CSA Z11135-1
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
| Organization: | CSA |
| Publication Date: | 1 January 2009 |
| Status: | active |
| Page Count: | 60 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
Preface
This is the first edition of CAN/CSA-Z11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 11135-1 (first edition, 2007-05-01). This Standard replaces CAN/CSA-ISO 11135-98, Medical devices - Validation and routine control of ethylene oxide sterilization (adopted ISO 11135:1994).
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
Document History
