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DIN EN ISO 18969
Clinical evaluation of medical devices
DIN EN ISO 20417 rev
Medical devices - Information to be supplied by the manufacturer
EN ISO 10993-4/prA1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
EN ISO 10993-17/prA1
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1
FprEN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices
ISO/AWI 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 cleaning classification.
NA 027-05 FB
Section Invasive Medical Devices
NA 027-06 FB
Section Non-invasive Medical Devices
NA 027-07 FB
Section Biological and Clinical Evaluation of Medical Devices
ISO/TC 210/JWG 2
Joint ISO/TC 210-IEC/SC 62A WG : Medical device software
