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
ISO 22442-3:2007
Edición 1
2007-12
2007-12
© ISO 2024
International Standard
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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.
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
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Estado: PublicadoFecha de publicación: 2007-12Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 22
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Comité Técnico :ISO/TC 194ICS :11.100.20
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