Standard Swedish standard · SS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

Status: Valid

· Amended by: SS-EN ISO 11135:2014/A1:2019

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Standard Swedish standard · SS-EN ISO 11135:2014

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Scope

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.

Subjects

Sterilization and disinfection in general (11.080.01)

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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

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