Developments in ETO Sterilization Standards

Revision to ISO11135 will require customers using the Andersen flexible chamber system to validate in line with ISO14937.

Doubilet Drain

The revision to ISO11135 will shortly be issued as an FDIS version, the final stage before issue. This incorporates and updates content from both ISO11135 Part 1 and Part 2, and replaces both parts. Andersen Products attends both the relevant CEN and ISO working groups (CEN TC102 WG4 and ISO TC198 WG1); speaking as representatives of NBN, the Belgian national standards body.

This revision contains many changes and will, for the first time, specifically exclude flexible chamber systems. Andersen has proposed an extended transition time, up from 6 months to 36 months which is being formally supported by CEN. This will allow manufacturers using flexible chamber systems currently audited in line with ISO11135 to change to being audited in line with ISO14937. The extended transition will also allow manufacturers who will continue to be audited against ISO11135 time to understand and implement the many changes being introduced in this revision.

 Those applying ISO14937 in future to their flexible chamber systems will do so under the third application listed in the introduction to that standard: - as a framework for the preparation or revision of standards for specific sterilization processes.

 A Technical Specification has been proposed, that will guide users as to how ISO14937 should be used when applied to flexible chamber EtO sterilization systems.