This standard was last reviewed and confirmed in 2020. Therefore this version remains current.
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.
Status: PublishedPublication date: 2014-07
Edition: 2Number of pages: 78
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
This standard contributes to the following Sustainable Development Goal:
Buy this standard
|std 1 187|
|std 2 187||Paper|
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsPublished
ISO 11135:2014/Amd 1:2018
Will be replaced byUnder development
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