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U.S. Department of Health and Human Services

Recognized Consensus Standards

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08/06/2013 Software/
Informatics
13-55 IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/06/2013 Software/
Informatics
13-54 IEEE ISO 11073-10404 First edition 2010-05-01 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
08/06/2013 Software/
Informatics
13-53 IEEE ISO 11073-10415 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
08/06/2013 Software/
Informatics
13-52 IEEE ISO 11073-10408 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
08/06/2013 Software/
Informatics
13-49 IEEE ISO 11073-20101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
08/06/2013 Software/
Informatics
13-48 IEEE ISO 11073-10201 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 10201: Domain information model
08/06/2013 Software/
Informatics
13-47 IEEE ISO 11073-10101 First edition 2004-12-15 Health informatics - Point-of-care medical device communication - Part 10101: Nonmenclature
07/09/2014 Software/
Informatics
13-46 ASTM F2761-09 (2013) Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
08/06/2013 Software/
Informatics
13-44 ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
08/06/2013 Software/
Informatics
13-42 ANSI AAMI IEC TIR 80001-2-2:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
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