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FprEN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: requirements for aseptically processed medical devices
DIN EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
prEN ISO 10993-1
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
DIN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
prEN ISO 18969
Clinical evaluation of medical devices
DIN EN ISO 18969
Clinical evaluation of medical devices
DIN EN ISO 10993-4/A1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
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)
DIN EN ISO 10993-17/A1
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024
EN ISO 10993-17/prA
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-14:2023/DAmd 1:2024)
