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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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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
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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