80 FR 48871 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range		48871-48879
FR Document		2015-19991

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.

Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015)

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48871-48879]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-19991]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451; formerly Docket No. 2004N-0226]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 040'' (Recognition List Number: 040), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document
at any time. See section VII for the effective date of the recognition
of standards announced in this document.

ADDRESSES: An electronic copy of Recognition List Number: 040 is
available on the Internet at http://

[[Page 48872]]

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/
ucm123792.htm. See section VI for electronic access to the searchable
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 040 modifications and other
standards related information.
Submit written requests for a single hard copy of the document
entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 040'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section
514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains HTML and PDF
versions of the list of FDA Recognized Consensus Standards. Both
versions are publicly accessible at the Agency's Internet site. See
section VI for electronic access information. Interested persons should
review the supplementary information sheet for the standard to
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 040

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 040'' to identify these current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-46............................. 1-103 ISO 5367 Fifth edition 2014-10- Withdrawn and replaced with
15 Anaesthetic and respiratory newer version.
equipment--Breathing sets and
connectors.
1-82............................. .............. IEC 60601-2-13 Edition 3.1 2009- Withdrawn. See 1-104.
08, Medical electrical
equipment--Part 2-13:
Particular requirements for the
safety and essential
performance of anaesthetic
systems.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-179............................ 2-220 ISO 10993-1 Fourth edition 2009- Withdrawn and replaced with
10-15 Biological evaluation of newer version including
medical devices--Part 1:. Technical Corrigendum.
Evaluation and Testing within a
risk management process
[Including: Technical
Corrigendum 1 (2010)].
2-208............................ 2-215 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Direct Contact Test.
2-209............................ 2-216 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Elution Test.
2-210............................ 2-217 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo, newer version.
Procedure Preparation of Sample.
2-211............................ 2-218 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Test, In Vitro, newer version.
Classification of Plastics--
Intracutaneous Test.
2-212............................ 2-219 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo, newer version.
Classification of Plastics--
Systemic Injection Test.
----------------------------------------------------------------------------------------------------------------

[[Page 48873]]

C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-76............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177.
Method for Conducting Cyclic
Potentiodynamic Polarization
Measurements to Determine The
Corrosion Susceptibility of
Small Implant Devices.
3-117............................ .............. ANSI/AAMI/ISO 81060-2:2013 Non- Extent of recognition.
invasive sphygmomanometers--
Part 2: Clinical validation of
automated measurement type.
3-122............................ .............. ISO 81060-2 Second edition 2013- Extent of recognition.
05-01 Non-invasive
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105............................ .............. ANSI/ADA Standard No.75 Reaffirmation.
(Reaffirmed by ANSI: September
8, 2014) Resilient Lining
Materials For Removable
Dentures, Part 1: Short-Term
Materials.
4-130............................ .............. ANSI/ADA Standard No. 17 Reaffirmation.
(Reaffirmed by ANSI: September
8, 2014) Denture Base Temporary
Relining Resins.
4-150............................ .............. ANSI/ADA Specification No. 19- Reaffirmation.
2004/ISO 4823:2000 (Reaffirmed
by ANSI: October 6, 2014)
Dental Elastomeric Impression
Materials.
4-184............................ .............. ANSI/ASA S3.25-2009 (Revision of Reaffirmation.
ANSI S3.25-1989) (Reaffirmed by
ANSI September 11, 2014)
American National Standard For
an Occluded Ear Simulator.
4-191............................ 4-220 ANSI/ASA S3.22-2014 AMERICAN Withdrawn and replaced with
NATIONAL STANDARD Specification newer version.
of Hearing Aid Characteristics.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-67............................. .............. ANSI/AAMI/IEC 62366:2007/(R)2013 Withdrawn. See 5-96.
Medical devices--Application of
usability engineering to
medical devices.
5-87............................. .............. IEC 62366 Edition 1.1 2014-01 Withdrawn. See 5-95.
Medical devices--Application of
usability engineering to
medical devices.
5-94............................. .............. AAMI/CN20 (PS):2014 Small-bore Withdrawn. See 5-97.
connectors for liquids and
gases in healthcare
applications--Part 20: Common
test methods.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
----------------------------------------------------------------------------------------------------------------
19-6............................. .............. IEC 60601-1-11 Edition 1.0 2010- Transition Period Added.
04 Medical Electrical
Equipment--Part 1-11: General
Requirements for Basic Safety
and Essential Performance--
Collateral Standard:
Requirements for Medical
Electrical Equipment and
Medical Electrical Systems used
in the Home Healthcare
Environment [Including:
Technical Corrigendum 1 (2011)].
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-110............................ .............. ASTM F1441-03 (Reapproved 2014) Reaffirmation.
Standard Specification for Soft-
Tissue Expander Devices.
6-185............................ .............. ASTM F881-94 (Reapproved 2014) Reaffirmation.
Standard Specification for
Silicone Elastomer Facial
Implants.
6-200............................ .............. ASTM E1061-01 (Reapproved 2014) Reaffirmation.
Standard Specification for
Direct-Reading Liquid Crystal
Forehead Thermometers.
6-274............................ 6-341 ISO 11608-1 Third Edition 2014- Withdrawn and replaced with
12-15 Needle-based injection newer version.
systems for medical use--
Requirements and test methods--
Part 1: Needle-based injection
systems.
6-301............................ .............. ISO 10555-1 Second Edition 2013- Extent of Recognition.
07-01 Sterile, single-use
intravascular catheters--Part
1: General requirements.
6-308............................ 6-342 IEC 80601-2-35 Edition 2.0 2009- Withdrawn and replaced with
10 Medical electrical newer version including
equipment--Part 2-35: Technical Corrigendum.
Particular requirements for the
basic safety and essential
performance of heating devices
using blankets, pads or
mattresses and intended for
heating in medical use
[Including: Technical
Corrigendum 1 (2012) and
Technical Corrigendum 2 (2015)].
6-326............................ 6-343 USP 38-NF 33:2015 Sodium Withdrawn and replaced with
Chloride Irrigation. newer version.
6-327............................ 6-344 USP 38-NF 33:2015 Sodium Withdrawn and replaced with
Chloride Injection. newer version.
6-328............................ 6-345 USP 38-NF33:2015 Nonabsorbable Withdrawn and replaced with
Surgical Suture. newer version.
6-329............................ 6-346 USP 38-NF33:2015 <881> Tensile Withdrawn and replaced with
Strength. newer version.

[[Page 48874]]

6-330............................ 6-347 USP 38-NF33:2015 <861> Sutures-- Withdrawn and replaced with
Diameter. newer version.
6-331............................ 6-348 USP 38-NF33:2015 <871> Sutures-- Withdrawn and replaced with
Needle Attachment. newer version.
6-332............................ 6-349 USP 38-NF33:2015 Sterile Water Withdrawn and replaced with
for Irrigation. newer version.
6-333............................ 6-350 USP 38-NF33:2015 Heparin Lock Withdrawn and replaced with
Flush Solution. newer version.
6-334............................ 6-351 USP 38-NF33:2015 Absorbable Withdrawn and replaced with
Surgical Suture. newer version.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-110............................ 7-251 CLSI EP05-A3 Evaluation of Withdrawn and replaced with
Precision Performance of newer version.
Quantitative Measurement
Methods; Approved Guideline-
Third Edition.
7-143............................ 7-252 CLSI EP14-A3 Evaluation of Withdrawn and replaced with
Matrix Effects; Approved newer version.
Guideline--Third Edition.
7-153............................ 7-253 CLSI EP15-A3 User Verification Withdrawn and replaced with
of Performance for Precision newer version.
and Estimation of Bias;
Approved Guideline-Third
Edition.
7-230............................ 7-254 CLSI M07-A10 Methods for Withdrawn and replaced with
Dilution Antimicrobial newer version.
Susceptibility Tests for
Bacteria that Grow Aerobically;
Approved Standard--Ninth
Edition.
7-123............................ 7-255 CLSI MM09-A2 Nucleic Acid Withdrawn and replaced with
Sequencing Methods in newer version.
Diagnostic Laboratory Medicine;
Approved Guideline--Second
Edition.
7-247............................ 7-256 CLSI M100-S25 Performance Withdrawn and replaced with
Standards for Antimicrobial newer version.
Susceptibility Testing; Twenty-
Fifth Informational Supplement.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-59............................. 8-386 ISO 5832-4 Third edition 2014-09- Withdrawn and replaced
15 Implants for surgery-- newer version.
Metallic materials--Part 4:
Cobalt-chromium-molybdenum
casting alloy.
8-63............................. 8-387 ISO 5832-11 Second edition 2014- Withdrawn and replaced with
09-15 Implants for surgery-- newer version.
Metallic materials--Part 11:
Wrought titanium 6-aluminium 7-
niobium alloy.
8-177............................ .............. ASTM F2129-08 Standard Test Updated to incorporate
Method for Conducting Cyclic transferred recognitions 3-
Potentiodynamic Polarization 76 and 17-9.
Measurements to Determine the
Corrosion Susceptibility of
Small Implant Devices.
----------------------------------------------------------------------------------------------------------------
J. Neurology
----------------------------------------------------------------------------------------------------------------
17-9............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177.
Method for Conducting Cyclic
Potentiodynamic Polarization
Measurements to Determine the
Corrosion Susceptibility of
Small Implant Devices.
17-4............................. .............. ASTM F647-94(2014) Standard Reaffirmation.
Practice for Evaluating and
Specifying Implantable Shunt
Assemblies for Neurosurgical
Application.
----------------------------------------------------------------------------------------------------------------
K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-73............................. 9-104 ANSI/AAMI/ISO 13958:2014 Withdrawn and replaced with
Concentrates for hemodialysis newer version.
and related therapies.
9-97............................. .............. ISO 13958 Third edition 2014-04- Extent of recognition.
01 Concentrates for
haemodialysis and related
therapies.
9-69............................. 9-105 ANSI/AAMI 13959:2014 Water for Withdrawn and replaced with
hemodialysis and related newer version.
therapies.
9-100............................ .............. ISO 11663 Second edition 2014-04- Extent of recognition.
01 Quality of dialysis fluid
for haemodialysis and related
therapies.
9-71............................. 9-106 ANSI/AAMI/ISO 11663:2014 Quality Withdrawn and replaced with
of dialysis fluid for newer version.
hemodialysis and related
therapies.
9-70............................. 9-107 ANSI/AAMI 23500:2014 Guidance Withdrawn and replaced with
for the preparation and quality newer version.
management of fluids for
hemodialysis and related
therapies.
9-102............................ .............. ISO 4074 Second edition 2014-08- Extent of recognition.
15 Natural latex rubber
condoms--Requirements and test
methods.
9-90............................. 9-108 ISO 8009 Second edition 2014-11- Withdrawn and replaced with
15 Mechanical contraceptives-- newer version.
Reusable natural and silicone
rubber contraceptive
diaphragms--Requirements and
tests.
9-56............................. 9-109 ASTM D3492-08 Standard Withdrawn and replaced with
Specification for Rubber newer version.
Contraceptives (Male Condoms).
----------------------------------------------------------------------------------------------------------------

[[Page 48875]]

L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-29............................ 10-94 ISO 14730 Second edition 2014-10- Withdrawn and replaced with
01 Ophthalmic Optics--Contact newer version.
lens care products--
antimicrobial preservative
efficacy testing and guidance
on determining discard date.
10-55............................ 10-95 ISO 11979-6 Third edition 2014- Withdrawn and replaced with
10-01 Ophthalmic implants-- newer version.
intraocular lenses--Part 6:
Shelf-life and transport
stability.
10-62............................ 10-96 ANSI Z80.10-2014 American Withdrawn and replaced with
National Standard for newer version.
Opthalmics Ophthalmic
Instruments--Tonometers.
10-68............................ 10-97 ISO 13212 Third edition 2014-09- Withdrawn and replaced with
01 Ophthalmic Optics-Contact newer version.
lens care products--Guidelines
for determination of shelf-life.
10-82............................ 10-98 ISO 11979-2 Second edition 2014- Withdrawn and replaced with
08-15 Ophthalmic implants-- newer version.
Intraocular lenses--Part 2:
Optical properties and test
methods.
----------------------------------------------------------------------------------------------------------------
M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-240........................... 11-287 ASTM F382-14 Standard Withdrawn and replaced
Specification and Test Method newer version.
for Metallic Bone Plates.
11-235........................... 11-288 ASTM F2077-14 Test Methods for Withdrawn and replaced with
Intervertebral Body Fusion newer version.
Devices.
11-207........................... 11-289 ASTM F2193-14 Standard Withdrawn and replaced with
Specifications and Test Methods newer version.
for Components Used in the
Surgical Fixation of the Spinal
Skeletal System.
11-183........................... .............. ASTM F1875-98 (Reapproved 2014) Reaffirmation.
Standard Practice for Fretting
Corrosion Testing of Modular
Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper
Interface.
11-266........................... .............. ASTM F2665-09 (Reapproved 2014) Reaffirmation.
Standard Specification for
Total Ankle Replacement
Prosthesis.
11-224........................... .............. ASTM F2706-08 (Reapproved 2014) Reaffirmation.
Standard Test Methods for
Occipital-Cervical and
Occipital-Cervical-Thoracic
Spinal Implant Constructs in a
Vertebrectomy Model..
11-80............................ 11-290 ISO 8828 Second edition 2014-11- Withdrawn and replaced with
15 Implants for surgery-- newer version.
Guidance on Care and Handling
of Orthopaedic Implants.
11-248........................... 11-291 ISO 14242-1 Third edition 2014- Withdrawn and replaced with
10-15 Implants for surgery-- newer version.
Wear of total hip-joint
prostheses--Part 1: Loading and
displacement parameters for
wear testing machines and
corresponding environmental
conditions for test.
11-250........................... 11-292 ISO 14243-3 Second edition 2014- Withdrawn and replaced with
11-01 Implants for surgery-- newer version.
Wear of total knee prostheses--
Part 3: Loading and
displacement parameters for
wear--testing machines with
displacement control and
corresponding environmental
conditions for test.
----------------------------------------------------------------------------------------------------------------
N. Radiology
----------------------------------------------------------------------------------------------------------------
12-102........................... .............. ANSI/IESNA RP-27.2-2000 Reaffirmation.
(Reaffirmed 2011)
Photobiological Safety for Lamp
& Lamp Systems-Measurement
Techniques.
12-212........................... 12-289 IEC 62220-1-1 Edition 1.0 2015- Withdrawn and replaced with
03 Medical electrical newer version.
equipment--Characteristics of
digital x-ray imaging devices--
Part 1-1: Determination of the
detective quantum efficiency--
Detectors used in radiographic
imaging.
12-229........................... 12-290 IEC 61910-1 Edition 1.0 2014-09 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Radiation dose documentation--
Part 1: Radiation dose
structured reports for
radiography and radioscopy.
12-278........................... 12-291 IEC 62127-2 Edition 1.1 2013-02 Withdrawn and replaced with
Ultrasonics Hydrophones--Part newer version.
2: Calibration for ultrasonic
fields up to 40 MHz.
----------------------------------------------------------------------------------------------------------------
O. Sterility
----------------------------------------------------------------------------------------------------------------
14-193........................... 14-457 ANSI/AAMI/ISO 11607-1:2006/ Withdrawn and replaced with
(R)2010 Packaging for newer version including
terminally sterilized medical Amendment.
devices--Part 1: Requirements
for materials, sterile barrier
systems and packaging
[Including: Amendment 1 (2014)].
14-194........................... 14-458 ANSI/AAMI/ISO 11607-2:2006/ Withdrawn and replaced with
(R)2010 Packaging for newer version including
terminally sterilized medical Amendment.
devices--Part 2: Validation
requirements for forming,
sealing and assembly
processes[Including: Amendment
1 (2014)].
14-195........................... 14-459 ANSI/AAMI/ISO 11140-1:2014 Withdrawn and replaced with
Sterilization of health care newer version.
products--Chemical indicators--
Part 1: General requirements.
14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Reaffirmation.
(R)2014 Sterilization of
medical devices--
Microbiological methods--Part
2: Tests of sterility performed
in the definition, validation
and maintenance of a
sterilization process.

[[Page 48876]]

14-297........................... 14-461 ANSI/AAMI/ISO 11137-1:2006/(R) Withdrawn and replaced with
2010 Sterilization Of Health newer version including
Care Products--Radiation--Part Amendment.
1: Requirements For
Development, Validation, And
Routine Control Of A
Sterilization Process For
Medical Devices [Including:
Amendment 1 (2013)].
14-300........................... 14-462 ASTM D4169--14 Standard Practice Withdrawn and replaced with
for Performance Testing of newer version.
Shipping Containers and Systems.
14-327........................... .............. ISO 11737-2 Second edition 2009- Extent of Recognition.
11-15 Sterilization of medical
devices--Microbiological
methods--Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a sterilization
process.
14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Reaffirmation.
(R)2014, Aseptic processing of
health care products--Part 4:
Clean-in-place technologies.
14-353........................... 14-460 ISO 11140-1 Third edition 2014- Withdrawn and replaced with
11-01 Sterilization of health newer version.
care products--Chemical
indicators--Part 1: General
requirements.
14-391........................... 14-463 ISO/ASTM 51608 Third edition Withdrawn and replaced with
2015-03-15 Practice for newer version.
dosimetry in an X-ray
(bremsstrahlung) facility for
radiation processing at
energies between 50 KeV and 7.5
MeV.
14-392........................... 14-464 ISO/ASTM 51649 Third edition Withdrawn and replaced with
2015-03-15 Practice for newer version.
dosimetry in an electron beam
facility for radiation
processing at energies between
300 keV and 25 MeV.
14-431........................... 14-465 ISO/ASTM 51707 Third edition Withdrawn and replaced with
2015-03-15 Guide for estimation newer version.
of measurement uncertainty in
dosimetry for radiation
processing.
14-440........................... 14-466 USP 38-NF33:2015 <61> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Microbial
Enumeration Tests.
14-441........................... 14-467 USP 38-NF33:2015 <71> Sterility Withdrawn and replaced with
Tests. newer version.
14-442........................... 14-468 USP 38-NF33:2015 <85> Bacterial Withdrawn and replaced with
Endotoxins Test. newer version.
14-443........................... 14-477 USP 38-NF33:2015 <151> Pyrogen Withdrawn and replaced with
Test (USP Rabbit Test). newer version.
14-444........................... 14-469 USP 38-NF33:2015 <161> Withdrawn and replaced with
Transfusion and Infusion newer version.
Assemblies and Similar Medical
Devices.
14-445........................... 14-470 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization--Self Contained.
14-446........................... 14-471 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Dry-Heat newer version.
Sterilization, Paper Carrier.
14-447........................... 14-472 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Ethylene Oxide newer version.
Sterilization, Paper Carrier.
14-448........................... 14-473 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization, Paper Carrier.
14-449........................... 14-474 USP 38-NF33:2015 <62> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Tests for
Specified Microorganisms.
14-450........................... 14-475 USP 38-NF33:2015 <55> Biological Withdrawn and replaced with
Indicators--Resistance newer version.
Performance Tests.
14-451........................... 14-476 USP 38-NF33:2015 <1035> Withdrawn and replaced with
Biological Indicators for newer version.
Sterilization.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

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

Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-104.................... Medical electrical ISO 80601-2-13
equipment--Part 2-13: First Edition 2011-
Particular Requirements 08-01 and
for basic safety and Amendment 1 2015.
essential performance
of an anaesthetic
workstation [Including:
Amendment 1 (2015)].
1-105.................... Medical electrical ISO 80601-2-72
equipment--Part 2-72: First Edition 2015-
Particular requirements 04-11.
for basic safety and
essential performance
of home healthcare
environment ventilators
for ventilator-
dependent patients.
------------------------------------------------------------------------

[[Page 48877]]

B. Biocompatibility
------------------------------------------------------------------------
2-221.................... Biological Evaluation of ANSI/AAMI/ISO 10993-
Medical Devices: Part 2:2006 (R2014).
2--Animal Welfare
Requirements.
2-222.................... Biological Evaluation of ISO 10993-2 Second
Medical Devices: Part edition 2006-07-
2--Animal Welfare 15.
Requirements.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-135.................... Cardiovascular implants ISO/TS 12417-1
and extracorporeal First edition 2011-
systems--Vascular 06-01.
device-drug combination
products.
3-136.................... Cardiovascular implants ANSI/AAMI/ISO
and extracorporeal TIR12417:2011.
systems--Vascular
device-drug combination
products.
3-137.................... Standard Guide for ASTM F3036-13.
Testing Absorbable
Stents.
3-138.................... Standard Guide for in ASTM F2942-13.
vitro Axial, Bending,
and Torsional
Durability Testing of
Vascular Stents.
3-139.................... Active implantable ISO 14117 First
medical devices-- edition 2012-07-
Electromagnetic 15.
compatibility--EMC test
protocols for
implantable cardiac
pacemakers, implantable
cardioverter
defibrillators and
cardiac
resynchronization
devices.
------------------------------------------------------------------------
D. General I (Quality Systems/Risk Management)
------------------------------------------------------------------------
5-95..................... Medical devices--Part 1: IEC 62366-1 Edition
Application of 1.0 2015-02.
usability engineering
to medical devices.
5-96..................... Medical devices--Part 1: ANSI/AAMI/IEC 62366-
Application of 1:2015.
usability engineering
to medical devices.
5-97..................... Small-bore connectors ISO 80369-20 First
for liquids and gases edition 2015-05-
in healthcare 15.
applications--Part 20:
Common test methods.
------------------------------------------------------------------------
E. General II (ES/EMC)
------------------------------------------------------------------------
19-14.................... Medical electrical IEC 60601-1-11
equipment--Part 1-11: Edition 2.0 2015-
General requirements 01.
for basic safety and
essential performance--
Collateral Standard:
Requirements for
medical electrical
equipment and medical
electrical systems used
in the home healthcare
environment.
19-15.................... Medical electrical IEC 60601-1-12
equipment--Part 1-12: Edition 1.0 2014-
General requirements 06.
for basic safety and
essential performance--
Collateral Standard:
Requirements for
medical electrical
equipment and medical
electrical systems
intended for use in the
emergency medical
services environment.
------------------------------------------------------------------------
F. GH/GPS
------------------------------------------------------------------------
6-352.................... Standard Specification ASTM F703-07.
for Implantable Breast
Prostheses.
6-353.................... Standard Specification ASTM F2051-00
for Implantable Saline (Reapproved 2014).
Filled Breast
Prosthesis.
6-354.................... Standard Specification ASTM D7866-14.
for Radiation
Attenuating Protective
Gloves.
------------------------------------------------------------------------
G. IVD
------------------------------------------------------------------------
7-257.................... Principles and CLSI M56-A.
procedures for
Detection of Anaerobes
in Clinical Specimens;
Approved Guideline.
7-258.................... Performance Standards CLSI M02-A12.
for Antimicrobial Disk
Susceptibility Tests;
Approved Standards-
Twelfth Edition.
------------------------------------------------------------------------
H. Materials
------------------------------------------------------------------------
8-388.................... Implants for surgery-- ISO 6474-2 First
Ceramic materials--Part edition 2012-04-
2: Composite materials 15.
based on a high-purity
alumina matrix with
zirconia reinforcement.
8-389.................... Implants for surgery-- ISO 15309 First
Differential scanning edition 2013-12-
calorimetry of poly 01.
ether ether ketone
(PEEK) polymers and
compounds for use in
implantable medical
devices.
8-390.................... Standard Specification ASTM F1925-09.
for Semi-Crystalline
Poly(lactide) Polymer
and Copolymer Resins
for Surgical Implants.
8-391.................... Standard Specification ASTM F2313-10.
for Poly(glycolide) and
Poly(glycolide-co-
lactide) Resins for
Surgical Implants with
Mole Fractions Greater
Than or Equal To 70%
Glycolide.
------------------------------------------------------------------------
I. Nanotechnology
------------------------------------------------------------------------
18-4..................... Technical Specification-- ISO/TS 80004-6
Nanotechnologies--Vocab First edition 2013-
ulary--Part 6: Nano- 11-01.
object characterization.
------------------------------------------------------------------------
J. Neurology
------------------------------------------------------------------------
17-14.................... Transcutaneous ANSI/AAMI NS4:2013.
electrical nerve
stimulators.
------------------------------------------------------------------------

[[Page 48878]]

K. OB-GYN-GU/Gastroenterology
------------------------------------------------------------------------
9-103.................... Water treatment ANSI/AAMI
equipment for 26722:2014.
hemodialysis and
related therapies.
------------------------------------------------------------------------
L. Ophthalmic
------------------------------------------------------------------------
10-99.................... Anionic and non-ionic ISO 4311 First
surface active agents-- edition 1979-06-
Determination of 01.
critical micellization
concentration--Method
by measuring surface
tension with a plate,
stirrup, or ring,.
------------------------------------------------------------------------
M. Orthopedic
------------------------------------------------------------------------
11-293................... Standard Test Method for ASTM F2582-14.
Impingement of
Acetabular Prostheses.
11-294................... Standard Specification ASTM F1357-14.
for Articulating Total
Wrist Implants.
11-295................... Standard Practice for ASTM F2580-13.
Evaluation of Modular
Connection of
Proximally Fixed
Femoral Hip Prosthesis.
------------------------------------------------------------------------
N. Physical Medicine
------------------------------------------------------------------------
16-194................... Wheelchairs Part ISO 7176-25 First
25:Batteries and edition 2013-07-
chargers for powered 15.
wheelchairs.
------------------------------------------------------------------------
O. Radiology
------------------------------------------------------------------------
12-292................... IEEE Recommended IEEE Std 3333.2.1-
Practice for Three- 2015.
Dimensional (3D)
Medical Modeling.
------------------------------------------------------------------------
P. Software/Informatics
------------------------------------------------------------------------
13-73.................... Systematized IHTSDO SNOME-CT RF2
Nomenclature of Release 2015.
Medicine--Clinical
Terms.
13-74.................... Health informatics-- IEEE Std 11073-
Personal health device 10424-2014.
communication, Part
10424: Device
Specialization--Sleep
Apnoea Breathing
Therapy Equipment
(SABTE).
13-75.................... Health informatics-- ISO/IEEE 11073-
Point-of-care medical 10102 First
device communication-- edition 2014-03-
Part 10102: 01.
Nomenclature--Annotated
ECG.
13-76.................... Health informatics-- ISO 11073-91064
Standard communication First edition 2009-
protocol--Part 91064: 05-01.
Computer-assisted
electrocardiography.
13-77.................... Information technology-- ISO/IEC 29147 First
Security techniques-- edition 2014-02-
Vulnerability 15.
disclosure.
13-78.................... Information technology-- ISO/IEC 30111 First
Security techniques-- edition 2013-11-
Vulnerability handling 01.
processes.
------------------------------------------------------------------------
Q. Sterility
------------------------------------------------------------------------
14-478................... Flexible and semi-rigid ANSI/AAMI
endoscope processing in ST91:2015.
health care facilities.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

IV. List of Recognized Standards

FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
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

[[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

48872 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices

www.fda.gov/MedicalDevices/ MD 20993, 301–796–6287, standards@ Internet site. See section VI for
DeviceRegulationandGuidance/ cdrh.fda.gov. electronic access information. Interested
Standards/ucm123792.htm. See section SUPPLEMENTARY INFORMATION: persons should review the
VI for electronic access to the searchable supplementary information sheet for the
database for the current list of FDA I. Background standard to understand fully the extent
recognized consensus standards, Section 204 of the Food and Drug to which FDA recognizes the standard.
including Recognition List Number: 040 Administration Modernization Act of II. Modifications to the List of
modifications and other standards 1997 (Pub. L. 105–115) amended section Recognized Standards, Recognition List
related information. 514 of the Federal Food, Drug, and Number: 040
Submit written requests for a single Cosmetic Act (the FD&C Act) (21 U.S.C.
hard copy of the document entitled 360d). Amended section 514 allows FDA is announcing the addition,
‘‘Modifications to the List of Recognized FDA to recognize consensus standards withdrawal, correction, and revision of
Standards, Recognition List Number: developed by international and national certain consensus standards the Agency
040’’ to the Division of Industry and organizations for use in satisfying will recognize for use in premarket
Consumer Education, Center for Devices portions of device premarket review submissions and other requirements for
and Radiological Health, Food and Drug submissions or other requirements. devices. FDA will incorporate these
Administration, 10903 New Hampshire In a notice published in the Federal modifications in the list of FDA
Ave., Bldg. 66, Rm. 4613, Silver Spring, Register of February 25, 1998 (63 FR Recognized Consensus Standards in the
MD 20993–0002. Send one self- 9561), FDA announced the availability Agency’s searchable database. FDA will
addressed adhesive label to assist that of a guidance entitled ‘‘Recognition and use the term ‘‘Recognition List Number:
office in processing your request, or fax Use of Consensus Standards.’’ The 040’’ to identify these current
your request to 301–847–8149. notice described how FDA would modifications.
Submit electronic comments on this implement its standard recognition
In table 1, FDA describes the
document to http:// program and provided the initial list of
following modifications: (1) The
www.regulations.gov. Submit written recognized standards.
Modifications to the initial list of withdrawal of standards and their
comments to the Division of Dockets replacement by others, if applicable; (2)
recognized standards, as published in
Management (HFA–305), Food and Drug the correction of errors made by FDA in
the Federal Register, can be accessed at
Administration, 5630 Fishers Lane, Rm. listing previously recognized standards;
http://www.fda.gov/MedicalDevices/
1061, Rockville, MD 20852. Identify and (3) the changes to the
DeviceRegulationandGuidance/
comments with the docket number supplementary information sheets of
Standards/ucm123792.htm.
found in brackets in the heading of this These notices describe the addition, recognized standards that describe
document. withdrawal, and revision of certain revisions to the applicability of the
FOR FURTHER INFORMATION CONTACT: standards recognized by FDA. The standards.
Scott A. Colburn, Center for Devices and Agency maintains HTML and PDF In section III, FDA lists modifications
Radiological Health, Food and Drug versions of the list of FDA Recognized the Agency is making that involve the
Administration, 10903 New Hampshire Consensus Standards. Both versions are initial addition of standards not
Ave., Bldg. 66, Rm. 3632, Silver Spring, publicly accessible at the Agency’s previously recognized by FDA.

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Replacement
Old recognition recognition Title of standard 1 Change
No. No.

A. Anesthesia

1–46 .................. 1–103 ISO 5367 Fifth edition 2014–10–15 Anaesthetic and respiratory equip- Withdrawn and replaced with
ment—Breathing sets and connectors. newer version.
1–82 .................. ........................ IEC 60601–2–13 Edition 3.1 2009–08, Medical electrical equipment— Withdrawn. See 1–104.
Part 2–13: Particular requirements for the safety and essential per-
formance of anaesthetic systems.

B. Biocompatibility

2–179 ................ 2–220 ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of med- Withdrawn and replaced with
ical devices—Part 1:. newer version including Tech-
Evaluation and Testing within a risk management process [Including: nical Corrigendum.
Technical Corrigendum 1 (2010)].
2–208 ................ 2–215 USP 38–NF33:2015 <87> Biological Reactivity Test, In Vitro—Direct Withdrawn and replaced with
Contact Test. newer version.
2–209 ................ 2–216 USP 38–NF33:2015 <87> Biological Reactivity Test, In Vitro—Elution Withdrawn and replaced with
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Test. newer version.
2–210 ................ 2–217 USP 38–NF33:2015 <88> Biological Reactivity Tests, In Vivo, Proce- Withdrawn and replaced with
dure Preparation of Sample. newer version.
2–211 ................ 2–218 USP 38–NF33:2015 <88> Biological Reactivity Test, In Vitro, Classi- Withdrawn and replaced with
fication of Plastics—Intracutaneous Test. newer version.
2–212 ................ 2–219 USP 38–NF33:2015 <88> Biological Reactivity Tests, In Vivo, Classi- Withdrawn and replaced with
fication of Plastics—Systemic Injection Test. newer version.

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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48873

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.

C. Cardiovascular

3–76 .................. ........................ ASTM F2129–08 Standard Test Method for Conducting Cyclic Transferred. See 8–177.
Potentiodynamic Polarization Measurements to Determine The Cor-
rosion Susceptibility of Small Implant Devices.
3–117 ................ ........................ ANSI/AAMI/ISO 81060–2:2013 Non-invasive sphygmomanometers— Extent of recognition.
Part 2: Clinical validation of automated measurement type.
3–122 ................ ........................ ISO 81060–2 Second edition 2013–05–01 Non-invasive sphyg- Extent of recognition.
momanometers—Part 2: Clinical validation of automated measure-
ment type.

D. Dental/Ear, Nose, and Throat (ENT)

4–105 ................ ........................ ANSI/ADA Standard No.75 (Reaffirmed by ANSI: September 8, 2014) Reaffirmation.
Resilient Lining Materials For Removable Dentures, Part 1: Short-
Term Materials.
4–130 ................ ........................ ANSI/ADA Standard No. 17 (Reaffirmed by ANSI: September 8, 2014) Reaffirmation.
Denture Base Temporary Relining Resins.
4–150 ................ ........................ ANSI/ADA Specification No. 19–2004/ISO 4823:2000 (Reaffirmed by Reaffirmation.
ANSI: October 6, 2014) Dental Elastomeric Impression Materials.
4–184 ................ ........................ ANSI/ASA S3.25–2009 (Revision of ANSI S3.25–1989) (Reaffirmed by Reaffirmation.
ANSI September 11, 2014) American National Standard For an Oc-
cluded Ear Simulator.
4–191 ................ 4–220 ANSI/ASA S3.22–2014 AMERICAN NATIONAL STANDARD Speci- Withdrawn and replaced with
fication of Hearing Aid Characteristics. newer version.

E. General I (Quality Systems/Risk Management (QS/RM))

5–67 .................. ........................ ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of Withdrawn. See 5–96.
usability engineering to medical devices.
5–87 .................. ........................ IEC 62366 Edition 1.1 2014–01 Medical devices—Application of Withdrawn. See 5–95.
usability engineering to medical devices.
5–94 .................. ........................ AAMI/CN20 (PS):2014 Small-bore connectors for liquids and gases in Withdrawn. See 5–97.
healthcare applications—Part 20: Common test methods.

F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))

19–6 .................. ........................ IEC 60601–1–11 Edition 1.0 2010–04 Medical Electrical Equipment— Transition Period Added.
Part 1–11: General Requirements for Basic Safety and Essential
Performance—Collateral Standard: Requirements for Medical Elec-
trical Equipment and Medical Electrical Systems used in the Home
Healthcare Environment [Including: Technical Corrigendum 1 (2011)].

G. General Hospital/General Plastic Surgery (GH/GPS)

6–110 ................ ........................ ASTM F1441–03 (Reapproved 2014) Standard Specification for Soft- Reaffirmation.
Tissue Expander Devices.
6–185 ................ ........................ ASTM F881¥94 (Reapproved 2014) Standard Specification for Sili- Reaffirmation.
cone Elastomer Facial Implants.
6–200 ................ ........................ ASTM E1061–01 (Reapproved 2014) Standard Specification for Di- Reaffirmation.
rect-Reading Liquid Crystal Forehead Thermometers.
6–274 ................ 6–341 ISO 11608–1 Third Edition 2014–12–15 Needle-based injection sys- Withdrawn and replaced with
tems for medical use—Requirements and test methods—Part 1: newer version.
Needle-based injection systems.
6–301 ................ ........................ ISO 10555–1 Second Edition 2013–07–01 Sterile, single-use Extent of Recognition.
intravascular catheters—Part 1: General requirements.
6–308 ................ 6–342 IEC 80601–2–35 Edition 2.0 2009–10 Medical electrical equipment— Withdrawn and replaced with
Part 2–35: Particular requirements for the basic safety and essential newer version including Tech-
performance of heating devices using blankets, pads or mattresses nical Corrigendum.
and intended for heating in medical use [Including: Technical Corri-
asabaliauskas on DSK5VPTVN1PROD with NOTICES

gendum 1 (2012) and Technical Corrigendum 2 (2015)].
6–326 ................ 6–343 USP 38–NF 33:2015 Sodium Chloride Irrigation .................................... Withdrawn and replaced with
newer version.
6–327 ................ 6–344 USP 38–NF 33:2015 Sodium Chloride Injection ..................................... Withdrawn and replaced with
newer version.
6–328 ................ 6–345 USP 38–NF33:2015 Nonabsorbable Surgical Suture ............................. Withdrawn and replaced with
newer version.
6–329 ................ 6–346 USP 38–NF33:2015 <881> Tensile Strength ......................................... Withdrawn and replaced with
newer version.

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48874 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.

6–330 ................ 6–347 USP 38–NF33:2015 <861> Sutures—Diameter ..................................... Withdrawn and replaced with
newer version.
6–331 ................ 6–348 USP 38–NF33:2015 <871> Sutures—Needle Attachment ..................... Withdrawn and replaced with
newer version.
6–332 ................ 6–349 USP 38–NF33:2015 Sterile Water for Irrigation ...................................... Withdrawn and replaced with
newer version.
6–333 ................ 6–350 USP 38–NF33:2015 Heparin Lock Flush Solution .................................. Withdrawn and replaced with
newer version.
6–334 ................ 6–351 USP 38–NF33:2015 Absorbable Surgical Suture ................................... Withdrawn and replaced with
newer version.

H. In Vitro Diagnostics (IVD)

7–110 ................ 7–251 CLSI EP05–A3 Evaluation of Precision Performance of Quantitative Withdrawn and replaced with
Measurement Methods; Approved Guideline-Third Edition. newer version.
7–143 ................ 7–252 CLSI EP14–A3 Evaluation of Matrix Effects; Approved Guideline— Withdrawn and replaced with
Third Edition. newer version.
7–153 ................ 7–253 CLSI EP15–A3 User Verification of Performance for Precision and Es- Withdrawn and replaced with
timation of Bias; Approved Guideline-Third Edition. newer version.
7–230 ................ 7–254 CLSI M07–A10 Methods for Dilution Antimicrobial Susceptibility Tests Withdrawn and replaced with
for Bacteria that Grow Aerobically; Approved Standard—Ninth Edi- newer version.
tion.
7–123 ................ 7–255 CLSI MM09–A2 Nucleic Acid Sequencing Methods in Diagnostic Lab- Withdrawn and replaced with
oratory Medicine; Approved Guideline—Second Edition. newer version.
7–247 ................ 7–256 CLSI M100–S25 Performance Standards for Antimicrobial Suscepti- Withdrawn and replaced with
bility Testing; Twenty-Fifth Informational Supplement. newer version.

I. Materials

8–59 .................. 8–386 ISO 5832–4 Third edition 2014–09–15 Implants for surgery—Metallic Withdrawn and replaced newer
materials—Part 4: Cobalt-chromium-molybdenum casting alloy. version.
8–63 .................. 8–387 ISO 5832–11 Second edition 2014–09–15 Implants for surgery—Me- Withdrawn and replaced with
tallic materials—Part 11: Wrought titanium 6-aluminium 7-niobium newer version.
alloy.
8–177 ................ ........................ ASTM F2129–08 Standard Test Method for Conducting Cyclic Updated to incorporate transferred
Potentiodynamic Polarization Measurements to Determine the Cor- recognitions 3–76 and 17–9.
rosion Susceptibility of Small Implant Devices.

J. Neurology

17–9 .................. ........................ ASTM F2129–08 Standard Test Method for Conducting Cyclic Transferred. See 8–177.
Potentiodynamic Polarization Measurements to Determine the Cor-
rosion Susceptibility of Small Implant Devices.
17–4 .................. ........................ ASTM F647–94(2014) Standard Practice for Evaluating and Specifying Reaffirmation.
Implantable Shunt Assemblies for Neurosurgical Application.

K. Obstetrics-Gynecology-Urology-Gastroenterology (OB–GYN–GU)/Gastroenterology

9–73 .................. 9–104 ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and re- Withdrawn and replaced with
lated therapies. newer version.
9–97 .................. ........................ ISO 13958 Third edition 2014–04–01 Concentrates for haemodialysis Extent of recognition.
and related therapies.
9–69 .................. 9–105 ANSI/AAMI 13959:2014 Water for hemodialysis and related therapies Withdrawn and replaced with
newer version.
9–100 ................ ........................ ISO 11663 Second edition 2014–04–01 Quality of dialysis fluid for Extent of recognition.
haemodialysis and related therapies.
9–71 .................. 9–106 ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis Withdrawn and replaced with
and related therapies. newer version.
9–70 .................. 9–107 ANSI/AAMI 23500:2014 Guidance for the preparation and quality man- Withdrawn and replaced with
asabaliauskas on DSK5VPTVN1PROD with NOTICES

agement of fluids for hemodialysis and related therapies. newer version.
9–102 ................ ........................ ISO 4074 Second edition 2014–08–15 Natural latex rubber condoms— Extent of recognition.
Requirements and test methods.
9–90 .................. 9–108 ISO 8009 Second edition 2014–11–15 Mechanical contraceptives— Withdrawn and replaced with
Reusable natural and silicone rubber contraceptive diaphragms— newer version.
Requirements and tests.
9–56 .................. 9–109 ASTM D3492–08 Standard Specification for Rubber Contraceptives Withdrawn and replaced with
(Male Condoms). newer version.

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48876 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.

14–297 .............. 14–461 ANSI/AAMI/ISO 11137–1:2006/(R) 2010 Sterilization Of Health Care Withdrawn and replaced with
Products—Radiation—Part 1: Requirements For Development, Vali- newer version including Amend-
dation, And Routine Control Of A Sterilization Process For Medical ment.
Devices [Including: Amendment 1 (2013)].
14–300 .............. 14–462 ASTM D4169—14 Standard Practice for Performance Testing of Ship- Withdrawn and replaced with
ping Containers and Systems. newer version.
14–327 .............. ........................ ISO 11737–2 Second edition 2009–11–15 Sterilization of medical de- Extent of Recognition.
vices—Microbiological methods—Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization proc-
ess.
14–350 .............. ........................ ANSI/AAMI/ISO 13408–4:2005/(R)2014, Aseptic processing of health Reaffirmation.
care products—Part 4: Clean-in-place technologies.
14–353 .............. 14–460 ISO 11140–1 Third edition 2014–11–01 Sterilization of health care Withdrawn and replaced with
products—Chemical indicators—Part 1: General requirements. newer version.
14–391 .............. 14–463 ISO/ASTM 51608 Third edition 2015–03–15 Practice for dosimetry in Withdrawn and replaced with
an X-ray (bremsstrahlung) facility for radiation processing at ener- newer version.
gies between 50 KeV and 7.5 MeV.
14–392 .............. 14–464 ISO/ASTM 51649 Third edition 2015–03–15 Practice for dosimetry in Withdrawn and replaced with
an electron beam facility for radiation processing at energies be- newer version.
tween 300 keV and 25 MeV.
14–431 .............. 14–465 ISO/ASTM 51707 Third edition 2015–03–15 Guide for estimation of Withdrawn and replaced with
measurement uncertainty in dosimetry for radiation processing. newer version.
14–440 .............. 14–466 USP 38–NF33:2015 <61> Microbiological Examination of Nonsterile Withdrawn and replaced with
Products: Microbial Enumeration Tests. newer version.
14–441 .............. 14–467 USP 38–NF33:2015 <71> Sterility Tests ................................................ Withdrawn and replaced with
newer version.
14–442 .............. 14–468 USP 38–NF33:2015 <85> Bacterial Endotoxins Test ............................. Withdrawn and replaced with
newer version.
14–443 .............. 14–477 USP 38–NF33:2015 <151> Pyrogen Test (USP Rabbit Test) ............... Withdrawn and replaced with
newer version.
14–444 .............. 14–469 USP 38–NF33:2015 <161> Transfusion and Infusion Assemblies and Withdrawn and replaced with
Similar Medical Devices. newer version.
14–445 .............. 14–470 USP 38–NF33:2015 Biological Indicator for Steam Sterilization—Self Withdrawn and replaced with
Contained. newer version.
14–446 .............. 14–471 USP 38–NF33:2015 Biological Indicator for Dry-Heat Sterilization, Withdrawn and replaced with
Paper Carrier. newer version.
14–447 .............. 14–472 USP 38–NF33:2015 Biological Indicator for Ethylene Oxide Steriliza- Withdrawn and replaced with
tion, Paper Carrier. newer version.
14–448 .............. 14–473 USP 38–NF33:2015 Biological Indicator for Steam Sterilization, Paper Withdrawn and replaced with
Carrier. newer version.
14–449 .............. 14–474 USP 38–NF33:2015 <62> Microbiological Examination of Nonsterile Withdrawn and replaced with
Products: Tests for Specified Microorganisms. newer version.
14–450 .............. 14–475 USP 38–NF33:2015 <55> Biological Indicators—Resistance Perform- Withdrawn and replaced with
ance Tests. newer version.
14–451 .............. 14–476 USP 38–NF33:2015 <1035> Biological Indicators for Sterilization ........ Withdrawn 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 added as modifications to the list of
In table 2, FDA provides the listing of recognized standards under Recognition
new entries and consensus standards List Number: 040.

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and date

A. Anesthesia
asabaliauskas on DSK5VPTVN1PROD with NOTICES

1–104 ................. Medical electrical equipment—Part 2–13: Particular Requirements for basic safety ISO 80601–2–13 First Edition 2011–08–
and essential performance of an anaesthetic workstation [Including: Amend- 01 and Amendment 1 2015.
ment 1 (2015)].
1–105 ................. Medical electrical equipment—Part 2–72: Particular requirements for basic safety ISO 80601–2–72 First Edition 2015–04–
and essential performance of home healthcare environment ventilators for ven- 11.
tilator-dependent patients.

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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices 48877

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and date

B. Biocompatibility

2–221 ................. Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements .. ANSI/AAMI/ISO 10993–2:2006 (R2014).
2–222 ................. Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements .. ISO 10993–2 Second edition 2006–07–
15.

C. Cardiovascular

3–135 ................. Cardiovascular implants and extracorporeal systems—Vascular device-drug com- ISO/TS 12417–1 First edition 2011–06–
bination products. 01.
3–136 ................. Cardiovascular implants and extracorporeal systems—Vascular device-drug com- ANSI/AAMI/ISO TIR12417:2011.
bination products.
3–137 ................. Standard Guide for Testing Absorbable Stents ........................................................ ASTM F3036–13.
3–138 ................. Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of ASTM F2942–13.
Vascular Stents.
3–139 ................. Active implantable medical devices—Electromagnetic compatibility—EMC test ISO 14117 First edition 2012–07–15.
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: Application of usability engineering to medical devices .. IEC 62366–1 Edition 1.0 2015–02.
5–96 ................... Medical devices—Part 1: Application of usability engineering to medical devices .. ANSI/AAMI/IEC 62366–1:2015.
5–97 ................... Small-bore connectors for liquids and gases in healthcare applications—Part 20: ISO 80369–20 First edition 2015–05–15.
Common test methods.

E. General II (ES/EMC)

19–14 ................. Medical electrical equipment—Part 1–11: General requirements for basic safety IEC 60601–1–11 Edition 2.0 2015–01.
and essential performance—Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment.
19–15 ................. Medical electrical equipment—Part 1–12: General requirements for basic safety IEC 60601–1–12 Edition 1.0 2014–06.
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 for Implantable Breast Prostheses ....................................... ASTM F703–07.
6–353 ................. Standard Specification for Implantable Saline Filled Breast Prosthesis ................... ASTM F2051¥00 (Reapproved 2014).
6–354 ................. Standard Specification for Radiation Attenuating Protective Gloves ........................ ASTM D7866–14.

G. IVD

7–257 ................. Principles and procedures for Detection of Anaerobes in Clinical Specimens; Ap- CLSI M56–A.
proved Guideline.
7–258 ................. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved CLSI M02–A12.
Standards- Twelfth Edition.

H. Materials

8–388 ................. Implants for surgery—Ceramic materials—Part 2: Composite materials based on ISO 6474–2 First edition 2012–04–15.
a high-purity alumina matrix with zirconia reinforcement.
8–389 ................. Implants for surgery—Differential scanning calorimetry of poly ether ether ketone ISO 15309 First edition 2013–12–01.
(PEEK) polymers and compounds for use in implantable medical devices.
8–390 ................. Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer ASTM F1925–09.
Resins for Surgical Implants.
8–391 ................. Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for ASTM F2313–10.
Surgical Implants with Mole Fractions Greater Than or Equal To 70% Glycolide.
asabaliauskas on DSK5VPTVN1PROD with NOTICES

I. Nanotechnology

18–4 ................... Technical Specification—Nanotechnologies—Vocabulary—Part 6: Nano-object ISO/TS 80004–6 First edition 2013–11–
characterization. 01.

J. Neurology

17–14 ................. Transcutaneous electrical nerve stimulators ............................................................. ANSI/AAMI NS4:2013.

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit electronic or written comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document.
Contact		Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796- 6287, [email protected]
FR Citation		80 FR 48871

80 FR 48871 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 157 (August 14, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration