ISO 22442-3:2007 Preview

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

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
  • Edition : 1
    Number of pages : 22
  • :
    ISO/TC 194/SC 1
    Tissue product safety
  • 11.100.20
    Biological evaluation of medical devices

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    ISO 22442-3:2007

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