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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
13-137 Complete IEEE Std 11073-10101b-2023 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
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
13-139 Complete IEEE Std 11073-10206-2022 Health informatics - Device interoperability - Part 10206: Personal health device communication - Abstract Content Information Model
05/29/2024 Sterility 14-598 Complete ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments - Part 3: Test methods
05/29/2024 Sterility 14-599 Complete ISO 14644-9 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
05/29/2024 Sterility 14-600 Complete ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
05/29/2024 Sterility 14-601 Complete ISO 17665 First edition 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/29/2024 Sterility 14-602 Complete AAMI TIR12:2020/(R)2023 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
05/29/2024 Sterility 14-603 Complete AAMI TIR28:2016/(R)2020 Product adoption and process equivalence for ethylene oxide sterilization
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