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Home>AAMI/ISO TI(R2244)2-4:2011/(R)2016

AAMI/ISO TI(R2244)2-4:2011/(R)2016

AAMI/ISO TI(R2244)2-4:2011/(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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This AAMI Technical Information Report (TIR) provides interpretive guidance for theapplication of ANSI/AAMI/ISO 11607-1997, Packaging for terminally sterilized medical devices. Also provided, in a special annex of this TIR , is a general review of the process of packaging validation.

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