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

OVERVIEW

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.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition 2014
No. of Pages 78
ICS Classification 11.080.01 Sterilization and disinfection in general
Committee ISO/TC 198
Available for Purchase For sale in Singapore only
Adoption ISO