CEN/TC 206
Registration number (WIID) | Project No. | Title | Status |
---|---|---|---|
78994 | EN ISO 10993-17:2023/prA1 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024) | Aptauja slēgta |
78993 | EN ISO 10993-23:2021/prA1 | Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAmd1:2024) | Izstrādē |
78992 | prEN ISO 10993-2 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024) | Izstrādē |
78991 | prEN ISO 10993-16 rev | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables | Izstrādē |
78989 | EN ISO 10993-12:2021/prA1 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024) | Izstrādē |
78988 | prEN ISO 10993-3 | Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025) | Aptauja |
78812 | prEN ISO 21762 | Medical devices utilizing human tissues and their derivatives -- Application of risk management | Izstrādē |
77939 | EN ISO 10993-4:2017/A1:2025 | Biological 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 |
77939 | LVS EN ISO 10993-4:2017/A1:2025 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025) | |
77933 | prEN ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025) | Aptauja |
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