CEN/TC 206

Registration number (WIID)Project No.TitleStatus
30398EN ISO 10993-3:2014Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011)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
65481EN ISO 22442-2:2020Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018)Standarts spēkā
27051LVS EN ISO 10993-13:2010Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)Standarts spēkā
62983LVS EN ISO 14155:2020Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)Standarts spēkā
25795EN ISO 22442-3:2007Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)Standarts spēkā
80820EN ISO 10993-5:2009/A11:2025Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityStandarts spēkā
22089EN ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO/FDIS 10993-5:2009)Standarts spēkā
78993EN 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)Standarts spēkā
79539LVS EN ISO 14155:2020/A11:2024Clinical investigation of medical devices for human subjects - Good clinical practiceStandarts spēkā
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