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Posted 13 January 2014 | By Alexander Gaffney, RAC,
The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulator, has announced that it plans to recognize five new standards maintained by outside groups and intended for medical electrical equipment.
Standards for the proper manufacture of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.
The process, known as Incorporation by Reference, involves FDA formally recognizing those standards in the Federal Register, which it does several times each year.
The latest set of references listed in the Federal Register by FDA includes a list of 41 standards that are set to be retired, generally because they were succeeded by newer versions of the same standard.
But in addition to the 41 outgoing standards, FDA's Federal Register announcement also includes five new medical electrical equipment standards set to be recognized by FDA as being appropriate for use in their respective settings:
Recognition No.
Title of Standard
Reference Number and Date
5-78
Medical electrical equipment--Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
ANSI/AAMI ES60601-
1:2005/(R)2012 and
C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text)
12-257
Medical electrical equipment--Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44 Edition
3.0 2009-02
12-268
Medical electrical equipment--Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-22 Edition
3.1 2012-10
12-269
Medical electrical equipment--Part 1-3: General requirements for basic safety and essential performance--Collateral standard: radiation protection in diagnostic X-ray equipment
IEC 60601-1-3 Edition 2.1
2013-04
12-271
Medical electrical equipment--Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33 Edition
3.1 2013-04
A full list of all recognized standards maintained by FDA may be found on its website, here.
Federal Register notice
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