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REGULATION AND STANDARDS

Return to story: Revised Standards for Sterilisation: The Changes

Manufacturers are warned to check which version of the revised radiation sterilisation standard ISO 11137 Part 2 they are using. Many could be trying to comply with incorrect text. The confusion arose during the revision process of ISO 11137 Sterilisation of Health Care Products, Radiation. During ISO’s normal practice of editing the revised text, changes were made that introduced errors into the wording. This was not realised before several European Member States published the standard in April 2006 as EN ISO 11137:2006, Part 2.

ISO 11137-2:2006 was subsequently republished by ISO in August 2006. This corrected version bears the same title and year, but indicates August 2006 on its front page. CEN, the European standards body, required a formal route for issuing the corrected version of Part 2 and it will be publishing EN ISO 11137, 2:2007 (the August 2006 version of ISO 11137, 2:2006) in May 2007. CEN advises manufacturers to use this version for their compliance activities.

Information supplied by Arne Miller, Convenor CEN TC 204 WG 2.