[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48871-48879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19991]
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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.
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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.
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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.
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[[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.
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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)].
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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.
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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.
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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.
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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.
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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).
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[[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.
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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.
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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.
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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