Projects of NA 027-05-10 AA

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 
ISO/AWI 22442-1 2026-08-13 Medical devices utilizing tissues and their derivatives - Part 1: Application of risk management More  Comment 
ISO/AWI 22442-2 2026-08-13 Medical devices utilizing tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More  Comment 
ISO 6631 AMD 1 2026-07-15 Tissue-engineered medical products - Quantification of bovine type I collagen marker peptide with liquid chromatography - Tandem mass spectrometry - Amendment 1 More  Comment 
ISO/CD 25695 2025-04-04 Medical devices utilizing bioengineered biological substances - Application of risk management 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 
ISO/AWI 22442-3 2024-10-29 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 21762 2023-10-19 Medical devices utilizing non-viable human materials - Risk management (ISO/FDIS 21762:2026); German and English version FprEN ISO 21762:2026 More  Comment 
ISO/FDIS 21762 2023-07-24 Medical devices utilizing non-viable human materials - Application of risk management More  Comment 

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