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DIN EN ISO 18969
Clinical evaluation of medical devices
DIN EN ISO 21762
Medical devices utilizing human tissues and their derivatives - Application of risk management
DIN SPEC 91509
Data model for the technical documentation of medical devices
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 10993-7/prA11
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
EN ISO 10993-12/prA1
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)
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)
EN ISO 10993-23/prA1
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1
EN ISO 14155/prA11
Clinical investigation of medical devices for human subjects - Good clinical practice