ISO 22442-3:2007
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ISO 22442-3:2007
39351

Abstract  Preview

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 

  •  :  Published
     : 2007-12
  •  : 1
     : 22
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :
    11.100.20 Biological evaluation of medical devices

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std 1 118 PDF
std 2 118 Paper
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