AAMI 22442-3:2007 (R2016) PDF Download
Standard EN Sample
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
Also Known As: ANSI/AAMI/ISO 22442-3:2007 (R2016)
SKU144681542
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2008-01-25
Pages CountPages36
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.
Details
| Language(s) | English |
| File Size | 962.6 KB |
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