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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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 11135:2014
Document Year: 2014
Pages: 78
Edition: 2
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

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ISO 11135:2014
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