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U.S. Department of Health and Human Services

Recognized Consensus Standards

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12/04/2017 Software/
Informatics
13-98 IEC ISO 646 Third edition 1991-12-15 Information technology - IS0 7-bit coded character set for information interchange
INCITS ISO IEC 646:1991[R2013] Information technology - IS0 7-bit coded character set for information interchange
08/21/2017 Software/
Informatics
13-97 IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
08/21/2017 Software/
Informatics
13-96 ANSI UL 2900-1 First Edition 2017 Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements
08/21/2017 Software/
Informatics
13-95 IEEE ISO 11073-10425 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)
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)
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