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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/21/2017 Software/
Informatics
13-88 IEEE ISO 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
12/23/2016 Software/
Informatics
13-87 IEC ISO 15026-2 First edition 2011-02-15 Systems and software engineering - Systems and software assurance - Part 2: Assurance case
12/23/2016 Software/
Informatics
13-86 IEC ISO 15026-1 First edition 2013-11-01 Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary
12/23/2016 Software/
Informatics
13-85 CLSI AUTO11-A2 Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition
06/27/2016 Software/
Informatics
13-84 IEEE ISO 11073-10103 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
06/27/2016 Software/
Informatics
13-83 AAMI TIR57:2016 Principles for medical device security - Risk management.
06/27/2016 Software/
Informatics
13-82 AAMI ISO /TIR 80001-2-6:2014 Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
04/04/2016 Software/
Informatics
13-81 IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
04/04/2016 Software/
Informatics
13-80 IEEE Std 11073-20601:2014 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol [including Corrigendum 1 (2015)]
01/14/2019 Software/
Informatics
13-79 ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
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