[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50114-50121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20323]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 029
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: 029'' (Recognition List Number: 029), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies of ``Modifications
to the List of Recognized Standards, Recognition List Number: 029'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993. Send two self-addressed adhesive labels to assist that office in
processing your requests, or fax your request to 301-847-8149. Submit
written comments concerning this document, or recommendations for
additional standards for recognition, to the contact person (see FOR
FURTHER INFORMATION CONTACT). Submit electronic comments by email:
standards@cdrh.fda.gov. This document may also be accessed on FDA's
Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section
[[Page 50115]]
VI of this document for electronic access to the searchable database
for the current list of FDA recognized consensus standards, including
Recognition List Number: 029 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993, 301-796-
6574.
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its 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, are identified in table 1 of this
document.
Table 1--Previous Publication of Standard Recognition Lists
------------------------------------------------------------------------
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February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
May 7, 2001 (66 FR 23032).
January 14, 2002 (67 FR 1774).
October 2, 2002 (67 FR 61893).
April 28, 2003 (68 FR 22391).
March 8, 2004 (69 FR 10712).
June 18, 2004 (69 FR 34176).
October 4, 2004 (69 FR 59240).
May 27, 2005 (70 FR 30756).
November 8, 2005 (70 FR 67713).
March 31, 2006 (71 FR 16313).
June 23, 2006 (71 FR 36121).
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March, 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
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These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the Agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 029
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in satisfying premarket reviews 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: 029'' to identify these current
modifications.
In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (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 of this document, FDA lists modifications the Agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 2--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement recognition
Old recognition No. No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-115..................... 2-189..................... ASTM F895-11 Standard Test Withdrawn and replaced
Method for Agar Diffusion with newer version.
Cell Culture Screening for
Cytotoxicity.
2-164..................... 2-190..................... ANSI/AAMI/ISO 10993-13:2010 Withdrawn and replaced
Biological evaluation of with newer version.
medical devices--Part 13:
Identification and
quantification of degradation
products from polymeric
medical devices.
2-165..................... .......................... ANSI/AAMI/ISO 10993-14:2001/ Reaffirmation.
(R)2011 Biological evaluation
of medical devices--Part 14:
Identification and
quantification of degradation
products from ceramics.
----------------------------------------------------------------------------------------------------------------
B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-37...................... 1-87...................... IEC 60601-2-23(1999-12) Transferred to
Medical electrical equipment-- Anesthesia.
Part 2-23: Particular
requirements for the safety,
including essential
performance, of
transcutaneous partial
pressure monitoring equipment.
3-44...................... .......................... ANSI/AAMI BP22:1994/(R)2011 Reaffirmation.
Blood pressure transducers.
3-55...................... .......................... ASTM F1830-97 (Reapproved Extent of recognition.
2005) Standard Practice for
Selection of Blood for in
vitro Evaluation of Blood
Pumps.
3-56...................... .......................... ASTM F1841-97 (Reapproved Extent of recognition.
2005) Standard Practice for
Assessment of Hemolysis in
Continuous Flow Blood Pumps.
[[Page 50116]]
3-62...................... 3-102..................... IEC 60601-2-31 Edition 2.1 Withdrawn and replaced
2011-09 Medical electrical with newer version.
equipment--Part 2-31:
Particular requirements for
the basic safety and
essential performance of
external cardiac pacemakers
with internal power source.
----------------------------------------------------------------------------------------------------------------
C. General
----------------------------------------------------------------------------------------------------------------
5-28...................... .......................... IEC 60601-1-2, (Second Withdrawn.
Edition, 2001), Medical
Electrical Equipment--Part 1-
2: General Requirements for
Safety--Collateral Standard:
Electromagnetic
Compatibility--Requirements
and Tests.
5-30...................... .......................... ANSI/AAMI/IEC 60601-1-2:2001, Withdrawn.
Medical Electrical Equipment--
Part 1-2: General
Requirements for Safety--
Collateral Standard:
Electromagnetic
Compatibility--Requirements
and Tests.
5-40...................... .......................... ISO 14971 Second edition 2007- Extent of recognition.
03-01, Medical devices--
Application of risk
management to medical devices.
5-52...................... 5-71...................... ANSI/AAMI ES60601-1:2005/ Withdrawn and replaced
(R)2012 and C1:2009/(R)2012 with new version.
and A2:2010/(R)2012
(Consolidated Text), Medical
electrical equipment--Part 1:
General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD).
5-56...................... .......................... ISO 15223-2 First edition 2010- Contact person.
01-15, Medical devices--
Symbols to be used with
medical devices labels,
labeling, and information to
be supplied--Part 2: Symbol
development, selection and
validation.
5-59...................... 5-72...................... ISO/FDIS 15223-1 2012 Medical Withdrawn and replaced
devices--Symbols to be used with new version.
with medical device labels,
labeling and information to
be supplied--Part 1: General
requirements.
5-61...................... .......................... ANSI/AAMI/ISO 15223-1:2007, Withdrawn.
Medical devices--Symbols to
be used with medical device
labels, labeling, and
information to be supplied--
Part 1: General requirements.
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-110..................... .......................... ASTM F 882-84 (Reapproved Withdrawn.
2002), Standard Performance
and Safety Specification for
Cryosurgical Medical
Instruments.
6-114..................... 6-274..................... ISO 11608-1 Second edition Withdrawn and replaced
2012-04-01 Needle-based with newer version.
injection systems for medical
use--Requirements and test
methods--Part 1: Needle-based
injection systems.
6-115..................... 6-275..................... ISO 11608-2 Second edition Withdrawn and replaced
2012-04-01 Needle-based with newer version.
injection systems for medical
use--Requirements and test
methods--Part 2: Needles.
6-117..................... .......................... ASTM F2172-02 (Reapproved Contact person.
2011), Standard Specification
for Blood/Intravenous Fluid/
Irrigation Fluid Warmers.
6-118..................... .......................... ASTM F2196-02, Standard Withdrawn. See 6-238.
Specification for Circulating
Liquid and Forced Air Patient
Temperature Management
Devices.
6-119..................... .......................... ANSI/AAMI BF7:1989/(R)2011 Reaffirmation.
Blood transfusion
microfilters.
6-132..................... .......................... ISO 11810-1 First edition 2005- Contact person.
02-15, Lasers and laser-
related equipment--Test
method and classification for
the laser-resistance of
surgical drapes and/or
patient-protective covers--
Part 1: Primary ignition and
penetration.
6-172..................... 6-276..................... ISO 8536-1 Fourth edition 2011- Withdrawn and replaced
09-01 Infusion equipment for with newer version.
medical use--Part 1: Infusion
glass bottles.
6-175..................... .......................... ASTM D5151-06 (Reapproved Reaffirmation.
2011) Standard Test Method
for Detection of Holes in
Medical Gloves.
6-178..................... .......................... ASTM D6124-06 (Reapproved Reaffirmation and
2011) Standard Test Method Contact person.
for Residual Powder on
Medical Gloves.
6-183..................... .......................... ASTM D5250-06 (Reapproved Reaffirmation and
2011) Standard Specification contact person.
for Poly(vinyl chloride)
Gloves for Medical
Application.
6-202..................... .......................... ISO 11810-2:2007, Lasers and Title and contact
laser-related equipment--Test person.
method and classification for
the laser-resistance of
surgical drapes and/or
patient-protective covers--
Part 2: Secondary ignition.
6-236..................... .......................... IEC 80601-2-59 Edition 1.0 Title and contact
2008-10 Medical electrical person.
equipment--Part 2-59:
Particular requirements for
the basic safety and
essential performance of
screening thermographs for
human febrile temperature
screening.
6-237..................... .......................... IEC 80601-2-59 (First edition-- Title and contact
2008) Medical electrical person.
equipment--Part 2-59:
Particular requirements for
the basic safety and
essential performance of
screening thermographs for
human febrile temperature
screening CORRIGENDUM1.
6-238..................... .......................... IEC 80601-2-35 Edition 2.0 Contact person.
2009-10, Medical electrical
equipment--Part 2-35:
Particular requirements for
the basic safety and
essential performance of
heating devices using
blankets, pads or mattresses
and intended for heating in
medical use.
[[Page 50117]]
6-241..................... .......................... ISO 1135-4 Fourth edition 2010- Contact person.
04-15, Transfusion equipment
for medical use--Part 4:
Transfusion sets for single
use.
6-242..................... .......................... ISO 8536-2 Third edition 2010- Contact person.
03-15, Infusion equipment for
medical use--Part 2: Closures
for infusion bottles.
6-245..................... .......................... ISO 8536-4 Fifth edition 2010- Contact person.
10-01, Infusion equipment for
medical use--Part 4: Infusion
sets for single use, gravity
feed.
6-273..................... .......................... ISO 23908 First edition 2011- Contact person.
06-11, Sharps injury
protection--Requirements and
test methods--Sharps
protection features for
single-use hypodermic
needles, introducers for
catheters and needles used
for blood sampling.
----------------------------------------------------------------------------------------------------------------
E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-54...................... .......................... CLSI D12-A2, Immunoprecipitin Withdrawn.
Analyses: Procedures for
Evaluating the Performance of
Materials--Second Edition;
Approved Guideline.
7-76...................... .......................... NCCLS M15-A, Laboratory Contact person and type
Diagnosis of Blood-borne of standard.
Parasitic Diseases; Approved
Guideline.
7-146..................... .......................... CLSI M6-A2, Protocols for Contact person and
Evaluating Dehydrated Mueller- title.
Hinton Agar; Approved
Standard--Second Edition.
7-148..................... .......................... CLSI M28-A2, Procedures for Contact person and
the Recovery and title.
Identification of Parasites
From the Intestinal Tract;
Approved Guideline--Second
Edition.
7-157..................... 7-228..................... CLSI M11-A8, Methods for Withdrawn and replaced
Antimicrobial Susceptibility with newer version.
Testing of Anaerobic
Bacteria; Approved Standard-
Eighth Edition.
7-171..................... .......................... CLSI M38-A2, Reference Method Contact person and
for Broth Dilution Antifungal title.
Susceptibility Testing of
Filamentous Fungi; Approved
Standard--Second Edition.
7-179..................... .......................... CLSI M27-S3, Reference Method Contact person and
for Broth Dilution Antifungal title.
Susceptibility Testing of
Yeasts; Third Informational
Supplement.
7-184..................... .......................... CLSI M40-A, Quality Control of Contact person and
Microbiological Transport title.
Systems; Approved Standard.
7-195..................... 7-229..................... CLSI M02-A11, Performance Withdrawn and replaced
Standards for Antimicrobial with newer version.
Disk Susceptibility Tests;
Approved Standard--Eleventh
Edition.
7-196..................... 7-230..................... CLSI M07-A9, Methods for Withdrawn and replaced
Dilution Antimicrobial with newer version.
Susceptibility Tests for
Bacteria That Grow
Aerobically; Approved
Standard--Ninth Edition.
7-197..................... .......................... CLSI M35-A2, Abbreviated Contact person and
Identification of Bacteria title.
and Yeast; Approved
Guideline--Second Edition.
7-198..................... .......................... CLSI M23-A3, Development of In Contact person and
Vitro Susceptibility Testing title.
Criteria and Quality Control
Parameters; Approved
Guideline--Third Edition.
7-200..................... .......................... CLSI M48-A, Laboratory Contact person and
Detection and Identification title.
of Mycobacteria; Approved
Guideline.
7-215..................... .......................... CLSI M44-A2, Method for Contact person.
Antifungal Disk Diffusion
Susceptibility Testing of
Yeast; Approved Guideline-
Second Edition.
7-216..................... 7-231..................... CLSI M100-S22, Performance Withdrawn and replaced
Standards for Antimicrobial with newer version.
Susceptibility Testing;
Twenty-Second Informational
Supplement.
7-217..................... .......................... CLSI M44-S3, Zone Diameter Contact person.
Interpretive Standards,
Corresponding Minimal
Inhibitory Concentration
(MIC) Interpretive
Breakpoints, and Quality
Control Limits for Antifungal
Disk Diffusion Susceptibility
Testing of Yeasts; Third
Informational Supplement.
7-218..................... .......................... CLSI M45-A2, Methods for Contact person.
Antimicrobial Dilution and
Disk Susceptibility Testing
of Infrequently Isolated or
Fastidious Bacteria; Approved
Guideline--Second Edition.
----------------------------------------------------------------------------------------------------------------
F. Materials
----------------------------------------------------------------------------------------------------------------
8-108..................... 8-216..................... ASTM F1295-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-6Aluminum-7Niobium
Alloy for Surgical Implant
Applications (UNS R56700).
8-111..................... .......................... ASTM F1160-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Shear and Bending Fatigue
Testing of Calcium Phosphate
and Metallic Medical and
Composite Calcium Phosphate/
Metallic Coatings.
8-112..................... .......................... ASTM F1044-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Shear Testing of Calcium
Phosphate Coatings and
Metallic Coatings.
8-113..................... .......................... ASTM F1147-05 (Reapproved Reaffirmation.
2011) Standard Test Method
for Tension Testing of
Calcium Phosphate and
Metallic Coatings.
8-127..................... .......................... ISO 5834-2:2006, Implants for Withdrawn. See 8-208.
surgery--Ultra-high-molecular-
weight polyethylene--Part 2:
Moulded forms.
8-128..................... .......................... ASTM F2213-06 (Reapproved Reaffirmation and
2011) Standard Test Method relevant guidance.
for Measurement of
Magnetically Induced Torque
on Medical Devices in the
Magnetic Resonance
Environment.
[[Page 50118]]
8-130..................... 8-217..................... ASTM F620-11 Standard Withdrawn and replaced
Specification for Titanium with newer version.
Alloy Forgings for Surgical
Implants in the Alpha Plus
Beta Condition.
8-131..................... 8-218..................... ASTM F799-11 Standard Withdrawn and replaced
Specification for Cobalt- with newer version.
28Chromium-6Molybdenum Alloy
Forgings for Surgical
Implants (UNS R31537, R31538,
R31539).
8-164..................... 8-219..................... ASTM F136-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-6Aluminum-4Vanadium
ELI (Extra Low Interstitial)
Alloy for Surgical Implant
Applications (UNS R56401).
8-174..................... 8-220..................... ASTM F629-11 Standard Practice Withdrawn and replaced
for Radiography of Cast with newer version.
Metallic Surgical Implants.
8-180..................... 8-221..................... ASTM F2066-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Titanium-15 Molybdenum Alloy
for Surgical Implant
Applications (UNS R58150).
8-182..................... 8-222..................... ASTM F1537-11 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-28Chromium-6Molybdenum
Alloys for Surgical Implants
(UNS R31537, UNS R31538, and
UNS R31539).
8-186..................... 8-223..................... ASTM F2759-11 Standard Guide Withdrawn and replaced
for Assessment of the Ultra with newer version.
High Molecular Weight
Polyethylene (UHMWPE) Used in
Orthopedic and Spinal Devices.
8-210..................... 8-227..................... ASTM F2182-11a Standard Test Withdrawn and replaced
Method for Measurement of with newer version.
Radio Frequency Induced
Heating On or Near Passive
Implants During Magnetic
Resonance Imaging.
----------------------------------------------------------------------------------------------------------------
G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-175.................... .......................... ASTM F1582-98 (Reapproved Reaffirmation.
2011) Standard Terminology
Relating to Spinal Implants.
11-185.................... .......................... ASTM F2267-04 (Reapproved Reaffirmation.
2011) Standard Test Method
for Measuring Load Induced
Subsidence of Intervertebral
Body Fusion Device Under
Static Axial Compression.
11-186.................... 11-235.................... ASTM F2077-11 Test Methods For Withdrawn and replaced
Intervertebral Body Fusion with newer version.
Devices.
11-195.................... .......................... ASTM F1612-95 (2005), Standard Withdrawn. See 11-225.
Practice for Cyclic Fatigue
Testing of Metallic Stemmed
Hip Arthroplasty Femoral
Components with Torsion.
11-203.................... .......................... ASTM F1541-02 (Reapproved Reaffirmation and
2011) Standard Specification contact person.
and Test Methods for External
Skeletal Fixation Devices.
11-220.................... .......................... ASTM F2068-09, Standard Extent of recognition
Specification for Femoral and CFR citations.
Prostheses--Metallic Implants.
11-230.................... 11-236.................... ASTM F1717-11a Standard Test Withdrawn and replaced
Methods for Spinal Implant with newer version.
Constructs in a Vertebrectomy
Model.
----------------------------------------------------------------------------------------------------------------
H. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-172.................... .......................... ANSI/RESNA WC/Volume 1--1998, Duplicate. See 16-188.
Section 5: Determination of
Overall Dimensions, Mass, and
Turning Space--Wheelchair.
16-186.................... 16-189.................... ASME A18.1-2011 (Revision of Withdrawn and replaced
ASME A18.1-2008) Safety with newer version.
Standard for Platform Lifts
and Stairway Chairlifts.
----------------------------------------------------------------------------------------------------------------
I. Radiology
----------------------------------------------------------------------------------------------------------------
12-102.................... .......................... ANSI/IESNA RP-27.2-00 CFR citation and product
Recommended Practice for codes, devices
Photobiological Safety for affected, processes
Lamps & Lamp Systems-- impacted, and contact
Measurement Techniques. person.
12-153.................... .......................... ANSI/IESNA RP-27.1-05 CFR citation and product
Recommended Practice for codes, devices
Photobiological Safety for affected, processes
Lamps and Lamp Systems-- impacted, and contact
General Requirements. person.
12-179.................... .......................... ANSI/IESNA RP-27.3-07 Extent of recognition,
Recommended Practice for CFR citation and
Photobiological Safety for product codes, devices
Lamps--Risk Group affected, processes
Classification and Labeling. impacted, type of
standard, contact
person, and relevant
guidance.
----------------------------------------------------------------------------------------------------------------
J. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8...................... .......................... IEC 62304 First edition 2006- Extent of recognition.
05 Medical device software--
Software life cycle processes.
----------------------------------------------------------------------------------------------------------------
[[Page 50119]]
K. Sterility
----------------------------------------------------------------------------------------------------------------
14-55..................... 14-358.................... ANSI/AAMI/ISO 14160:2011 Withdrawn and replaced
Sterilization of health care with newer version.
products--Liquid chemical
sterilizing agents for single-
use medical devices utilizing
animal tissues and their
derivatives--Requirements for
characterization,
development, validation and
routine control of a
sterilization process for
medical devices.
14-123.................... 14-359.................... ASTM F2096-11 Standard Test Withdrawn and replaced
Method for Detecting Gross with newer version.
Leaks in Packaging by
Internal Pressurization
(Bubble Test).
14-227.................... .......................... ANSI/AAMI/ISO 11737-1:2006 (R) Reaffirmation and
2011, Sterilization of health contact person.
care products--
Microbiological methods--Part
1: Determination of the
population of microorganisms
on product.
14-229.................... .......................... ASTM F1980-07 (Reapproved Reaffirmation.
2011) Standard Guide for
Accelerated Aging of Sterile
Barrier Systems for Medical
Devices.
14-264.................... .......................... AAMI/ANSI ST8:2008, Hospital Contact person.
steam sterilizers.
14-277.................... .......................... ISO TS 17665-2:2009, Extent of recognition
Sterilization of health care and contact person.
products--Moist heat--Part 2:
Guidance on the application
of ISO 17665-1.
14-292.................... 14-360.................... ANSI/AAMI ST72:2011 Bacterial Withdrawn and replaced
endotoxins--Test methods, with newer version.
routine monitoring, and
alternatives to batch testing.
14-311.................... .......................... AAMI/ANSI ST55:2010, Table-top Contact person.
steam sterilizers.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
Listing of New Entries
In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 029.
Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-86.................. Respiratory tract ISO 8185 Third
humidifiers for medical edition 2007-07-01.
use--Particular
requirements for
respiratory
humidification systems.
1-87.................. Medical electrical 60601-2-23 Edition
equipment--Part 2-23: 3.0 2011-02.
Particular requirements
for the basic safety and
essential performance of
transcutaneous partial
pressure monitoring
equipment.
1-88.................. Medical electrical ISO 80601-2-12 First
equipment--Part 2-12: edition 2011-04-15.
Particular requirements
for basic safety and
essential performance of
critical care ventilators.
1-89.................. Medical electrical ISO 80601-2-12:2011
equipment--Part 2-12: TECHNICAL
Particular requirements CORRIGENDUM 1.
for basic safety and
essential performance of
critical care ventilators.
------------------------------------------------------------------------
B. Cardiovascular
------------------------------------------------------------------------
3-101................. Medical electrical ANSI/AAMI/IEC 60601-
equipment--Part 2-27: 2-27:2011.
Particular requirements
for the basic safety and
essential performance of
electrocardiographic
monitoring equipment.
3-103................. Cardiovascular implants-- ISO 25539-3 First
Endovascular devices-- edition 2011-12-01.
Part 3: Vena cava filters.
3-104................. Standard Guide for ASTM F2914-12.
Identification of Shelf-
life Test Attributes for
Endovascular Devices.
------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-277................. Prefilled syringes--Part ISO 11040-4 Second
4: Glass barrels for edition 2007-02-01.
injectables.
6-278................. Prefilled syringes--Part ISO 11040-5 Third
5: Plunger stoppers for edition 2012-01-15.
injectables.
6-279................. Medical electrical IEC 60601-2-19
equipment--Part 2-19: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
infant incubators
CORRIGENDUM 1.
6-280................. Medical electrical IEC 60601-2-20
equipment--Part 2-20: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
infant transport
incubators CORRIGENDUM 1.
6-281................. Medical electrical IEC 80601-2-35
equipment--Part 2-35: (Second edition--
Particular requirements 2009).
for the basic safety and
essential performance of
heating devices using
blankets, pads or
mattresses and intended
for heating in medical
use CORRIGENDUM 1.
------------------------------------------------------------------------
D. Materials
------------------------------------------------------------------------
8-224................. Standard Guide for ASTM F2102--06
Evaluating the Extent of [euro]\1\.
Oxidation in Ultra-High-
Molecular-Weight
Polyethylene Fabricated
Forms Intended for
Surgical Implants.
[[Page 50120]]
8-225................. Standard Practice for ASTM F2003--02
Accelerated Aging of (Reapproved 2008).
Ultra-High Molecular
Weight Polyethylene after
Gamma Irradiation in Air.
8-226................. Standard Specification for ASTM F603--12.
High-Purity Dense
Aluminum Oxide for
Medical Application.
------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-75.................. Optics and Optical ISO 8600-3 First
instruments--Medical edition 1997-07-01.
endoscopes and endoscopic
accessories--Part 3:
Determination of field of
view and direction of
view of endoscopes with
optics.
9-76.................. Water for haemodialysis ISO 13959 Second
and related therapies. edition 2009-04-15.
9-77.................. Guidance for the ISO 23500 First
preparation and quality edition 2011-05-15.
management of fluids for
haemodialysis and related
therapies.
9-78.................. Quality of dialysis fluid ISO 11663 First
for haemodialysis and edition 2009-04-15.
related therapies.
------------------------------------------------------------------------
F. Ophthalmic
------------------------------------------------------------------------
10-73................. American National Standard ANSI Z80.21-2010.
for Ophthalmics--
Instruments--General-
Purpose Clinical Visual
Acuity Charts.
10-74................. Ophthalmic instruments-- ISO 10940 Second
Fundus cameras. edition 2009-08-01.
------------------------------------------------------------------------
G. Orthopedic
------------------------------------------------------------------------
11-237................ Implants for surgery-- ISO 7206-6 First
Partial and total hip edition 1992-03-l5.
joint prostheses--Part 6:
Determination of
endurance properties of
head and neck region of
stemmed femoral
components.
11-238................ Standard Specification for ASTM F 2033-12.
Total Hip Joint
Prosthesis and Hip
Endoprosthesis Bearing
Surfaces Made of
Metallic, Ceramic, and
Polymeric Materials.
11-239................ Standard Test Methods for ASTM F2345-03
Determination of Static (Reapproved 2008).
and Cyclic Fatigue
Strength of Ceramic
Modular Femoral Heads.
11-240................ Standard Specification and ASTM F382-99
Test Method for Metallic (Reapproved 2008).
Bone Plates.
11-241................ Standard Specification and ASTM F543-07
Test Methods for Metallic [euro]\1\.
Medical Bone Screws.
11-242................ Standard Specification for ASTM F1839-08
Rigid Polyurethane Foam [euro]\2\.
for Use as a Standard
Material for Testing
Orthopaedic Devices and
Instruments.
11-243................ Standard Test Methods for ASTM F2346-05
Static and Dynamic (Reapproved 2011).
Characterization of
Spinal Artificial Discs.
------------------------------------------------------------------------
H. Radiology
------------------------------------------------------------------------
12-249................ Photobiological safety of IEC 62471 First
lamps and lamp systems. edition 2006-07.
------------------------------------------------------------------------
I. Software/Informatics
------------------------------------------------------------------------
13-31................. Specimen Labels: Content CLSI AUTO12-A.
and Location, Fonts, and
Label Orientation;
Approved Standard.
13-32................. Medical device software-- ANSI/AAMI/IEC
Software life cycle 62304:2006.
processes.
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
14-361................ Sterilization of health ISO 14160 Second
care products--Liquid edition 2011-07-01.
chemical sterilizing
agents for single-use
medical devices utilizing
animal tissues and their
derivatives--Requirements
for characterization,
development, validation
and routine control of a
sterilization process for
medical devices.
------------------------------------------------------------------------
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 minor 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 minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the FD&C Act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). 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
[[Page 50121]]
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. 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 includes
the guidance as well as the current list of recognized standards and
other standards-related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 029'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
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.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments
regarding this document. It is no longer necessary to send two copies
of mailed comments. Comments are to be identified with the docket
number found in brackets in the heading of this document. 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: 029. These modifications to the list of
recognized standards are effective upon publication of this notice in
the Federal Register.
Dated: August 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20323 Filed 8-17-12; 8:45 am]
BILLING CODE 4160-01-P