New project
ISO/AWI 22442-3
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
Reference number
ISO/AWI 22442-3
Edition 2
© ISO 2024
New project
Under development
Drafting has started.
Will replace ISO 22442-3:2007

Abstract

ISO 22442-3:2007 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. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

General information

  • Status
     : Under development
    Stage
    : New project approved [10.99]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 194
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Life cycle

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