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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
DIN EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
DIN EN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German version FprEN 556-2:2024
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
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
DIN EN ISO 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
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
DIN EN ISO 12417-1
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
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