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ANSI/AAMI/ISO TIR22442-4:2011 (R2016)
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.
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.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]