Medical devices utilizing animal tissues and their derivatives - Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes Ingestion-build-79769 continuously hot-dip coated flat products

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Medical devices utilizing animal tissues and their derivatives - Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes Ingestion-build-79769 continuously hot-dip coated flat products1 Scope This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs). The TSE removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non viable