CEN/TC 206

Registration number (WIID)Project No.TitleStatus
78989LVS EN ISO 10993-12:2021/A1:2025Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025) 
78993LVS EN ISO 10993-23:2021/A1:2025Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025) 
75596LVS EN ISO 10993-1:2025Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025) 
78994LVS EN ISO 10993-17:2023/A1:2025Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025) 
78989EN ISO 10993-12:2021/A1:2025Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)Standarts spēkā
60725LVS EN ISO 10993-18:2020Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)Standarts spēkā
65480LVS EN ISO 22442-1:2021Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)Standarts spēkā
62983LVS EN ISO 14155:2020Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)Standarts spēkā
32000LVS EN ISO 10993-14:2009Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)Standarts spēkā
9493LVS EN ISO 10993-7:2009Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)Standarts spēkā
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