CEN/TC 206
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
60722 | EN ISO 10993-9:2021 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) | Standarts spēkā |
37559 | EN ISO 14155:2011 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) | Atcelts |
37236 | EN ISO 14155:2011/AC:2011 | Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011) | Atcelts |
62983 | EN ISO 14155:2020 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) | Standarts spēkā |
79539 | EN ISO 14155:2020/A11:2024 | Clinical investigation of medical devices for human subjects - Good clinical practice | Standarts spēkā |
60213 | EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) | Atcelts |
65480 | EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) | Standarts spēkā |
60214 | EN ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015) | Atcelts |
65481 | EN ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020) | Standarts spēkā |
25795 | EN ISO 22442-3:2007 | Medical 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 |
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