CEN/TC 206

Registration number (WIID)Project No.TitleStatus
65727LVS EN ISO 10993-4:2018Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)Standarts spēkā
75885EN ISO 10993-7:2026Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)Standarts spēkā
64034LVS EN ISO 10993-7:2009/A1:2022Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)Standarts spēkā
74131LVS EN ISO 10993-18:2020/A1:2023Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)Standarts spēkā
65481LVS EN ISO 22442-2:2021Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)Standarts spēkā
79539LVS EN ISO 14155:2020/A11:2024Clinical investigation of medical devices for human subjects - Good clinical practiceStandarts spēkā
80820LVS EN ISO 10993-5:2009/A11:2025Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityStandarts spēkā
77939LVS EN ISO 10993-4:2017/A1:2025Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)Standarts spēkā
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)Standarts spēkā
68925LVS EN ISO 10993-23:2021Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)Standarts spēkā
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