ANSI/AAMI/ISO 22442-3:2007
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 No.

ANSI/AAMI/ISO 22442-3:2007

Release Date

2008

Published By

American National Standards Institute （ANSI)

Latest

ANSI/AAMI/ISO 22442-3:2007

Scope

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.

ANSI/AAMI/ISO 22442-3:2007 history

• 2008 ANSI/AAMI/ISO 22442-3:2007 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