Projects of CEN/TC 206

DIN EN ISO 22442-2 rev 2026-08-18 Medical devices utilizing tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More  Comment 
DIN EN ISO 22442-1 rev 2026-08-18 Medical devices utilizing tissues and their derivatives - Part 1: Application of risk management More  Comment 
DIN EN ISO 14155 rev 2026-06-29 Clinical investigation of medical devices for human subjects - Good clinical practice More  Comment 
DIN EN ISO 22442-3 rev 2024-11-11 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 More  Comment 
DIN EN ISO 10993-4 2024-11-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO/DIS 10993-4:2026); German and English version prEN ISO 10993-4:2026 More  Comment 
DIN EN ISO 10993-14 rev 2024-11-04 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More  Comment 
DIN EN ISO 10993-13 rev 2024-11-04 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More  Comment 
DIN EN ISO 10993-2 2023-11-14 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024); German and English version prEN ISO 10993-2:2024 More  Comment 
DIN EN ISO 10993-3 2023-11-14 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/FDIS 10993-3:2026); German version FprEN ISO 10993-3:2026 More  Comment 
DIN EN ISO 10993-16 2023-11-14 Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025); German and English version prEN ISO 10993-16:2025 More  Comment 

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