Nuevo proyecto
ISO/AWI 22442-3
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/AWI 22442-3
ISO/AWI 22442-3
Edition 2
© ISO 2024
Nuevo proyecto
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: En desarrolloEtapa: Nuevo proyecto aprobado [10.99]
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Edición: 2
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Comité Técnico :ISO/TC 194
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Ciclo de vida
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Anteriormente
PublicadoISO 22442-3:2007
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Ahora