ISO/TC 194
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 90746 | ISO/AWI 22442-3 | 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 | Izstrādē |
| 90930 | ISO/CD TS 25364-1 | Chemical Characterization of Medical Devices — Part 1: Identification of Organic Extractables in Non-Targeted Analysis (NTA) | Izstrādē |
| 90931 | ISO/CD TS 25364-2 | Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA) | Izstrādē |
| 90932 | ISO/CD TS 25364-3 | Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for evaluating organic medical device extractables and leachables via Non-Targeted Analysis (NTA) | Izstrādē |
| 91188 | ISO/AWI 25695 | Medical devices utilizing bioengineered biological substances — Application of risk management | Izstrādē |
| 91724 | ISO/AWI TS 25364-4 | Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA) | Izstrādē |
| 92777 | ISO/AWI TS 26177 | Biological evaluation of medical devices – Guidance on risk estimation in the application of ISO 10993-1” | Izstrādē |
| 93382 | ISO/PWI TR 26376 | Biological evaluation of medical devices – Information on biological equivalence in the application of ISO 10993-1 | Izstrādē |
| 93383 | ISO/PWI TR 26397 | Biological evaluation of medical devices – Information on reasonably foreseeable misuse in the application of ISO 10993-1 | Izstrādē |
| 93384 | ISO/PWI TR 26398 | Biological evaluation of medical devices - Information on the use of clinical data in the application of ISO 10993-1 | Izstrādē |
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