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
Edición 1
2007-12
International Standard
Vista previa
ISO 22442-3:2007
39351
No disponible en español
Publicado (Edición 1, 2007)
Esta norma se revisó y confirmó por última vez en 2022. Por lo tanto, esta versión es la actual.

ISO 22442-3:2007

ISO 22442-3:2007
39351
Idioma
Formato
CHF 129
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2007-12
    : Norma Internacional confirmada [90.93]
  •  : 1
     : 22
  • ISO/TC 194
    11.100.20 
  • RSS actualizaciones

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