Last Thursday I promised you more information on new medical device sterilization standards, so here we go… The New ISO 11135 2nd Edition is here! This new release, titled “Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices,” replaces the ISO 11135-1 and the ISO 11135-2, both of which are now obsolete. The new edition is available from Document Center Inc. in both paper format and for pdf download. You can even include it in your Standards Online subscription service!
ISO 11135 provides a methodology for setting up and validating an EO (ethylene oxide) sterilization process for medical devices. It can be used in both manufacturing and heath care facility settings. It provides you with guidance on how to sterilize — other standards like EN 556-1 and AAMI ST67 tell you what degree of sterilization you’ll need to achieve. The new AAMI TIR56 covers EO Sterilization for flexible packaging which is not included in the ISO 11135. And the requirements for sterilizing to inactivate spongiform encephalogathy agents (Creutzfeldt-Jakob disease, etc.) are specifically excluded.
Since this new 2nd Edition represents the consolidation of the Parts 1 and 2, it is a complete overhaul of the document. The basic structure of the core standard is stable, with the information being presented in 12 clauses. However, you’ll see the changes immediately in the way information is included in the Annexes.
Let’s take a look at them. FYI: Annexes A and B are part of the requirements of the document, C through E are informative only.
- Annex A – Determination of lethal rate of the sterilization process — Biological indicator/bioburden approach
- Annex B – Conservative determination of lethal rate of the sterilization process — Overkill approach
- Annex C – Temperature sensors, RH sensors and biological indicator numbers
- Annex D – Guidance on the application of the normative requirements
- Annex E – Single Lot Release
The document ends with a 43-item bibliography. And although the document is 88 pages long, only 78 of those pages contain technical content.
Of course, you’re going to need a copy of this new update and you’ll get your copy from Document Center Inc. You have the option of using our webstore at www.document-center.com or working with our staff (phone 650-591-7600, fax 650-591-7617, or email email@example.com). You’ll be able to choose to purchase a paper copy or request a pdf download. You can even get our Standards Online annual subscription access service for this document.
And you’ll be able to be confident that whenever any modifications or updates for the ISO 11135 are issued, you’ll be notified. We’ve been working with customers like you since 1982. Make Document Center you’re Standards Experts!