Reference number
ISO 13408-7:2012
ISO 13408-7:2012
© ISO 2024
International Standard
ISO 13408-7:2012
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
Edition 1
2012-08
2012-08
ISO 13408-7:2012
30061
Publicado
(Edición 1, 2012)
Esta publicación se revisó y confirmó por última vez en 2023.
Por lo tanto, esta versión es la actual.
Resumen
ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2012-08Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 19
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Comité Técnico :ISO/TC 198ICS :11.080.01
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