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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/21/2017 Software/
Informatics
13-94 IEEE ISO 11073-10424 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/21/2017 Software/
Informatics
13-93 IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
08/21/2017 Software/
Informatics
13-92 IEEE ISO 11073-10421 First edition 2012-11-01 Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/21/2017 Software/
Informatics
13-91 IEEE ISO 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
08/21/2017 Software/
Informatics
13-90 IEEE Std 11073-10417-2015 Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
08/21/2017 Software/
Informatics
13-89 IEEE ISO 11073-10406 First edition 2012-12-01 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
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
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