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AAMI ANSI/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 transimissible spongiform encephalopathy (TSE) agents
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AAMI ANSI/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 transimissible spongiform encephalopathy (TSE) agents

PUBLISH DATE 2017
AAMI ANSI/AAMI/ISO 22442-3:2007/(R)2016
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.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 22442-3
Publication Date June 1, 2017
Language en - English
Page Count 36
Revision Level
Supercedes
Committee
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