/ISO 5840-3: 2013. valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques. 3-141............................ Implants for surgery--Cardiac ANSI/AAMI/ISO 5841-3: 2013. pacemakers--Part 3: Low-profile connectors (IS-1) for implantable pacemakers. ---------------------------------------------------------------------------------------------------------------- D. Dental/ENT ---------------------------------------------------------------------------------------------------------------- 4-226............................ Dentistry--Powered polymerization ISO 10650 First Edition 2015-09-01. activators. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management) ---------------------------------------------------------------------------------------------------------------- 5-100............................ Small-bore connectors for liquids ANSI/AAMI/ISO 80369-20:2015. and gases in healthcare applications--Part 20: Common test methods. 5-101............................ Small-bore connectors for liquids AAMI/CN6:2015. and gases in healthcare applications--Part 6: Connectors for neuraxial applications. ---------------------------------------------------------------------------------------------------------------- F. General II (ES/EMC) ---------------------------------------------------------------------------------------------------------------- 19-17............................ American National Standard ANSI/IEEE C63.18-2014. Recommended Practice for an On- Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters. 19-18............................ Safety requirements for IEC 61010-1 Edition 3.0 2010-06. electrical equipment for measurement, control, and laboratory use--Part 1: General requirements [Including: Corrigendum 1 (2011)]. ---------------------------------------------------------------------------------------------------------------- [[Page 19204]] G. GH/GPS ---------------------------------------------------------------------------------------------------------------- 6-357............................ Intravascular Catheters--Sterile ISO 10555-6 First Edition 2015-04-15. and Single-use Catheters--Part 6: Subcutaneous Implanted Ports. 6-358............................ Infusion Equipment for Medical ISO 8536-8 Second Edition 2015-06-15. Use--Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus. 6-359............................ Infusion Equipment for Medical ISO 8536-9 Second Edition 2015-06-15. Use--Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment. 6-360............................ Infusion Equipment for Medical ISO 8536-10 Second Edition 2015-06-15. Use--Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment. 6-361............................ Infusion Equipment for Medical ISO 8536-11 Second Edition 2015-06-15. Use--Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment. ---------------------------------------------------------------------------------------------------------------- H. Materials ---------------------------------------------------------------------------------------------------------------- 8-407............................ Standard Specification for ISO/ASTM 52915 First Edition 2013-06-01. Additive Manufacturing File Format (AMF) Version 1.1. 8-408............................ Standard Guide for Evaluating ASTM F3122-14. Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes. 8-409............................ Standard Specification for ASTM F2924-14. Additive Manufacturing Titanium- 6 Aluminum-4 Vanadium with Powder Bed Fusion. 8-410............................ Standard Guide for Assessment of ASTM F2902-12. Absorbable Polymeric Implants. 8-411............................ Specification for Amorphous ASTM F2579-10. Poly(lactide) and Poly(lactide- co-glycolide) Resins for Surgical Implants. 8-412............................ Standard Practice for Calibration ASTM F2537-06 (Reapproved 2011). of Linear Displacement Sensor Systems Used to Measure Micromotion. 8-413............................ Standard Test Methods for ASTM F2819-10 (Reapproved 2015). Measurement of Straightness of Bar, Rod, Tubing, and Wire to be used for Medical Devices. 8-414............................ Standard Practice for Reporting ASTM F2847-10. and Assessment of Residues on Single Use Implants. 8-415............................ Standard Test Method for ASTM F2778-09 (Reapproved 2015). Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR).. 8-416............................ Standard Test Method for Small ASTM F2977-13. Punch Testing of Polymeric Biomaterials Used in Surgical Implants. 8-417............................ Test Method for Standard Test ASTM F3044-14. Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants. 8-418............................ Standard Test Methods for ASTM F640-12. Determining Radiopacity for Medical Use. 8-419............................ Standard Specification for Metal ASTM F2885-11. Injection Molded Titanium-6 Aluminum-4 Vanadium Components for Surgical Implant Applications. 8-420............................ Standard Specification for Metal ASTM F2886-10. Injection Molded Cobalt-28 Chromium-6 Molybdenum Components for Surgical Implant Applications. ---------------------------------------------------------------------------------------------------------------- I. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-100........................... Ophthalmic optics--Contact lens ISO 18259 First Edition 2014-10-01. care products--Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms. ---------------------------------------------------------------------------------------------------------------- J. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-303........................... Standard Guide for High Demand ASTM F3047M-15. Hip Simulator Wear Testing of Hard-on-hard Articulations. [[Page 19205]] 11-304........................... Measuring Accuracy after ASTM F3107-14. Mechanical Disturbances. ---------------------------------------------------------------------------------------------------------------- K. Physical Medicine ---------------------------------------------------------------------------------------------------------------- 16-196........................... Wheelchairs--Part 7: Measurement ISO 7176-7 First Edition 1998-05-15. of seating and wheel dimensions. 16-197........................... Wheelchairs--Part 8: Requirements ISO 7176-8 Second Edition 2014-12-15. and test methods for static, impact, and fatigue strengths. 16-198........................... Wheelchairs--Part 22: Set-up ISO 7176-22 Second Edition 2014-09-01. procedures. ---------------------------------------------------------------------------------------------------------------- L. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-81............................ Health informatics--Personal IEEE Std. 11073-10419: 2015. health device communication-- Part 10419: Device Specialization--Insulin Pump. ---------------------------------------------------------------------------------------------------------------- M. Sterility ---------------------------------------------------------------------------------------------------------------- 14-479........................... Sterilization of health care ANSI/AAMI/ISO 11135:2014. products--Ethylene oxide-- Requirements for development, validation, and routine control of a sterilization process for medical devices. ---------------------------------------------------------------------------------------------------------------- N. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-44............................ Standard Guide for in vivo ASTM F2529-13. Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) Active Standard. ---------------------------------------------------------------------------------------------------------------- \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 FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register, once a year or more often if necessary. Beginning with Recognition List: 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for 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. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 041'' will be available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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. Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-07467 Filed 4-1-16; 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 April 4, 2016. | |
| Contact | Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287, [email protected] | |
| FR Citation | 81 FR 19196 |