Projects of NA 027-07-12 AA

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 
ISO/CD TR 24850 2023-10-31 Sources of hazard information for medical device constituents More  Comment 
ISO/DIS 10993-2 2023-10-27 Biological evaluation of medical devices - Part 2: Animal welfare requirements More  Comment 
ISO/DIS 10993-16 2023-10-27 Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables More  Comment 
ISO 10993-3 2023-10-27 Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity More  Comment 
DIN EN ISO 10993-11 2023-04-25 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2026); German and English version prEN ISO 10993-11:2026 More  Comment 
ISO/DIS 10993-11 2023-04-18 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More  Comment 
DIN EN ISO 10993-6 2023-01-27 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2026); German version EN ISO 10993-6:2026 More  Comment 
DIN EN ISO 10993-7 2022-03-29 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026); German version EN ISO 10993-7:2026 More  Comment 

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