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DIN EN IEC 63521
Machine learning-enabled medical device - Performance evaluation process
prCEN ISO/TS 17664-3
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification
FprEN ISO 20417
Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2025)
DIN EN ISO 20417
Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2025); German version FprEN ISO 20417:2025
DIN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/FDIS 14155:2025); German version FprEN ISO 14155:2025
DIN CEN ISO/TS 17664-3
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a quantitative cleaning classification
ISO/DTS 17664-3
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a cleaning classification
EN ISO 14937/prA1
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 - Amendment 1
DIN EN ISO 14937/A1
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 - Amendment 1