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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
01/30/2014 Sterility 14-336 Partial ISO 14161 Second edition 2009-09-15 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ANSI AAMI ISO 14161-2009/(R)2014 Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
01/30/2014 Sterility 14-334 Partial ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
04/04/2016 Sterility 14-333 Complete ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
03/16/2012 Sterility 14-332 Complete ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ANSI AAMI ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
09/17/2018 Sterility 14-294 Complete ANSI AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
09/17/2018 Sterility 14-293 Complete ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
07/09/2014 Sterility 14-290 Complete ANSI AAMI ST24:1999/(R)2018 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
07/09/2014 Sterility 14-286 Complete ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
07/09/2014 Sterility 14-282 Complete ASTM F2338-09 (Reapproved 2020) Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
04/04/2016 Sterility 14-277 Complete ANSI AAMI ISO TIR 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
ISO TS 17665-2 First edition 2009-01-15 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
07/09/2014 Sterility 14-257 Complete ASTM D3078-02 (Reapproved 2021)e1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
07/09/2014 Sterility 14-256 Complete ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
01/27/2015 Sterility 14-243 Complete ISO 14644-6 First edition 2007-07-15 Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015 Sterility 14-242 Complete ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
09/09/2008 Sterility 14-240 Complete ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
09/09/2008 Sterility 14-239 Complete ISO 13408-3 First edition 2006-09-15 Aseptic processing of health care products - Part 3: Lyophilization
ANSI AAMI ISO 13408-3:2006/(R)2015 Aseptic processing of health care products - Part 3: Lyophilization
01/15/2013 Sterility 14-217 Complete AOAC 6.3.02:2006 Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
01/15/2013 Sterility 14-215 Complete AOAC 6.2.05:2006 Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013 Sterility 14-213 Complete AOAC 6.2.03:2006 Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
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
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
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
05/29/2024 Software/
Informatics		 13-139 Complete IEEE Std 11073-10206-2022 Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
05/29/2024 Software/
Informatics		 13-138 Complete IEEE Std 11073-10700-2022 Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System
05/29/2024 Software/
Informatics		 13-137 Complete IEEE Std 11073-10101b-2023 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
05/29/2024 Software/
Informatics		 13-136 Complete ISO IEEE 11073-20601 Third Edition 2022-12 Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol
05/29/2024 Software/
Informatics		 13-135 Complete ISO IEEE 11073-10407 Second edition 2022-12 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
05/29/2024 Software/
Informatics		 13-133 Complete ISO IEEE 11073-10415 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
05/29/2024 Software/
Informatics		 13-132 Complete ISO IEEE 11073-10408 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
10/09/2023 Software/
Informatics		 13-131 Complete ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
10/09/2023 Software/
Informatics		 13-130 Complete ANSI AAMI 2700-2-1:2022 Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging
10/09/2023 Software/
Informatics		 13-129 Complete ISO IEC IEEE 29119-1 Second edition 2022-01 Software and systems engineering - Software testing - Part 1: General concepts
12/19/2022 Software/
Informatics		 13-128 Complete IEEE UL Std 2621.2-2022 Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 Software/
Informatics		 13-125 Complete ANSI AAMI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
12/19/2022 Software/
Informatics		 13-124 Complete AAMI CR34971:2022 Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
12/20/2021 Software/
Informatics		 13-120 Complete ANSI AAMI 2700-1:2019 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
06/07/2021 Software/
Informatics		 13-119 Complete ANSI ISA 62443-4-1-2018 Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements.
06/07/2021 Software/
Informatics		 13-118 Complete IEEE Std 11073-40102:2020 Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation.
 
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