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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 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 Start Printed Page 19197comment 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.

Start Further Info

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 (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 Start Printed Page 19198revisions 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
1-921-106ISO 17510 First Edition 2015-08-01 Medical Devices—Sleep Apnoea Breathing Therapy—Masks and Application AccessoriesWithdrawn and replaced with newer version.
1-93ISO 5361 Second Edition 2012-10-01 Anaesthetic and Respiratory Equipment—Tracheal Tubes and ConnectorsExtent of recognition.
B. Biocompatibility
2-180ANSI/AAMI/ISO 10993-16:2010/(R) 2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesReaffirmation.
C. Cardiovascular
3-119ISO 5841-3 Third Edition 2013-04-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [is-i] for implantable pacemakersWithdrawn—Duplicate recognition—See 3-125.
3-138ASTM F2942-13 Standard Guide For the In Vitro Axial, Bending, and Rotational Durability Test of Vascular StentsExtent of recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4-1214-221ISO 7494-2 Second Edition 2015-04-01 Dentistry—Dental units—Part 2: Air, water, suction and wastewater systemWithdrawn and replaced with newer version.
4-1324-222ISO 6874 Third Edition 2015-09-01 Dentistry—Polymer-based pit and fissure sealantsWithdrawn and replaced with newer version.
4-1784-223ISO 6872 Fourth Edition 2015-06-01 Dentistry—Ceramic materialsWithdrawn and replaced with newer version.
4-190ANSI/ASA S3.35-2010 (R2015) Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working ConditionsReaffirmation.
4-194ANSI/ADA Specification No. 78: 2006, Dental Obturating Cones (Modified adoption of ISO 6877-1:1995, Dental Obturating Points)Extent of recognition.
4-202ANSI/ADA Specification No. 58 Root Canal Files, Type H (Hedstrom)Extent of recognition.
4-2094-224ISO 24234 Second Edition 2015-05-01 Dentistry—Dental amalgamWithdrawn and replaced with newer version.
4-2104-225ISO 4823 Fourth Edition 2015-08-01 Dentistry—Elastomeric impression materialsWithdrawn and replaced with newer version.
4-213ISO 7494-1 Second Edition 2011-08-15 Dentistry—Dental units—Part 1: General requirements and test methodsExtent of recognition.
4-214ISO 10139-1 Second Edition 2005-02-15 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: Technical Corrigendum 1 (2006)]Extent of recognition.
E. General I (Quality Systems/Risk Management (QS/RM)
5-435-98ANSI/ESD S20.20-2014 Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices)Withdrawn and replaced with newer version.
5-805-99ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for TestingWithdrawn and replaced with newer version.
F. General II (Electrical Safety/Electromagnetic Compatibility)(ES/EMC)
19-719-16ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD) 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 environmentWithdrawn and replaced with newer version.
19-7AAMI/ANSI HA60601-1-11:2011, 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)Transition period.
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G. General Hospital/General Plastic Surgery (GH/GPS)
6-1696-355ASTM D3772—15 Standard Specification for Industrial Rubber Finger CotsWithdrawn and replaced with newer version.
6-2436-356ASTM D5712—15 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry MethodWithdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
7-1677-259CLSI GP23-A Nongynecologic Cytologic Specimens: Collection And Cytopreparatory Techniques; Approved GuidelineWithdrawn and replaced with newer version.
7-1327-260CLSI MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved GuidelineWithdrawn and replaced with newer version.
7-229CLSI M02-A11 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh EditionWithdrawn. See 7-258.
I. Materials
8-103ASTM F1807-97 (Reapproved 2014) Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsReaffirmation.
8-107ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsReaffirmation.
8-114ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension LoadingReaffirmation.
8-115ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingReaffirmation.
8-116ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in TensionReaffirmation.
8-121ASTM F2005-05 (Reapproved 2015) Standard Terminology for Nickel-Titanium Shape Memory AlloysReaffirmation.
8-1348-392ASTM F2082-15 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free RecoveryWithdrawn and replaced with newer version.
8-135ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical SealantsReaffirmation.
8-136ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsReaffirmation.
8-1678-393ASTM F1350-15 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)Withdrawn and replaced with newer version.
8-1688-394ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)Withdrawn and replaced with newer version.
8-1708-395ASTM F961-14 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version.
8-1778-396ASTM F2129-15 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version.
8-179ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding PowdersReaffirmation.
8-1848-397ASTM F2516-14 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic MaterialsWithdrawn and replaced with newer version.
8-1898-398ASTM F1108-14 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)Withdrawn and replaced with newer version.
8-1908-399ASTM F90-14 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)Withdrawn and replaced with newer version.
8-1928-400ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsWithdrawn and replaced with newer version.
8-200ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirReaffirmation.
8-2048-401ASTM F2118-14 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsWithdrawn and replaced with newer version.
Start Printed Page 19200
8-2068-402ASTM F688-14 Standard Specification for Wrought Cobalt-35Nickel-20Chromium 10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version.
8-225ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirWithdrawn. See 8-200.
8-3638-403ASTM D638-14 Standard Test Method for Tensile Properties of PlasticsWithdrawn and replaced with newer version.
8-3678-404ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth RatesWithdrawn and replaced with newer version.
8-369ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirWithdrawn. See 8-200.
8-3868-405ISO 5832-4 Third Edition 2014-09-15 Implants for surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloyWithdrawn and replaced with newer version.
8-3878-406ISO 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.
J. Nanotechnology
18-1ASTM E2490-09 (Reapproved 2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)Reaffirmation.
K. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
9-61IEC 60601-2-18 Edition 3.0 2009-08 Medical Electrical Equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmentWithdrawn. Merged with 4-187.
9-839-110ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirementsWithdrawn and replaced with newer version.
9-96CEN EN 1618:1997 Catheters Other Than Intravascular Catheters—Test Methods for Common PropertiesDuplicate recognition number. See 9-113.
9-1029-111ISO 4074 Third Edition 2015-10-15 Natural rubber latex male condoms—Requirements and test methodsWithdrawn and replaced with newer version.
9-1099-112ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms)Withdrawn and replaced with newer version.
L. Ophthalmic
10-73ANSI Z80.21-2010 (R2015) Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity ChartsReaffirmation.
M. Orthopedic
11-20711-296ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal SystemWithdrawn and replaced with newer version.
11-21411-297ASTM F382—14 Standard Specification and Test Method for Metallic Bone PlatesWithdrawn and replaced with newer version.
11-21611-298ASTM F1264—14 Standard Specification and Test Methods for Intramedullary Fixation DevicesWithdrawn and replaced with newer version.
11-22011-299ASTM F2068—15 Standard Specification for Femoral Prostheses—Metallic ImplantsWithdrawn and replaced with newer version.
11-227ASTM F366-10 (Reapproved 2015) Standard Specification for Fixation Pins and WiresReaffirmation.
11-228ASTM F564-10 (Reapproved 2015) Standard Specification and Test Methods for Metallic Bone StaplesReaffirmation.
11-247ASTM F2789-10 (Reapproved 2015) Standard Guide for Mechanical and Functional Characterization of Nucleus DevicesReaffirmation.
11-256ISO 14243-3 First Edition 2004-09-25 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)]Withdrawn. See 11-292.
11-26211-301ASTM F2091-15 Standard Specification for Acetabular ProsthesesWithdrawn and replaced with newer version.
Start Printed Page 19201
11-27811-302ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version.
N. Physical Medicine
16-15816-195ISO 7176-1 Third Edition 2014-10-01 Wheelchairs—Part 1: Determination of static stabilityWithdrawn and replaced with newer version.
O. Radiology
12-139NEMA UD 2-2004 (R2009) Acoustic output measurement standard for diagnostic ultrasound equipment, Revision 3Reaffirmation.
12-187NEMA MS 3-2008 (R2014) Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesReaffirmation.
12-188NEMA MS 1-2008 (R2014) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagingReaffirmation.
12-195NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)Reaffirmation.
12-196NEMA MS 2-2008 (R2014) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance ImagesReaffirmation.
12-207IEC 60601-2-33 Ed. 3.0 2010 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisExtent of recognition.
12-20912-293IEC 60601-2-37 Ed. 2.1 b:2015 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipmentWithdrawn and replaced with newer version.
12-23612-294IEC 60601-2-45 Ed. 3.1 b:2015 Medical electrical equipment—Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devicesWithdrawn and replaced with newer version.
12-25712-297ISO 2919 Third Edition 2012-02-15 Radiation protection—Sealed radioactive sources—General requirements and classificationDuplicate recognition number. See 12-297.
12-27112-295IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosisWithdrawn and replaced with newer version.
12-27412-296IEC 60601-2-54 Ed. 1.1 b:2015 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyWithdrawn and replaced with newer version.
12-288NEMA MS 9-2008 (R2014) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)Reaffirmation.
P. Software/Informatics
13-813-79IEC 62304 Edition 1.1 2015-06 Medical device software—Software life cycle processesWithdrawn and replaced with newer version.
13-5013-80IEEE Std. 11073-20601: 2014 Health informatics—Personal health device communication—Part 20601: Application profile—Optimized Exchange Protocol [including: Corrigendum 1 (2015)]Withdrawn and replaced with newer version.
13-51IEEE Std. 11073-20601a-2010 Health informatics—Personal health device communication—Part 20601: Application profile—Optimized Exchange Protocol Amendment 1Withdrawn. See 13-80.
Q. Sterility
14-227ANSI/AAMI/ISO 11737-1:2006 (R)2011 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on productExtent of recognition.
14-261ANSI/AAMI/ISO 17665-1:2006/(R)2013 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-277ISO/TS 17665-2 First Edition 2009-01-15 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665-1Extent of recognition.
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 processExtent of recognition.
Start Printed Page 19202
14-291ANSI/AAMI/ISO 14937:2009/(R)2013 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 devicesExtent of recognition.
14-296ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirementsExtent of recognition.
14-298ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspectsExtent of recognition.
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.
14-330ISO 11137-3 First Edition 2006-04-15 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspectsExtent of recognition.
14-333ISO 17665-1 First Edition 2006-08-15 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-337ISO 14937 Second Edition 2009-10-15 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 devicesExtent of recognition.
14-338ISO 11138-1 Second Edition 2006-07-01 Sterilization of health care products—Biological indicators—Part 1: General requirementsExtent of recognition.
14-339ANSI/AAMI/ISO 20857:2010 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-340ISO 20857 First Edition 2010-08-15 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-349ANSI/AAMI/ISO 13408-3:2006/(R)2015 Aseptic processing of health care products—Part 3: LyophilizationReaffirmation.
14-351ANSI/AAMI/ISO 13408-5:2006/(R)2015 Aseptic processing of health care products—Part 5: Sterilization in placeReaffirmation.
14-376ANSI/AAMI/ISO TIR17665-2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1Extent of recognition.
14-407ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]Extent of recognition.
14-409ISO 11137-2 Third Edition 2013-06-01 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseExtent of recognition.
14-428ISO 11137-1 First Edition 2006-04-15 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)]Extent of recognition.
14-438ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseExtent of recognition.
14-452ISO 11135 Second Edition 2014, Sterilization of health care products—Ethylene oxide—Requirements for development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-461ANSI/AAMI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]Extent of recognition.
R. Tissue Engineering
15-815-42ASTM F2064-14 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product ApplicationsWithdrawn and replaced with newer version.
15-2215-43ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two DimensionsWithdrawn and replaced with newer version.
15-24ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone DefectsReaffirmation.
1 All standard titles in this table conform to the style requirements of the respective organizations.
Start Printed 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 1Reference No. and date
A. Anesthesia
1-107Anaesthetic and Respiratory Equipment—Conical Connectors—Part 1: Cones and SocketsANSI/AAMI/ISO 5356-1:2004.
1-108Anaesthetic and Respiratory Equipment—Tracheal Tubes and ConnectorsANSI/AAMI/ISO 5361:2012.
1-109Anaesthetic Reservoir BagsANSI/AAMI/ISO 5362:2006.
1-110Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in AdultsANSI/AAMI/ISO 5366-1:2000.
1-111Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy TubesANSI/AAMI/ISO 5366-3:2001.
1-112Lung Ventilators—Part 4: Particular Requirements for Operator-Powered ResuscitatorsANSI/AAMI/ISO 10651-4:2002.
1-113Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency ResuscitatorsANSI/AAMI/ISO 10651-5:2006.
1-114Inhalational Anaesthesia Systems—Draw-over Anaesthetic SystemsISO 18835 First Edition 2015-04-01.
1-115Medical Electrical Equipment—Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy EquipmentISO 80601-2-70 First Edition 2015-01-15.
B. Biocompatibility
2-223Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical DevicesASTM F2901-13.
2-225Standard Practice for Testing for Classical Complement Activation in Serum By Solid MaterialsASTM F2567-06 (Reapproved 2010).
C. Cardiovascular
3-140Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniquesANSI/AAMI/ISO 5840-3: 2013.
3-141Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakersANSI/AAMI/ISO 5841-3: 2013.
D. Dental/ENT
4-226Dentistry—Powered polymerization activatorsISO 10650 First Edition 2015-09-01.
E. General I (Quality Systems/Risk Management)
5-100Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methodsANSI/AAMI/ISO 80369-20:2015.
5-101Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applicationsAAMI/CN6:2015.
F. General II (ES/EMC)
19-17American National Standard 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 TransmittersANSI/IEEE C63.18-2014.
19-18Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements [Including: Corrigendum 1 (2011)]IEC 61010-1 Edition 3.0 2010-06.
Start Printed Page 19204
G. GH/GPS
6-357Intravascular Catheters—Sterile and Single-use Catheters—Part 6: Subcutaneous Implanted PortsISO 10555-6 First Edition 2015-04-15.
6-358Infusion Equipment for Medical Use—Part 8: Infusion Sets for Single Use with Pressure Infusion ApparatusISO 8536-8 Second Edition 2015-06-15.
6-359Infusion Equipment for Medical Use—Part 9: Fluid Lines for Single Use with Pressure Infusion EquipmentISO 8536-9 Second Edition 2015-06-15.
6-360Infusion Equipment for Medical Use—Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion EquipmentISO 8536-10 Second Edition 2015-06-15.
6-361Infusion Equipment for Medical Use—Part 11: Infusion Filters for Single Use with Pressure Infusion EquipmentISO 8536-11 Second Edition 2015-06-15.
H. Materials
8-407Standard Specification for Additive Manufacturing File Format (AMF) Version 1.1ISO/ASTM 52915 First Edition 2013-06-01.
8-408Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing ProcessesASTM F3122-14.
8-409Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed FusionASTM F2924-14.
8-410Standard Guide for Assessment of Absorbable Polymeric ImplantsASTM F2902-12.
8-411Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical ImplantsASTM F2579-10.
8-412Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure MicromotionASTM F2537-06 (Reapproved 2011).
8-413Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing, and Wire to be used for Medical DevicesASTM F2819-10 (Reapproved 2015).
8-414Standard Practice for Reporting and Assessment of Residues on Single Use ImplantsASTM F2847-10.
8-415Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR).ASTM F2778-09 (Reapproved 2015).
8-416Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical ImplantsASTM F2977-13.
8-417Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical ImplantsASTM F3044-14.
8-418Standard Test Methods for Determining Radiopacity for Medical UseASTM F640-12.
8-419Standard Specification for Metal Injection Molded Titanium-6 Aluminum-4 Vanadium Components for Surgical Implant ApplicationsASTM F2885-11.
8-420Standard Specification for Metal Injection Molded Cobalt-28 Chromium-6 Molybdenum Components for Surgical Implant ApplicationsASTM F2886-10.
I. Ophthalmic
10-100Ophthalmic optics—Contact lens care products—Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organismsISO 18259 First Edition 2014-10-01.
J. Orthopedic
11-303Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard ArticulationsASTM F3047M-15.
Start Printed Page 19205
11-304Measuring Accuracy after Mechanical DisturbancesASTM F3107-14.
K. Physical Medicine
16-196Wheelchairs—Part 7: Measurement of seating and wheel dimensionsISO 7176-7 First Edition 1998-05-15.
16-197Wheelchairs—Part 8: Requirements and test methods for static, impact, and fatigue strengthsISO 7176-8 Second Edition 2014-12-15.
16-198Wheelchairs—Part 22: Set-up proceduresISO 7176-22 Second Edition 2014-09-01.
L. Software/Informatics
13-81Health informatics—Personal health device communication—Part 10419: Device Specialization—Insulin PumpIEEE Std. 11073-10419: 2015.
M. Sterility
14-479Sterilization of health care products—Ethylene oxide—Requirements for development, validation, and routine control of a sterilization process for medical devicesANSI/AAMI/ISO 11135:2014.
N. Tissue Engineering
15-44Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) Active StandardASTM F2529-13.
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 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.

Start Signature

Dated: March 29, 2016.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2016-07467 Filed 4-1-16; 8:45 am]

BILLING CODE 4164-01-P