Draft
International StandardISO/DIS 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/DIS 11135
ISO/DIS 11135
Edition 3
© ISO 2025
Proyecto Norma internacional
ISO/DIS 11135
90088
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Reemplazará ISO 11135:2014
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: DIS registrado [40.00]
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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
