scope:

Preface

This is the first edition of CSA Standard CANKSA-IS0 11 135, Medicaldevices - Validation and routine confrol of ethylene oxide sterilization, which is an adoption without modification of the identically titled IS0 (International Organization for Standardization) Standard 11 135:1994 (first edition, 1994-02-01). It supersedes CSA Standard CAN/CSA-Z314.5-88, Industrial Sterilization of Medical Devices by the Ethylene Oxide Process.

This Standard is intended to provide guidance for companies in determining minimum requirements for a program of sterility assurance. It is directed towards all firms that sterilize their own products, perform "contract" sterilization, or manufacture a device to be sterilized by another firm. This Standard is not intended to apply to validation and routine control of sterilization in hospitals or other health care facilities.

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. A list of the members of these Committees is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.