FDA Releases 33 New Medical Device Standards

Posted 09 July 2014 By Alexander Gaffney, RAC

placeholder+image

US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards.

In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards.

Those standards come to be recognized by FDA through a process known as "incorporation by reference." Because the standards are often highly technical, time-consuming to produce and expensive to create, FDA defers to outside technical experts to create the standards, and then adopts those standards—sometimes with changes, but most often without—for use by regulated industry.

Members of industry are then responsible for complying with those standards, and usually must pay to access them.

So far this year, FDA has released three updates to the list of recognized standards:

Those updates have ranged from the minute, such as update 33's five new standards and 35's three new standards, but can also be massive, such as update 34's hundreds of changes and two dozen additions.

FDA's newest Recognition List, number 36, appears to be its largest yet this year, with 33 new standards and 153 changes to existing standards.

All newly-recognized standards may be found below. All other standards can be found in FDA's Federal Register notice.

Recognition No.Title of standardReference No. and date
A. Cardiovascular
3-127Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systemsANSI/AAMI/IEC 60601-2-47:2012.
3-128Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devicesANSI/AAMI/ISO 14117:2012.
B. General I (Quality System/Risk Management (QS/RM))
5-89Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: UsabilityIEC 60601-1-6 Edition 3.1 2013-10.
5-92Medical Electrical Equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsANSI/AAMI/IEC 60601-1-8:2006 & A1:2012.
C. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
19-1Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: electromagnetic compatibility—requirements and testsIEC 60601-1-2 Edition 3:2007-03.
19-2Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: electromagnetic compatibility—requirements and testsANSI/AAMI/IEC 60601-1-2:2007/(R)2012.
19-3Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral standard: requirements for the development of physiologic closed-loop controllersIEC 60601-1-10 Edition 1.0:2007-11.
19-4Medical 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 A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012.
19-5Medical 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).
19-6Medical 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)]IEC 60601-1-11 Edition 1.0:2010-04.
19-7Medical 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 (IEC 60601-1-11:2010 mod)ANSI/AAMI HA60601-1-11:2011.
19-8Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and testsIEC 60601-1-2 Edition 4.0:2014-02.
19-9Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllersIEC 60601-1-10 Edition 1.1:2013-11.
19-10Lithium batteriesUL 1642 5th Edition 2013.
19-11Household and commercial batteriesUL 2054 2nd Edition 2011.
D. Orthopedics
11-279Standard practice for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stemsASTM F2996-13.
11-280Standard test method for static, dynamic, and wear assessment of extra-discal single level spinal constructsASTM F2624-12.
E. Radiology
12-275Ultrasonics—Power measurement—Radiation force balances and performance requirementsIEC 61161 Edition 3.0:2013-01.
12-276Ultrasonics—Output test—Guide for the maintenance of ultrasound physiotherapy systemsIEC TS 62462 First edition 2007-05.
12-277Ultrasonics—Hydrophones—Part 1: Measurement and characterization of medical ultrasonic fields up to 40 megahertz (MHz)IEC 62127-1 Edition 1.1:2013-02.
12-278Ultrasonics—Hydrophones—Part 2: Calibration for ultrasonic fields up to 40 MHz (including corrigendum 1:2008 and amendment 1:2013)IEC 62127-2 Edition 1.0:2007-08.
12-279Ultrasonics—Hydrophones—Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHzIEC 62127-3 Edition 1.1:2013-05.
12-280Ultrasonics—Power measurement—High intensity therapeutic ultrasound (HITU) transducers and systemsIEC 62555 Edition 1.0:2013-11.
12-281Medical electrical equipment—Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipmentIEC 60601-2-62 Edition 1.0:2013-07.
12-282Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications—Part 1: Specification for productsISO 12609-1 First edition 2013-07-15.
12-283Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications—Part 2: Guidance for useISO 12609-2 First edition 2013-07-15.
F. Software/Informatics
13-67Health informatics—Personal health device communication—Part 10418: Device specialization—International normalized ratio (INR) monitorISO/IEEE 11073-10418 First edition 2014-03-01.
13-68Health informatics—Point-of-care medical device communication—Part 90101: Analytical instruments—Point-of-care testISO 11073-90101 First edition 2008-01-15.
13-69Health Informatics—Personal health device communication—Part 10472: Device specialization—Medication monitorISO/IEEE 11073-10472 First edition 2012-11-01.
G. Sterility
14-436Practice for dosimetry in radiation processingISO/ASTM 52628 First edition 2013-11-15.
14-437Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processingISO/ASTM 52701 First edition 2013-11-15.
14-450Biological indicators—Resistance performance testsUSP 37-NF32:2014 <55>.
14-451Biological indicators for sterilizationUSP 37-NF32:2014 <1035>.

Share this article:

Categories: Medical Devices, Manufacturing, News, US, CDRH

Tags: List of Recognized Standards, Medical Device Standards, Incorporation by Reference

Regulatory Exchange: Latest Updates From the Community