International Standard
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
Reference number
ISO 22442-3:2007
Edition 1
2007-12
© ISO 2024
International Standard
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Published (Edition 1, 2007)
This standard was last reviewed and confirmed in 2022. Therefore this version remains current.

ISO 22442-3:2007

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CHF 129
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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
     : Published
    Publication date
     : 2007-12
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 22
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
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