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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
01/15/2013 Sterility 14-212 Complete AOAC 6.2.02:2006 Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
09/09/2008 Sterility 14-191 Complete ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
01/27/2015 Sterility 14-165 Complete ISO 14644-5 First edition 2004-08-15 Cleanrooms and associated controlled environments - Part 5: Operations
09/09/2008 Sterility 14-142 Complete ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
05/25/2026 Software/
Informatics
13-158 Complete IEEE Std 1752.1-2021 Open Mobile Health Data: Representation of Metadata, Sleep, and Physical Activity Measures
05/25/2026 Software/
Informatics
13-157 Complete IEEE Std 11073-10207-2017 [Including Cor 1-2025] Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)]
12/22/2025 Software/
Informatics
13-156 Complete ISO IEEE 11073-10471 Second Edition 2024-09 Health Informatics - Device Interoperability - Part 10471: Personal Health Device Communication - Device Specialization-Independent Living Activity Hub
IEEE Std 11073-10471-2023 Health Informatics - Device interoperability - Part 10471: Personal health device communication - Device specialization - Independent living activity hub
12/22/2025 Software/
Informatics
13-155 Complete IEEE Std 11073-10442-2023 Health informatics - Device Interoperability Part 10442: Personal health device communication - Device specialization - Strength fitness equipment
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