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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Date of
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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
08/14/2015 Software/
Informatics
13-78 IEC ISO 30111 First edition 2013-11-01 Information technology - Security techniques - Vulnerability handling processes
08/14/2015 Software/
Informatics
13-77 IEC ISO 29147 First edition 2014-02-15 Information technology - Security techniques - Vulnerability disclosure
08/14/2015 Software/
Informatics
13-76 ISO 11073-91064 First edition 2009-05-01 Health informatics - Standard communication protocol - Computer-assisted electrocardiography
08/14/2015 Software/
Informatics
13-75 IEEE ISO 11073-10102 First edition 2014-03-01 Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015 Software/
Informatics
13-74 IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/14/2015 Software/
Informatics
13-73 IHTSDO SNOMED-CT RF2 Release 2015 Systematized Nomenclature of Medicine - Clinical Terms
01/27/2015 Software/
Informatics
13-72 IEEE Std 11073-10425-2014 Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
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