International Standard
ISO 13408-5:2006
Aseptic processing of health care products — Part 5: Sterilization in place
Reference number
ISO 13408-5:2006
ISO 13408-5:2006
Edición 1
2006-11
2006-11
© ISO 2024
International Standard
p
ISO 13408-5:2006
35290
No disponible en español
Publicado
(Edición 1, 2006)
Esta norma se revisó y confirmó por última vez en 2021.
Por lo tanto, esta versión es la actual.
Resumen
ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2006-11Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 14
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Comité Técnico :ISO/TC 198ICS :11.080.01
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