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AAMI/ISO TIR22442-4:2011/(R)2016
Medical devices utilizing animal tissues and their derivatives—Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
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Summary
Addresses methods of elimination and inactivation of transmissible spongiform encephalopathies (TSE agents) from animal tissues to be used in medical devices. The methods addressed will include those designed for: [1] inactivating infectivity (preferred method to reduce opportunities for cross-contamination); and [2] physically removing TSE agents (without complete inactivation). Includes inactivation and elimination methods to be used in the product manufacturing process and in facilities and equipment designed for utilizing animal tissue products. Annex 3
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2011 |
| Confirmation Date | 01/01/2016 |
| Page Count | 30 |
| Themes | Biological Evaluation |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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