Standard

ISO 22442-3:2007

Current

Existing or new amendments and versions must be purchased separately.

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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.

Products specifications

  • Standard from ISO
  • Published:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: ISO
  • Distributor: ISO
  • ICS: 11.100.20
  • International TC: ISO/TC 194

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