SR 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)

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.

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General information

Status : Valid
Approval date : 12/23/2014
Number of pages : 84
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11135-1:2007
Normative reference SR EN ISO 11138-2:2009
Normative reference SR EN ISO 13485:2012/AC:2012
Normative reference SR EN ISO 10993-7:2009/AC:2010
Normative reference SR EN ISO 11737-1:2006/AC:2009
Normative reference SR EN ISO 11737-2:2010
Normative reference SR EN ISO 10993-7:2009
Normative reference SR EN ISO 11140-1:2015
Normative reference SR EN ISO 11138-1:2007
Normative reference SR EN ISO 13485:2012
Normative reference SR EN ISO 11737-1:2006
Normative reference SR EN ISO 10012:2004
Amended by SR EN ISO 11135:2014/A1:2020