Standard

ISO 11135:2014

Published

Note: This standard has a draft: ISO/DIS 11135

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Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Edition: 2
  • Version: 1
  • Document type: IS
  • ICS 11.080.01
  • ISO TC ISO/TC 198

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