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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
08/21/2017 Software/
Informatics		 13-67 Complete ISO IEEE 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
07/09/2014 Software/
Informatics		 13-65 Complete UL ANSI 1998 Third Edition 2013 Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
01/30/2014 Software/
Informatics		 13-63 Complete ANSI AAMI IEC TIR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
IEC TR 80001-2-4 Edition 1.0 2012-11 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
08/06/2013 Software/
Informatics		 13-61 Complete IEC 62443-2-1 Edition 1.0 2010-11 Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
08/06/2013 Software/
Informatics		 13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013 Software/
Informatics		 13-59 Complete ISO IEC IEEE 15026-4 First edition 2021-10-01 Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
08/06/2013 Software/
Informatics		 13-57 Complete ISO IEEE 11073-10407 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
08/06/2013 Software/
Informatics		 13-56 Complete IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/06/2013 Software/
Informatics		 13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
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