Borrador del Comité
ISO/CD 11135
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Reference number
ISO/CD 11135
ISO/CD 11135
Edition 3
© ISO 2024
Borrador del Comité
Resumen
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
Informaciones generales
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Estado: En desarrolloEtapa: CD aprobado para su registro como DIS [30.99]
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Edición: 3
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Comité Técnico :ISO/TC 198ICS :11.080.01
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Ciclo de vida
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Anteriormente
PublicadoISO 11135:2014
PublicadoISO 11135:2014/Amd 1:2018
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Ahora
