Standard

ISO 22442-3:2007

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Zusammenfassung

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.

Produktspezifikationen

  • Standard von ISO
  • Ausgabedatum:
  • Edition: 1
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: ISO
  • Lieferant: ISO
  • ICS: 11.100.20
  • Internationales Komitee: ISO/TC 194

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