Projects of NA 027-07-12 AA

ISO/DTS 25364-1 2024-11-14 Chemical characterization of medical devices - Part 1: Identification of organic extractables in Non-Targeted Analysis (NTA) 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 
ISO/DIS 10993-4 2024-10-29 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood More  Comment 
ISO/AWI 10993-13 2024-10-29 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More  Comment 
ISO/AWI 10993-14 2024-10-29 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More  Comment 
ISO/WD TR 21582 2024-10-29 Pyrogenicity - Principles and methods for pyrogen testing of 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 10993-16 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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