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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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05/26/2025 Software/
Informatics
13-143 Complete AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software
05/26/2025 Software/
Informatics
13-142 Complete FIRST CVSS v3.1 Common Vulnerability Scoring System version 3.1
12/23/2024 Software/
Informatics
13-141 Complete ISO IEEE 11073-10701 First Edition, 2024-09 Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System
IEEE Std 11073-10701-2022 Health informatics - Device interoperability Part 10701: Point-of-care medical device communication - Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system
05/25/2026 Software/
Informatics
13-140 Complete FIRST CVSS v4.0 Common Vulnerability Scoring System version 4.0
05/29/2024 Software/
Informatics
13-139 Complete ISO IEEE 11073-10206:2024 Health informatics - Device interoperability Part 10206: Personal health device communication - Abstract content information model
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 ISO IEEE 11073-10700 First Edition 2024-09 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
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
ISO IEEE 11073-20601-2019 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
IEEE Std 11073-10407-2020 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
IEEE Std 11073-10404-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
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