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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040

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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://Start Printed Page 48872www.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.

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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, standards@cdrh.fda.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (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

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Anesthesia
1-461-103ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment—Breathing sets and connectorsWithdrawn and replaced with newer version.
1-82IEC 60601-2-13 Edition 3.1 2009-08, Medical electrical equipment—Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsWithdrawn. See 1-104.
B. Biocompatibility
2-1792-220ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices—Part 1: Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)]Withdrawn and replaced with newer version including Technical Corrigendum.
2-2082-215USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
2-2092-216USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
2-2102-217USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of SampleWithdrawn and replaced with newer version.
2-2112-218USP 38-NF33:2015 <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version.
2-2122-219USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version.
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C. Cardiovascular
3-76ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine The Corrosion Susceptibility of Small Implant DevicesTransferred. See 8-177.
3-117ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeExtent of recognition.
3-122ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeExtent of recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4-105ANSI/ADA Standard No.75 (Reaffirmed by ANSI: September 8, 2014) Resilient Lining Materials For Removable Dentures, Part 1: Short-Term MaterialsReaffirmation.
4-130ANSI/ADA Standard No. 17 (Reaffirmed by ANSI: September 8, 2014) Denture Base Temporary Relining ResinsReaffirmation.
4-150ANSI/ADA Specification No. 19-2004/ISO 4823:2000 (Reaffirmed by ANSI: October 6, 2014) Dental Elastomeric Impression MaterialsReaffirmation.
4-184ANSI/ASA S3.25-2009 (Revision of ANSI S3.25-1989) (Reaffirmed by ANSI September 11, 2014) American National Standard For an Occluded Ear SimulatorReaffirmation.
4-1914-220ANSI/ASA S3.22-2014 AMERICAN NATIONAL STANDARD Specification of Hearing Aid CharacteristicsWithdrawn and replaced with newer version.
E. General I (Quality Systems/Risk Management (QS/RM))
5-67ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devicesWithdrawn. See 5-96.
5-87IEC 62366 Edition 1.1 2014-01 Medical devices—Application of usability engineering to medical devicesWithdrawn. See 5-95.
5-94AAMI/CN20 (PS):2014 Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methodsWithdrawn. See 5-97.
F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
19-6IEC 60601-1-11 Edition 1.0 2010-04 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)]Transition Period Added.
G. General Hospital/General Plastic Surgery (GH/GPS)
6-110ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander DevicesReaffirmation.
6-185ASTM F881−94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial ImplantsReaffirmation.
6-200ASTM E1061-01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead ThermometersReaffirmation.
6-2746-341ISO 11608-1 Third Edition 2014-12-15 Needle-based injection systems for medical use—Requirements and test methods—Part 1: Needle-based injection systemsWithdrawn and replaced with newer version.
6-301ISO 10555-1 Second Edition 2013-07-01 Sterile, single-use intravascular catheters—Part 1: General requirementsExtent of Recognition.
6-3086-342IEC 80601-2-35 Edition 2.0 2009-10 Medical electrical equipment—Part 2-35: 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)]Withdrawn and replaced with newer version including Technical Corrigendum.
6-3266-343USP 38-NF 33:2015 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-3276-344USP 38-NF 33:2015 Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-3286-345USP 38-NF33:2015 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-3296-346USP 38-NF33:2015 <881> Tensile StrengthWithdrawn and replaced with newer version.
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6-3306-347USP 38-NF33:2015 <861> Sutures—DiameterWithdrawn and replaced with newer version.
6-3316-348USP 38-NF33:2015 <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
6-3326-349USP 38-NF33:2015 Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-3336-350USP 38-NF33:2015 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
6-3346-351USP 38-NF33:2015 Absorbable Surgical SutureWithdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
7-1107-251CLSI EP05-A3 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Third EditionWithdrawn and replaced with newer version.
7-1437-252CLSI EP14-A3 Evaluation of Matrix Effects; Approved Guideline—Third EditionWithdrawn and replaced with newer version.
7-1537-253CLSI EP15-A3 User Verification of Performance for Precision and Estimation of Bias; Approved Guideline-Third EditionWithdrawn and replaced with newer version.
7-2307-254CLSI M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard—Ninth EditionWithdrawn and replaced with newer version.
7-1237-255CLSI MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second EditionWithdrawn and replaced with newer version.
7-2477-256CLSI M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational SupplementWithdrawn and replaced with newer version.
I. Materials
8-598-386ISO 5832-4 Third edition 2014-09-15 Implants for surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloyWithdrawn and replaced newer version.
8-638-387ISO 5832-11 Second edition 2014-09-15 Implants for surgery—Metallic materials—Part 11: Wrought titanium 6-aluminium 7-niobium alloyWithdrawn and replaced with newer version.
8-177ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesUpdated to incorporate transferred recognitions 3-76 and 17-9.
J. Neurology
17-9ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesTransferred. See 8-177.
17-4ASTM F647-94(2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationReaffirmation.
K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology
9-739-104ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapiesWithdrawn and replaced with newer version.
9-97ISO 13958 Third edition 2014-04-01 Concentrates for haemodialysis and related therapiesExtent of recognition.
9-699-105ANSI/AAMI 13959:2014 Water for hemodialysis and related therapiesWithdrawn and replaced with newer version.
9-100ISO 11663 Second edition 2014-04-01 Quality of dialysis fluid for haemodialysis and related therapiesExtent of recognition.
9-719-106ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis and related therapiesWithdrawn and replaced with newer version.
9-709-107ANSI/AAMI 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapiesWithdrawn and replaced with newer version.
9-102ISO 4074 Second edition 2014-08-15 Natural latex rubber condoms—Requirements and test methodsExtent of recognition.
9-909-108ISO 8009 Second edition 2014-11-15 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and testsWithdrawn and replaced with newer version.
9-569-109ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)Withdrawn and replaced with newer version.
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L. Ophthalmic
10-2910-94ISO 14730 Second edition 2014-10-01 Ophthalmic Optics—Contact lens care products—antimicrobial preservative efficacy testing and guidance on determining discard dateWithdrawn and replaced with newer version.
10-5510-95ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants—intraocular lenses—Part 6: Shelf-life and transport stabilityWithdrawn and replaced with newer version.
10-6210-96ANSI Z80.10-2014 American National Standard for Opthalmics Ophthalmic Instruments—TonometersWithdrawn and replaced with newer version.
10-6810-97ISO 13212 Third edition 2014-09-01 Ophthalmic Optics-Contact lens care products—Guidelines for determination of shelf-lifeWithdrawn and replaced with newer version.
10-8210-98ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methodsWithdrawn and replaced with newer version.
M. Orthopedic
11-24011-287ASTM F382-14 Standard Specification and Test Method for Metallic Bone PlatesWithdrawn and replaced newer version.
11-23511-288ASTM F2077-14 Test Methods for Intervertebral Body Fusion DevicesWithdrawn and replaced with newer version.
11-20711-289ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemWithdrawn and replaced with newer version.
11-183ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper InterfaceReaffirmation.
11-266ASTM F2665-09 (Reapproved 2014) Standard Specification for Total Ankle Replacement ProsthesisReaffirmation.
11-224ASTM F2706-08 (Reapproved 2014) Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.Reaffirmation.
11-8011-290ISO 8828 Second edition 2014-11-15 Implants for surgery—Guidance on Care and Handling of Orthopaedic ImplantsWithdrawn and replaced with newer version.
11-24811-291ISO 14242-1 Third edition 2014-10-15 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear testing machines and corresponding environmental conditions for testWithdrawn and replaced with newer version.
11-25011-292ISO 14243-3 Second edition 2014-11-01 Implants for surgery—Wear of total knee prostheses—Part 3: Loading and displacement parameters for wear—testing machines with displacement control and corresponding environmental conditions for testWithdrawn and replaced with newer version.
N. Radiology
12-102ANSI/IESNA RP-27.2-2000 (Reaffirmed 2011) Photobiological Safety for Lamp & Lamp Systems-Measurement TechniquesReaffirmation.
12-21212-289IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment—Characteristics of digital x-ray imaging devices—Part 1-1: Determination of the detective quantum efficiency—Detectors used in radiographic imagingWithdrawn and replaced with newer version.
12-22912-290IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment—Radiation dose documentation—Part 1: Radiation dose structured reports for radiography and radioscopyWithdrawn and replaced with newer version.
12-27812-291IEC 62127-2 Edition 1.1 2013-02 Ultrasonics Hydrophones—Part 2: Calibration for ultrasonic fields up to 40 MHzWithdrawn and replaced with newer version.
O. Sterility
14-19314-457ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging [Including: Amendment 1 (2014)]Withdrawn and replaced with newer version including Amendment.
14-19414-458ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes[Including: Amendment 1 (2014)]Withdrawn and replaced with newer version including Amendment.
14-19514-459ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products—Chemical indicators—Part 1: General requirementsWithdrawn and replaced with newer version.
14-287ANSI/AAMI/ISO 11737-2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processReaffirmation.
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14-29714-461ANSI/AAMI/ISO 11137-1:2006/(R) 2010 Sterilization Of Health Care Products—Radiation—Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices [Including: Amendment 1 (2013)]Withdrawn and replaced with newer version including Amendment.
14-30014-462ASTM D4169—14 Standard Practice for Performance Testing of Shipping Containers and SystemsWithdrawn and replaced with newer version.
14-327ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processExtent of Recognition.
14-350ANSI/AAMI/ISO 13408-4:2005/(R)2014, Aseptic processing of health care products—Part 4: Clean-in-place technologiesReaffirmation.
14-35314-460ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products—Chemical indicators—Part 1: General requirementsWithdrawn and replaced with newer version.
14-39114-463ISO/ASTM 51608 Third edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeVWithdrawn and replaced with newer version.
14-39214-464ISO/ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeVWithdrawn and replaced with newer version.
14-43114-465ISO/ASTM 51707 Third edition 2015-03-15 Guide for estimation of measurement uncertainty in dosimetry for radiation processingWithdrawn and replaced with newer version.
14-44014-466USP 38-NF33:2015 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-44114-467USP 38-NF33:2015 <71> Sterility TestsWithdrawn and replaced with newer version.
14-44214-468USP 38-NF33:2015 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-44314-477USP 38-NF33:2015 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version.
14-44414-469USP 38-NF33:2015 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version.
14-44514-470USP 38-NF33:2015 Biological Indicator for Steam Sterilization—Self ContainedWithdrawn and replaced with newer version.
14-44614-471USP 38-NF33:2015 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-44714-472USP 38-NF33:2015 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-44814-473USP 38-NF33:2015 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-44914-474USP 38-NF33:2015 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
14-45014-475USP 38-NF33:2015 <55> Biological Indicators—Resistance Performance TestsWithdrawn and replaced with newer version.
14-45114-476USP 38-NF33:2015 <1035> Biological Indicators for SterilizationWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 040.

Table 2—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and date
A. Anesthesia
1-104Medical electrical equipment—Part 2-13: Particular Requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)]ISO 80601-2-13 First Edition 2011-08-01 and Amendment 1 2015.
1-105Medical electrical equipment—Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patientsISO 80601-2-72 First Edition 2015-04-11.
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B. Biocompatibility
2-221Biological Evaluation of Medical Devices: Part 2—Animal Welfare RequirementsANSI/AAMI/ISO 10993-2:2006 (R2014).
2-222Biological Evaluation of Medical Devices: Part 2—Animal Welfare RequirementsISO 10993-2 Second edition 2006-07-15.
C. Cardiovascular
3-135Cardiovascular implants and extracorporeal systems—Vascular device-drug combination productsISO/TS 12417-1 First edition 2011-06-01.
3-136Cardiovascular implants and extracorporeal systems—Vascular device-drug combination productsANSI/AAMI/ISO TIR12417:2011.
3-137Standard Guide for Testing Absorbable StentsASTM F3036-13.
3-138Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular StentsASTM F2942-13.
3-139Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devicesISO 14117 First edition 2012-07-15.
D. General I (Quality Systems/Risk Management)
5-95Medical devices—Part 1: Application of usability engineering to medical devicesIEC 62366-1 Edition 1.0 2015-02.
5-96Medical devices—Part 1: Application of usability engineering to medical devicesANSI/AAMI/IEC 62366-1:2015.
5-97Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methodsISO 80369-20 First edition 2015-05-15.
E. General II (ES/EMC)
19-14Medical 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 environmentIEC 60601-1-11 Edition 2.0 2015-01.
19-15Medical electrical equipment—Part 1-12: General requirements 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 environmentIEC 60601-1-12 Edition 1.0 2014-06.
F. GH/GPS
6-352Standard Specification for Implantable Breast ProsthesesASTM F703-07.
6-353Standard Specification for Implantable Saline Filled Breast ProsthesisASTM F2051−00 (Reapproved 2014).
6-354Standard Specification for Radiation Attenuating Protective GlovesASTM D7866-14.
G. IVD
7-257Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved GuidelineCLSI M56-A.
7-258Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standards- Twelfth EditionCLSI M02-A12.
H. Materials
8-388Implants for surgery—Ceramic materials—Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcementISO 6474-2 First edition 2012-04-15.
8-389Implants for surgery—Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devicesISO 15309 First edition 2013-12-01.
8-390Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical ImplantsASTM F1925-09.
8-391Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal To 70% GlycolideASTM F2313-10.
I. Nanotechnology
18-4Technical Specification—Nanotechnologies—Vocabulary—Part 6: Nano-object characterizationISO/TS 80004-6 First edition 2013-11-01.
J. Neurology
17-14Transcutaneous electrical nerve stimulatorsANSI/AAMI NS4:2013.
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K. OB-GYN-GU/Gastroenterology
9-103Water treatment equipment for hemodialysis and related therapiesANSI/AAMI 26722:2014.
L. Ophthalmic
10-99Anionic and non-ionic surface active agents—Determination of critical micellization concentration—Method by measuring surface tension with a plate, stirrup, or ring,ISO 4311 First edition 1979-06-01.
M. Orthopedic
11-293Standard Test Method for Impingement of Acetabular ProsthesesASTM F2582-14.
11-294Standard Specification for Articulating Total Wrist ImplantsASTM F1357-14.
11-295Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip ProsthesisASTM F2580-13.
N. Physical Medicine
16-194Wheelchairs Part 25:Batteries and chargers for powered wheelchairsISO 7176-25 First edition 2013-07-15.
O. Radiology
12-292IEEE Recommended Practice for Three-Dimensional (3D) Medical ModelingIEEE Std 3333.2.1-2015.
P. Software/Informatics
13-73Systematized Nomenclature of Medicine—Clinical TermsIHTSDO SNOME-CT RF2 Release 2015.
13-74Health informatics—Personal health device communication, Part 10424: Device Specialization—Sleep Apnoea Breathing Therapy Equipment (SABTE)IEEE Std 11073-10424-2014.
13-75Health informatics—Point-of-care medical device communication—Part 10102: Nomenclature—Annotated ECGISO/IEEE 11073-10102 First edition 2014-03-01.
13-76Health informatics—Standard communication protocol—Part 91064: Computer-assisted electrocardiographyISO 11073-91064 First edition 2009-05-01.
13-77Information technology—Security techniques—Vulnerability disclosureISO/IEC 29147 First edition 2014-02-15.
13-78Information technology—Security techniques—Vulnerability handling processesISO/IEC 30111 First edition 2013-11-01.
Q. Sterility
14-478Flexible and semi-rigid endoscope processing in health care facilitiesANSI/AAMI ST91:2015.
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 standards@cdrh.fda.gov. 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 Start Printed Page 48879Recognized 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.

Start Signature

Dated: August 10, 2015.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2015-19991 Filed 8-13-15; 8:45 am]

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