[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2453-2458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00477]
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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: 033
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: 033'' (``Recognition List Number: 033''), will assist
manufacturers who elect to declare conformity with consensus standards
to meet certain requirements for medical devices.
DATES: Submit either electronic or written 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 the document
entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 033'' 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, Rm. 4613, Silver Spring, MD 20993-0002. Send two self-
addressed adhesive labels to assist that office in processing your
requests, or fax your request to 301-847-8149.
Submit electronic comments concerning this document, or
recommendations for additional standards for recognition, by email to
standards@cdrh.fda.gov. Submit written comments to the contact person
(see FOR FURTHER INFORMATION CONTACT). This document may also be
accessed on FDA's Internet site at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 033 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. 3632, Silver Spring, MD 20993-0002, 301-
796-6287.
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 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
[[Page 2454]]
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: 033
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. We
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database, using the term
``Recognition List Number: 033'' to identify these current
modifications.
In table 1 of this document, 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 of this document, 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
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Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
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A. Anesthesia
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1-60.................................. .............. IEC 60601-2-12 (2001-10) Withdrawn. Transition
Medical electrical equipment-- period expired. See 1-
Part 2-12: Particular 88.
requirements for the safety
of lung ventilators--Critical
care ventilators.
1-61.................................. .............. IEC 60601-2-13 (2003-05) Withdrawn. Transition
Medical electrical equipment-- period expired. See 1-
Part 2-13: Particular 82.
requirements for the safety
and essential performance of
anesthetic systems.
1-66.................................. .............. ISO 9919:2005 Medical Withdrawn. Transition
electrical equipment-- period expired. See 1-
Particular requirements for 85.
the basic safety and
essential performance of
pulse oximeter equipment for
medical use.
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B. Cardiovascular
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3-38.................................. .............. IEC 60601-2-34 (2000-10) Withdrawn. Transition
Medical electrical equipment-- period expired. See 3-
Part 2-34: Particular 115.
requirements for the safety,
including essential
performance, of invasive
blood pressure monitoring
equipment.
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C. Dental/ENT
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4-122................................. .............. IEC 60601-2-18:1996 Amendment Withdrawn. Transition
1 2000 Medical electrical period expired. See 4-
equipment--Part 2-18: 187.
Particular requirements for
the safety of endoscopic
equipment.
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D. General
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5-4................................... .............. IEC 60601-1 1988; Amendment 1, Withdrawn. Transition
1991-11, Amendment 2, 1995 period expired. See 5-
Medical electrical equipment-- 77.
Part 1: General requirements
for safety and essential
performance.
5-27.................................. .............. IEC 60601-1-1:2000 Medical Withdrawn.
electrical equipment--Part 1-
1: General requirements for
safety--Collateral standard:
Safety requirements for
medical electrical systems.
5-34.................................. .............. IEC 60601-1-2 Medical Withdrawn. Transition
electrical equipment--Part 1- period expired. See 5-
2: General requirements for 53.
safety--Collateral standard:
Electromagnetic
compatibility--Requirements
and tests (Edition 2:2001
with Amendment 1:2004;
Edition 2.1) (Edition 2:2001
consolidated with Amendment
1:2004).
5-35.................................. .............. ANSI/AAMI/IEC 60601-1-2:2001 Withdrawn. Transition
Medical electrical equipment-- period expired. See 5-
Part 1-2: General 54.
requirements for safety--
Collateral standard:
Electromagnetic
compatibility--Requirements
and tests.
5-41.................................. .............. IEC 60601-1-4 Edition 1.1 2000- Withdrawn.
04 Medical electrical
equipment--Part 1-4: General
requirements for safety--
Collateral standard:
Programmable electrical
medical systems.
[[Page 2455]]
5-49.................................. .............. IEC 60601-1-8 First edition Withdrawn. Transition
2003-08 Medical electrical period expired. See 5-
equipment--Part 1-8: General 76.
requirements for safety--
Collateral standard: General
requirements, tests, and
guidance for alarm systems in
medical electrical equipment
and medical electrical
systems.
5-60.................................. .............. IEC 60601-1-2 Int. 1 Third Withdrawn. See 5-53.
edition/I-SH 01:2007 Medical
electrical equipment--Part 1-
2: General requirements for
basic safety and essential
performance--Collateral
standard: Electromagnetic
compatibility--Requirements
and tests, interpretation
sheet.
5-77.................................. .............. ANSI/AAMI ES60601-1:2005/ Transition period
(R)2012 and A1:2012, C1:2009/ extended.
(R)2012 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).
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E. General Hospital/General Plastic Surgery
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6-9................................... .............. IEC 60601-2-21 First edition Withdrawn. Transition
1994-02 Medical electrical period expired. See 6-
equipment--Part 2: Particular 300.
requirements for the safety
of infant radiant warmers.
6-29.................................. .............. IEC 60601-2-19 First edition Withdrawn. Transition
1990-12 Medical electrical period expired. See 6-
equipment--Part 2: Particular 298.
requirements for safety of
baby incubators.
6-32.................................. .............. IEC 60601-2-20 First edition Withdrawn. Transition
1990-12 Medical electrical period expired. See 6-
equipment--Part 2: Particular 299.
requirements for safety of
transport incubators.
6-146................................. .............. ANSI/AAMI/IEC 60601-2-21 First Withdrawn. Transition
edition 1994-02 and Amendment period expired. See 6-
1:2000 Medical electrical 227.
equipment--Part 2: Particular
requirements for safety of
infant radiant warmers.
6-182................................. .............. IEC 60601-2-38 First edition Withdrawn. Transition
1996-10 and Amendment 1:1999 period expired. See 6-
Medical electrical equipment-- 233.
Part 2-38: Particular
requirements for the safety
of electrically operated
hospital beds.
6-197................................. .............. IEC 60601-2-2 Ed. 1.0 Medical Withdrawn. Transition
electrical equipment--Part 2- period expired. See 6-
2: Particular requirements 228.
for the safety of high-
frequency surgical equipment.
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F. Neurology
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17-5.................................. .............. IEC 60601-2-10 First edition Withdrawn. Transition
1987, Amendment 1 2001-09 period expired. See 17-
Medical electrical equipment-- 11.
Part 2-10: Particular
requirements for the safety
of nerve and muscle
stimulators.
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G. OB-GYN/Gastroenterology
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9-4................................... .............. IEC 60601-2-16 Second edition Withdrawn. Transition
1998-02 Medical electrical period expired. See 9-
equipment--Part 2-16: 80.
Particular requirements for
the safety of haemodialysis,
haemodiafiltration, and
haemofiltration equipment.
9-42.................................. .............. IEC 60601-2-18 Second edition Withdrawn. Transition
1996-08, Amendment 1 2000-07 period expired. See 9-
Medical electrical equipment-- 61.
Part 2-18: Particular
requirements for the safety
of endoscopic equipment.
9-46.................................. .............. IEC 60601-2-2 Fourth edition Withdrawn. Transition
2006-07 Medical electrical period expired. See 9-
equipment--Part 2-2: 62.
Particular requirements for
the safety of high frequency
surgical equipment.
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H. Radiology
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12-34................................. .............. IEC 60601-2-7 Second edition Withdrawn. Transition
1998-02 Medical electrical period expired. See 12-
equipment--Part 2-7: 251.
Particular requirements for
the safety of high-voltage
generators of diagnostic x
ray generators.
[[Page 2456]]
12-54................................. .............. IEC 60601-2-8 Edition 1.1 1999- Withdrawn. Transition
04 Medical electrical period expired. See 12-
equipment--Part 2-8: 254.
Particular requirements for
the safety of therapeutic x
ray equipment operating in
the range 10 kilovolt (kV) to
1 millivolt (mV).
12-63................................. .............. IEC 60601-2-43 Edition 1.0 Withdrawn. Transition
2000-06 Medical electrical period expired. See 12-
equipment--Part 2-43: 202.
Particular requirements for
the safety of x ray equipment
for interventional procedures.
12-120................................ .............. IEC 60601-2-44 Edition 2.1 Withdrawn. Transition
2002-11 Medical electrical period expired. See 12-
equipment--Part 2-44: 256.
Particular requirements for
the safety of x ray equipment
for computed tomography.
12-126................................ .............. IEC 60601-2-28 First Edition Withdrawn. Transition
1.0 1993-03 Medical period expired. See 12-
electrical equipment--Part 2- 204.
28: Particular requirements
for the safety of x ray
source assemblies and x ray
tube assemblies for medical
diagnosis.
12-127................................ .............. 60601-2-32 First edition 1994- Withdrawn. Transition
03 Medical electrical period expired. See 12-
equipment--Part 2-32: 201.
Particular requirements for
the safety of associated
equipment of x ray equipment.
12-133................................ .............. IEC 60601-2-11 Second edition Withdrawn. Transition
1997-08, Amendment 1, 2004-07 period expired. See 12-
Medical electrical equipment-- 255.
Part 2-11: Particular
requirements for the safety
of gamma beam therapy
equipment.
12-147................................ .............. IEC 60601-2-5 Edition 2.0 2000- Withdrawn. Transition
07 Medical electrical period expired. See 12-
equipment--Part 2-5: 205.
Particular requirements for
the safety of ultrasonic
physiotherapy equipment.
12-152................................ .............. IEC 60601-2-1 Second edition Withdrawn. Transition
1998-06, Amendment 1 2002-05 period expired. See 12-
Medical electrical equipment-- 206.
Part 2-1: Particular
requirements for the safety
of electron accelerators in
the range 1 megaelectronvolts
(MeV) to 50 MeV.
12-178................................ .............. IEC 60601-2-45 Edition 2.0 Withdrawn. Transition
2001-05 Medical electrical period expired. See 12-
equipment--Part 2-45: 236.
Particular requirements for
the safety of mammographic x
ray equipment and
mammographic stereotactic
devices.
12-189................................ .............. IEC 60601-2-33 Edition 2.2 Withdrawn. Transition
2008-04 Medical electrical period expired. See 12-
equipment--Part 2-33: 207.
Particular requirements for
the safety of magnetic
resonance equipment for
medical diagnosis.
12-197................................ .............. IEC 60601-2-22 Second edition Withdrawn. Transition
1995-11 Medical electrical period expired. See 12-
equipment--Part 2-22: 208.
Particular requirements for
the safety of diagnostic and
therapeutic laser equipment.
12-198................................ .............. IEC 60601-2-37 First edition Withdrawn. Transition
2007-01, Amendment 1 2004-08, period expired. See 12-
Amendment 2 2005-11 Medical 209.
electrical equipment--Part 2-
37: Particular requirements
for the basic safety and
essential performance of
ultrasonic medical diagnostic
and monitoring equipment.
12-199................................ .............. IEC 60601-1-3 First edition Withdrawn. Transition
1994-07 Medical electrical period expired. See 12-
equipment--Part 1-3: General 210.
requirements for safety--3.
Collateral standard: General
requirements for radiation
protection in diagnostic x
ray equipment.
12-200................................ .............. IEC 60601-2-29 Second edition Withdrawn. Transition
1999-01 Medical electrical period expired. See 12-
equipment--Part 2-29: 211.
Particular requirements for
the safety of radiotherapy
simulators.
12-207................................ .............. IEC 60601-2-33 Edition 3.0 Transition period
2010-03, Medical electrical extended.
equipment--Part 2-33:
Particular requirements for
the basic safety and
essential performance of
magnetic resonance equipment
for medical diagnostic.
12-208................................ .............. IEC 60601-2-22 Third edition Transition period
2007-05 Medical electrical extended.
equipment--Part 2-22:
Particular requirements for
basic safety and essential
performance of surgical,
cosmetic, therapeutic, and
diagnostic laser equipment.
[[Page 2457]]
12-210................................ .............. IEC 60601-1-3 Edition 2.0 2008- Transition period
01 Medical electrical extended.
equipment--Part 1-3: General
requirements for basic safety
and essential performance--
Collateral standard:
Radiation protection in
diagnostic x ray equipment.
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\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In table 2 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: 033.
Table 2--New Entries to the List of Recognized Standards
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Reference No.
Recognition No. Title of standard \1\ and date
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A. General
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5-78.......................... Medical electrical ANSI/AAMI
equipment--Part 1: ES60601-1:2005/
General requirements (R)2012 and
for basic safety and C1:2009/(R)2012
essential performance and A2:2010/
(IEC 60601-1:2005, (R)2012
MOD). (Consolidated
Text).
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B. Radiology
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12-257........................ Medical electrical IEC 60601-2-44
equipment--Part 2-44: Edition 3.0
Particular 2009-02.
requirements for the
basic safety and
essential performance
of x ray equipment
for computed
tomography.
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12-268........................ Medical electrical IEC 60601-2-22
equipment--Part 2-22: Edition 3.1
Particular 2012-10.
requirements for
basic safety and
essential performance
of surgical,
cosmetic, therapeutic
and diagnostic laser
equipment.
12-269........................ Medical electrical IEC 60601-1-3
equipment--Part 1-3: Edition 2.1
General requirements 2013-04.
for basic safety and
essential
performance--Collater
al standard:
radiation protection
in diagnostic x ray
equipment.
12-271........................ Medical electrical IEC 60601-2-33
equipment--Part 2-33: Edition 3.1
Particular 2013-04.
requirements for the
basic safety and
essential performance
of magnetic resonance
equipment for medical
diagnosis.
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\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 our
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We 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. We 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 Number: 033, we will no longer be
announcing minor revisions to the list of recognized consensus
standards such as technical contact person, relevant guidance,
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 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 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 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: 033'' will be available on the CDRH home page.
You may access the
[[Page 2458]]
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 either electronic comments concerning
this document, or recommendations for additional standards for
recognition, by email to standards@cdrh.fda.gov or written comments to
the contact person (see FOR FURTHER INFORMATION CONTACT). 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. 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: 033. These modifications to the list of
recognized standards are effective upon publication of this notice in
the Federal Register.
Dated: January 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00477 Filed 1-13-14; 8:45 am]
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