| Page Range | 48871-48879 | |
| FR Document | 2015-19991 |
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)] [Notices] [Pages 48871-48879] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19991] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451; formerly Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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: 040'' (Recognition List Number: 040), 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. See section VII for the effective date of the recognition of standards announced in this document. ADDRESSES: An electronic copy of Recognition List Number: 040 is available on the Internet at http:// [[Page 48872]] www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ ucm123792.htm. See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 040 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: 040'' 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. Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains HTML and PDF versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 040 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: 040'' 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 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 ---------------------------------------------------------------------------------------------------------------- 1-46............................. 1-103 ISO 5367 Fifth edition 2014-10- Withdrawn and replaced with 15 Anaesthetic and respiratory newer version. equipment--Breathing sets and connectors. 1-82............................. .............. IEC 60601-2-13 Edition 3.1 2009- Withdrawn. See 1-104. 08, Medical electrical equipment--Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-179............................ 2-220 ISO 10993-1 Fourth edition 2009- Withdrawn and replaced with 10-15 Biological evaluation of newer version including medical devices--Part 1:. Technical Corrigendum. Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)]. 2-208............................ 2-215 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with Reactivity Test, In Vitro-- newer version. Direct Contact Test. 2-209............................ 2-216 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with Reactivity Test, In Vitro-- newer version. Elution Test. 2-210............................ 2-217 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with Reactivity Tests, In Vivo, newer version. Procedure Preparation of Sample. 2-211............................ 2-218 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with Reactivity Test, In Vitro, newer version. Classification of Plastics-- Intracutaneous Test. 2-212............................ 2-219 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with Reactivity Tests, In Vivo, newer version. Classification of Plastics-- Systemic Injection Test. ---------------------------------------------------------------------------------------------------------------- [[Page 48873]] C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-76............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177. Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine The Corrosion Susceptibility of Small Implant Devices. 3-117............................ .............. ANSI/AAMI/ISO 81060-2:2013 Non- Extent of recognition. invasive sphygmomanometers-- Part 2: Clinical validation of automated measurement type. 3-122............................ .............. ISO 81060-2 Second edition 2013- Extent of recognition. 05-01 Non-invasive sphygmomanometers--Part 2: Clinical validation of automated measurement type. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-105............................ .............. ANSI/ADA Standard No.75 Reaffirmation. (Reaffirmed by ANSI: September 8, 2014) Resilient Lining Materials For Removable Dentures, Part 1: Short-Term Materials. 4-130............................ .............. ANSI/ADA Standard No. 17 Reaffirmation. (Reaffirmed by ANSI: September 8, 2014) Denture Base Temporary Relining Resins. 4-150............................ .............. ANSI/ADA Specification No. 19- Reaffirmation. 2004/ISO 4823:2000 (Reaffirmed by ANSI: October 6, 2014) Dental Elastomeric Impression Materials. 4-184............................ .............. ANSI/ASA S3.25-2009 (Revision of Reaffirmation. ANSI S3.25-1989) (Reaffirmed by ANSI September 11, 2014) American National Standard For an Occluded Ear Simulator. 4-191............................ 4-220 ANSI/ASA S3.22-2014 AMERICAN Withdrawn and replaced with NATIONAL STANDARD Specification newer version. of Hearing Aid Characteristics. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management (QS/RM)) ---------------------------------------------------------------------------------------------------------------- 5-67............................. .............. ANSI/AAMI/IEC 62366:2007/(R)2013 Withdrawn. See 5-96. Medical devices--Application of usability engineering to medical devices. 5-87............................. .............. IEC 62366 Edition 1.1 2014-01 Withdrawn. See 5-95. Medical devices--Application of usability engineering to medical devices. 5-94............................. .............. AAMI/CN20 (PS):2014 Small-bore Withdrawn. See 5-97. connectors for liquids and gases in healthcare applications--Part 20: Common test methods. ---------------------------------------------------------------------------------------------------------------- F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC)) ---------------------------------------------------------------------------------------------------------------- 19-6............................. .............. IEC 60601-1-11 Edition 1.0 2010- Transition Period Added. 04 Medical 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 [Including: Technical Corrigendum 1 (2011)]. ---------------------------------------------------------------------------------------------------------------- G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-110............................ .............. ASTM F1441-03 (Reapproved 2014) Reaffirmation. Standard Specification for Soft- Tissue Expander Devices. 6-185............................ .............. ASTM F881-94 (Reapproved 2014) Reaffirmation. Standard Specification for Silicone Elastomer Facial Implants. 6-200............................ .............. ASTM E1061-01 (Reapproved 2014) Reaffirmation. Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers. 6-274............................ 6-341 ISO 11608-1 Third Edition 2014- Withdrawn and replaced with 12-15 Needle-based injection newer version. systems for medical use-- Requirements and test methods-- Part 1: Needle-based injection systems. 6-301............................ .............. ISO 10555-1 Second Edition 2013- Extent of Recognition. 07-01 Sterile, single-use intravascular catheters--Part 1: General requirements. 6-308............................ 6-342 IEC 80601-2-35 Edition 2.0 2009- Withdrawn and replaced with 10 Medical electrical newer version including equipment--Part 2-35: Technical Corrigendum. 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: Technical Corrigendum 1 (2012) and Technical Corrigendum 2 (2015)]. 6-326............................ 6-343 USP 38-NF 33:2015 Sodium Withdrawn and replaced with Chloride Irrigation. newer version. 6-327............................ 6-344 USP 38-NF 33:2015 Sodium Withdrawn and replaced with Chloride Injection. newer version. 6-328............................ 6-345 USP 38-NF33:2015 Nonabsorbable Withdrawn and replaced with Surgical Suture. newer version. 6-329............................ 6-346 USP 38-NF33:2015 <881> Tensile Withdrawn and replaced with Strength. newer version. [[Page 48874]] 6-330............................ 6-347 USP 38-NF33:2015 <861> Sutures-- Withdrawn and replaced with Diameter. newer version. 6-331............................ 6-348 USP 38-NF33:2015 <871> Sutures-- Withdrawn and replaced with Needle Attachment. newer version. 6-332............................ 6-349 USP 38-NF33:2015 Sterile Water Withdrawn and replaced with for Irrigation. newer version. 6-333............................ 6-350 USP 38-NF33:2015 Heparin Lock Withdrawn and replaced with Flush Solution. newer version. 6-334............................ 6-351 USP 38-NF33:2015 Absorbable Withdrawn and replaced with Surgical Suture. newer version. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-110............................ 7-251 CLSI EP05-A3 Evaluation of Withdrawn and replaced with Precision Performance of newer version. Quantitative Measurement Methods; Approved Guideline- Third Edition. 7-143............................ 7-252 CLSI EP14-A3 Evaluation of Withdrawn and replaced with Matrix Effects; Approved newer version. Guideline--Third Edition. 7-153............................ 7-253 CLSI EP15-A3 User Verification Withdrawn and replaced with of Performance for Precision newer version. and Estimation of Bias; Approved Guideline-Third Edition. 7-230............................ 7-254 CLSI M07-A10 Methods for Withdrawn and replaced with Dilution Antimicrobial newer version. Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard--Ninth Edition. 7-123............................ 7-255 CLSI MM09-A2 Nucleic Acid Withdrawn and replaced with Sequencing Methods in newer version. Diagnostic Laboratory Medicine; Approved Guideline--Second Edition. 7-247............................ 7-256 CLSI M100-S25 Performance Withdrawn and replaced with Standards for Antimicrobial newer version. Susceptibility Testing; Twenty- Fifth Informational Supplement. ---------------------------------------------------------------------------------------------------------------- I. Materials ---------------------------------------------------------------------------------------------------------------- 8-59............................. 8-386 ISO 5832-4 Third edition 2014-09- Withdrawn and replaced 15 Implants for surgery-- newer version. Metallic materials--Part 4: Cobalt-chromium-molybdenum casting alloy. 8-63............................. 8-387 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. 8-177............................ .............. ASTM F2129-08 Standard Test Updated to incorporate Method for Conducting Cyclic transferred recognitions 3- Potentiodynamic Polarization 76 and 17-9. Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. ---------------------------------------------------------------------------------------------------------------- J. Neurology ---------------------------------------------------------------------------------------------------------------- 17-9............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177. Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices. 17-4............................. .............. ASTM F647-94(2014) Standard Reaffirmation. Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. ---------------------------------------------------------------------------------------------------------------- K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology ---------------------------------------------------------------------------------------------------------------- 9-73............................. 9-104 ANSI/AAMI/ISO 13958:2014 Withdrawn and replaced with Concentrates for hemodialysis newer version. and related therapies. 9-97............................. .............. ISO 13958 Third edition 2014-04- Extent of recognition. 01 Concentrates for haemodialysis and related therapies. 9-69............................. 9-105 ANSI/AAMI 13959:2014 Water for Withdrawn and replaced with hemodialysis and related newer version. therapies. 9-100............................ .............. ISO 11663 Second edition 2014-04- Extent of recognition. 01 Quality of dialysis fluid for haemodialysis and related therapies. 9-71............................. 9-106 ANSI/AAMI/ISO 11663:2014 Quality Withdrawn and replaced with of dialysis fluid for newer version. hemodialysis and related therapies. 9-70............................. 9-107 ANSI/AAMI 23500:2014 Guidance Withdrawn and replaced with for the preparation and quality newer version. management of fluids for hemodialysis and related therapies. 9-102............................ .............. ISO 4074 Second edition 2014-08- Extent of recognition. 15 Natural latex rubber condoms--Requirements and test methods. 9-90............................. 9-108 ISO 8009 Second edition 2014-11- Withdrawn and replaced with 15 Mechanical contraceptives-- newer version. Reusable natural and silicone rubber contraceptive diaphragms--Requirements and tests. 9-56............................. 9-109 ASTM D3492-08 Standard Withdrawn and replaced with Specification for Rubber newer version. Contraceptives (Male Condoms). ---------------------------------------------------------------------------------------------------------------- [[Page 48875]] L. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-29............................ 10-94 ISO 14730 Second edition 2014-10- Withdrawn and replaced with 01 Ophthalmic Optics--Contact newer version. lens care products-- antimicrobial preservative efficacy testing and guidance on determining discard date. 10-55............................ 10-95 ISO 11979-6 Third edition 2014- Withdrawn and replaced with 10-01 Ophthalmic implants-- newer version. intraocular lenses--Part 6: Shelf-life and transport stability. 10-62............................ 10-96 ANSI Z80.10-2014 American Withdrawn and replaced with National Standard for newer version. Opthalmics Ophthalmic Instruments--Tonometers. 10-68............................ 10-97 ISO 13212 Third edition 2014-09- Withdrawn and replaced with 01 Ophthalmic Optics-Contact newer version. lens care products--Guidelines for determination of shelf-life. 10-82............................ 10-98 ISO 11979-2 Second edition 2014- Withdrawn and replaced with 08-15 Ophthalmic implants-- newer version. Intraocular lenses--Part 2: Optical properties and test methods. ---------------------------------------------------------------------------------------------------------------- M. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-240........................... 11-287 ASTM F382-14 Standard Withdrawn and replaced Specification and Test Method newer version. for Metallic Bone Plates. 11-235........................... 11-288 ASTM F2077-14 Test Methods for Withdrawn and replaced with Intervertebral Body Fusion newer version. Devices. 11-207........................... 11-289 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. 11-183........................... .............. ASTM F1875-98 (Reapproved 2014) Reaffirmation. Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface. 11-266........................... .............. ASTM F2665-09 (Reapproved 2014) Reaffirmation. Standard Specification for Total Ankle Replacement Prosthesis. 11-224........................... .............. ASTM F2706-08 (Reapproved 2014) Reaffirmation. Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.. 11-80............................ 11-290 ISO 8828 Second edition 2014-11- Withdrawn and replaced with 15 Implants for surgery-- newer version. Guidance on Care and Handling of Orthopaedic Implants. 11-248........................... 11-291 ISO 14242-1 Third edition 2014- Withdrawn and replaced with 10-15 Implants for surgery-- newer version. Wear of total hip-joint prostheses--Part 1: Loading and displacement parameters for wear testing machines and corresponding environmental conditions for test. 11-250........................... 11-292 ISO 14243-3 Second edition 2014- Withdrawn and replaced with 11-01 Implants for surgery-- newer version. Wear of total knee prostheses-- Part 3: Loading and displacement parameters for wear--testing machines with displacement control and corresponding environmental conditions for test. ---------------------------------------------------------------------------------------------------------------- N. Radiology ---------------------------------------------------------------------------------------------------------------- 12-102........................... .............. ANSI/IESNA RP-27.2-2000 Reaffirmation. (Reaffirmed 2011) Photobiological Safety for Lamp & Lamp Systems-Measurement Techniques. 12-212........................... 12-289 IEC 62220-1-1 Edition 1.0 2015- Withdrawn and replaced with 03 Medical electrical newer version. equipment--Characteristics of digital x-ray imaging devices-- Part 1-1: Determination of the detective quantum efficiency-- Detectors used in radiographic imaging. 12-229........................... 12-290 IEC 61910-1 Edition 1.0 2014-09 Withdrawn and replaced with Medical electrical equipment-- newer version. Radiation dose documentation-- Part 1: Radiation dose structured reports for radiography and radioscopy. 12-278........................... 12-291 IEC 62127-2 Edition 1.1 2013-02 Withdrawn and replaced with Ultrasonics Hydrophones--Part newer version. 2: Calibration for ultrasonic fields up to 40 MHz. ---------------------------------------------------------------------------------------------------------------- O. Sterility ---------------------------------------------------------------------------------------------------------------- 14-193........................... 14-457 ANSI/AAMI/ISO 11607-1:2006/ Withdrawn and replaced with (R)2010 Packaging for newer version including terminally sterilized medical Amendment. devices--Part 1: Requirements for materials, sterile barrier systems and packaging [Including: Amendment 1 (2014)]. 14-194........................... 14-458 ANSI/AAMI/ISO 11607-2:2006/ Withdrawn and replaced with (R)2010 Packaging for newer version including terminally sterilized medical Amendment. devices--Part 2: Validation requirements for forming, sealing and assembly processes[Including: Amendment 1 (2014)]. 14-195........................... 14-459 ANSI/AAMI/ISO 11140-1:2014 Withdrawn and replaced with Sterilization of health care newer version. products--Chemical indicators-- Part 1: General requirements. 14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Reaffirmation. (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 48876]] 14-297........................... 14-461 ANSI/AAMI/ISO 11137-1:2006/(R) Withdrawn and replaced with 2010 Sterilization Of Health newer version including Care Products--Radiation--Part Amendment. 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices [Including: Amendment 1 (2013)]. 14-300........................... 14-462 ASTM D4169--14 Standard Practice Withdrawn and replaced with for Performance Testing of newer version. Shipping Containers and Systems. 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. 14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Reaffirmation. (R)2014, Aseptic processing of health care products--Part 4: Clean-in-place technologies. 14-353........................... 14-460 ISO 11140-1 Third edition 2014- Withdrawn and replaced with 11-01 Sterilization of health newer version. care products--Chemical indicators--Part 1: General requirements. 14-391........................... 14-463 ISO/ASTM 51608 Third edition Withdrawn and replaced with 2015-03-15 Practice for newer version. dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV. 14-392........................... 14-464 ISO/ASTM 51649 Third edition Withdrawn and replaced with 2015-03-15 Practice for newer version. dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV. 14-431........................... 14-465 ISO/ASTM 51707 Third edition Withdrawn and replaced with 2015-03-15 Guide for estimation newer version. of measurement uncertainty in dosimetry for radiation processing. 14-440........................... 14-466 USP 38-NF33:2015 <61> Withdrawn and replaced with Microbiological Examination of newer version. Nonsterile Products: Microbial Enumeration Tests. 14-441........................... 14-467 USP 38-NF33:2015 <71> Sterility Withdrawn and replaced with Tests. newer version. 14-442........................... 14-468 USP 38-NF33:2015 <85> Bacterial Withdrawn and replaced with Endotoxins Test. newer version. 14-443........................... 14-477 USP 38-NF33:2015 <151> Pyrogen Withdrawn and replaced with Test (USP Rabbit Test). newer version. 14-444........................... 14-469 USP 38-NF33:2015 <161> Withdrawn and replaced with Transfusion and Infusion newer version. Assemblies and Similar Medical Devices. 14-445........................... 14-470 USP 38-NF33:2015 Biological Withdrawn and replaced with Indicator for Steam newer version. Sterilization--Self Contained. 14-446........................... 14-471 USP 38-NF33:2015 Biological Withdrawn and replaced with Indicator for Dry-Heat newer version. Sterilization, Paper Carrier. 14-447........................... 14-472 USP 38-NF33:2015 Biological Withdrawn and replaced with Indicator for Ethylene Oxide newer version. Sterilization, Paper Carrier. 14-448........................... 14-473 USP 38-NF33:2015 Biological Withdrawn and replaced with Indicator for Steam newer version. Sterilization, Paper Carrier. 14-449........................... 14-474 USP 38-NF33:2015 <62> Withdrawn and replaced with Microbiological Examination of newer version. Nonsterile Products: Tests for Specified Microorganisms. 14-450........................... 14-475 USP 38-NF33:2015 <55> Biological Withdrawn and replaced with Indicators--Resistance newer version. Performance Tests. 14-451........................... 14-476 USP 38-NF33:2015 <1035> Withdrawn and replaced with Biological Indicators for newer version. Sterilization. ---------------------------------------------------------------------------------------------------------------- \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: 040. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. and Recognition No. Title of standard \1\ date ------------------------------------------------------------------------ A. Anesthesia ------------------------------------------------------------------------ 1-104.................... Medical electrical ISO 80601-2-13 equipment--Part 2-13: First Edition 2011- Particular Requirements 08-01 and for basic safety and Amendment 1 2015. essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)]. 1-105.................... Medical electrical ISO 80601-2-72 equipment--Part 2-72: First Edition 2015- Particular requirements 04-11. for basic safety and essential performance of home healthcare environment ventilators for ventilator- dependent patients. ------------------------------------------------------------------------ [[Page 48877]] B. Biocompatibility ------------------------------------------------------------------------ 2-221.................... Biological Evaluation of ANSI/AAMI/ISO 10993- Medical Devices: Part 2:2006 (R2014). 2--Animal Welfare Requirements. 2-222.................... Biological Evaluation of ISO 10993-2 Second Medical Devices: Part edition 2006-07- 2--Animal Welfare 15. Requirements. ------------------------------------------------------------------------ C. Cardiovascular ------------------------------------------------------------------------ 3-135.................... Cardiovascular implants ISO/TS 12417-1 and extracorporeal First edition 2011- systems--Vascular 06-01. device-drug combination products. 3-136.................... Cardiovascular implants ANSI/AAMI/ISO and extracorporeal TIR12417:2011. systems--Vascular device-drug combination products. 3-137.................... Standard Guide for ASTM F3036-13. Testing Absorbable Stents. 3-138.................... Standard Guide for in ASTM F2942-13. vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents. 3-139.................... Active implantable ISO 14117 First medical devices-- edition 2012-07- Electromagnetic 15. compatibility--EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices. ------------------------------------------------------------------------ D. General I (Quality Systems/Risk Management) ------------------------------------------------------------------------ 5-95..................... Medical devices--Part 1: IEC 62366-1 Edition Application of 1.0 2015-02. usability engineering to medical devices. 5-96..................... Medical devices--Part 1: ANSI/AAMI/IEC 62366- Application of 1:2015. usability engineering to medical devices. 5-97..................... Small-bore connectors ISO 80369-20 First for liquids and gases edition 2015-05- in healthcare 15. applications--Part 20: Common test methods. ------------------------------------------------------------------------ E. General II (ES/EMC) ------------------------------------------------------------------------ 19-14.................... Medical electrical IEC 60601-1-11 equipment--Part 1-11: Edition 2.0 2015- General requirements 01. for basic safety and essential performance-- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. 19-15.................... Medical electrical IEC 60601-1-12 equipment--Part 1-12: Edition 1.0 2014- General requirements 06. for basic safety and essential performance-- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. ------------------------------------------------------------------------ F. GH/GPS ------------------------------------------------------------------------ 6-352.................... Standard Specification ASTM F703-07. for Implantable Breast Prostheses. 6-353.................... Standard Specification ASTM F2051-00 for Implantable Saline (Reapproved 2014). Filled Breast Prosthesis. 6-354.................... Standard Specification ASTM D7866-14. for Radiation Attenuating Protective Gloves. ------------------------------------------------------------------------ G. IVD ------------------------------------------------------------------------ 7-257.................... Principles and CLSI M56-A. procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline. 7-258.................... Performance Standards CLSI M02-A12. for Antimicrobial Disk Susceptibility Tests; Approved Standards- Twelfth Edition. ------------------------------------------------------------------------ H. Materials ------------------------------------------------------------------------ 8-388.................... Implants for surgery-- ISO 6474-2 First Ceramic materials--Part edition 2012-04- 2: Composite materials 15. based on a high-purity alumina matrix with zirconia reinforcement. 8-389.................... Implants for surgery-- ISO 15309 First Differential scanning edition 2013-12- calorimetry of poly 01. ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices. 8-390.................... Standard Specification ASTM F1925-09. for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants. 8-391.................... Standard Specification ASTM F2313-10. for Poly(glycolide) and Poly(glycolide-co- lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal To 70% Glycolide. ------------------------------------------------------------------------ I. Nanotechnology ------------------------------------------------------------------------ 18-4..................... Technical Specification-- ISO/TS 80004-6 Nanotechnologies--Vocab First edition 2013- ulary--Part 6: Nano- 11-01. object characterization. ------------------------------------------------------------------------ J. Neurology ------------------------------------------------------------------------ 17-14.................... Transcutaneous ANSI/AAMI NS4:2013. electrical nerve stimulators. ------------------------------------------------------------------------ [[Page 48878]] K. OB-GYN-GU/Gastroenterology ------------------------------------------------------------------------ 9-103.................... Water treatment ANSI/AAMI equipment for 26722:2014. hemodialysis and related therapies. ------------------------------------------------------------------------ L. Ophthalmic ------------------------------------------------------------------------ 10-99.................... Anionic and non-ionic ISO 4311 First surface active agents-- edition 1979-06- Determination of 01. critical micellization concentration--Method by measuring surface tension with a plate, stirrup, or ring,. ------------------------------------------------------------------------ M. Orthopedic ------------------------------------------------------------------------ 11-293................... Standard Test Method for ASTM F2582-14. Impingement of Acetabular Prostheses. 11-294................... Standard Specification ASTM F1357-14. for Articulating Total Wrist Implants. 11-295................... Standard Practice for ASTM F2580-13. Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis. ------------------------------------------------------------------------ N. Physical Medicine ------------------------------------------------------------------------ 16-194................... Wheelchairs Part ISO 7176-25 First 25:Batteries and edition 2013-07- chargers for powered 15. wheelchairs. ------------------------------------------------------------------------ O. Radiology ------------------------------------------------------------------------ 12-292................... IEEE Recommended IEEE Std 3333.2.1- Practice for Three- 2015. Dimensional (3D) Medical Modeling. ------------------------------------------------------------------------ P. Software/Informatics ------------------------------------------------------------------------ 13-73.................... Systematized IHTSDO SNOME-CT RF2 Nomenclature of Release 2015. Medicine--Clinical Terms. 13-74.................... Health informatics-- IEEE Std 11073- Personal health device 10424-2014. communication, Part 10424: Device Specialization--Sleep Apnoea Breathing Therapy Equipment (SABTE). 13-75.................... Health informatics-- ISO/IEEE 11073- Point-of-care medical 10102 First device communication-- edition 2014-03- Part 10102: 01. Nomenclature--Annotated ECG. 13-76.................... Health informatics-- ISO 11073-91064 Standard communication First edition 2009- protocol--Part 91064: 05-01. Computer-assisted electrocardiography. 13-77.................... Information technology-- ISO/IEC 29147 First Security techniques-- edition 2014-02- Vulnerability 15. disclosure. 13-78.................... Information technology-- ISO/IEC 30111 First Security techniques-- edition 2013-11- Vulnerability handling 01. processes. ------------------------------------------------------------------------ Q. Sterility ------------------------------------------------------------------------ 14-478................... Flexible and semi-rigid ANSI/AAMI endoscope processing in ST91:2015. health care facilities. ------------------------------------------------------------------------ \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 [[Page 48879]] Recognized Standards, Recognition List Number: 040'' 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. VII. Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 040. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: August 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19991 Filed 8-13-15; 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. See section VII for the effective date of the recognition of standards announced in this document. | |
| 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 | 80 FR 48871 |