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AAMI/ISO 22442-3:2007/(R)2016

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 01/25/2008

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Full Description

Specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. Does not cover other transmissible and non-transmissible agents.
 

Product Details

Published:
01/25/2008
ANSI:
ANSI Approved
Number of Pages:
36
File Size:
1 file , 280 KB
Note:
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