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ISO/TC 215/JWG 7
Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices
prCEN ISO/TS 24971-2
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence
DIN CEN ISO/TS 24971-2
Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence
DIN EN ISO 15883-2
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/FDIS 15883-2:2024); German and English version FprEN ISO 15883-2:2024
DIN EN ISO 15223-1/ A1
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1 (ISO 15223-1:2021/DAM 1:2024); German and English version EN ISO 15223-1:2021/prA1:2024
EN ISO 15223-1/prA1
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/DAM 1:2024)
DIN EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023
prEN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
DIN EN ISO 20417 rev
Medical devices - Information to be supplied by the manufacturer
prEN ISO 20417 rev
Medical devices - Information to be supplied by the manufacturer
