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 info@document-center.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!
Thank you for this update Claudia. I will be interested to see when EN ISO 11135:2014 will replace EN ISO 11135-1:2007 as a European harmonised standard.
Hi Sam:
Nice to hear from you!
The document has already passed two CEN milestones — It was ratified on June 28th and made available to the various EU countries on July 16th. The next dates to watch for are the date of announcement, when the document needs to be publicized at the national level, on October 31 this year and the date of publication, which means that the national editions need to be issued by January 31st of next year.
Since this is a “popular” standard, we expect that the national editions should move through the process fairly quickly. However, as you know, each country has it’s own publication process, so the issue dates will vary across the continent.
Thanks again for asking!
Regards,
Claudia
Hi again!
Speaking of which… The BS EN ISO 11135 2014 Edition has been published, so the national adoptions are being issued even as we speak…
Regards,
Claudia
Dear Claudia:
Hello , I work wit these references , what is the difference between ISO 11135:2014 and USP 37, the EO levels are the same???
I appreciate if you send me the Limits Acceptance of EO for Medical Devices , surgical drapes, and surgical gowns.
waiting for your reply,
regards
Patricia
Hi Patricia:
And thank you so much for asking.
First, for EO (Ethylene Oxide) sterilization of surgical drapes and gowns, you’ll need ISO 10993-7. Another helpful document is the AAMI TIR19, which provides detail on the process. Both specifically address this issue, but they are copyright documents so you’ll need to purchase a copy. I’ll have staff get in touch with you about this.
Next, ISO 11135 does cover EO sterilization. So you may find it to be helpful as well.
Regarding the USP, this is the U.S. Pharmacopeia. Since this document covers standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements, there is a section on residue from EO. I do need to let you know that you’ll need to purchase the entire document to get just this section.
Lastly, there is a U.S. FDA guidance document back from 1993 that covers sterilization of surgical gowns and drapes. It is not an active guidance document, but is still available if you’ll like a copy. It would give you information on U.S. protocols.
Hope this is helpful!
Regards,
Claudia
We had an EO sterilization validation performed in fall of 2016, the report references that it is in accordance to 11135-1:2007. Is there a grace period that allows the use of :2007.
Hi Mary:
The ISO-11135-1 was withdrawn in 2014 in favor of the new ISO-11135 2nd Edition dated 7/1/2014.
Acceptable transition dates are always jurisdiction dependent. So you need to be sure that 1. you’re using an edition that is accepted in a specific jurisdiction, and 2. that you’re using the correct revision level. You’ll need to check in with the regulatory requirements for each place that you sell your product.
Having said that, there is the trend towards a 3-year transition period. So for the sake of best practices, you should certainly stop using the old standard by July of this year.
Any certification body that you use to audit your products can give you more specific and correct information than I can!
Best regards,
Claudia