What is this standard about?
This standard details how to develop, validate and reliably reproduce an ethylene oxide sterilization process for medical devices that has appropriate microbicidal activity. In particular, this edition of the standard introduces amendments that clarify Annex E on single batch release.
Who is this standard for?
- Medical devices manufacturers, specifically those producing small lots/clinical trial samples
- Healthcare regulatory bodies
Why should you use this standard?
Because it describes requirements that, if met, will provide an ethylene oxide sterilization process with appropriate microbicidal activity intended to sterilize medical devices. It addresses the need for quality systems, staff training and proper safety measures.
In particular, the amendment supplies a revised version of Annex E. This provides a clear, practical approach to performing a simplified validation method for small lots such as those produced as clinical trial samples.
What’s changed since the last update?
The existing Annex E was unclear and ambiguous, leading to its misuse. It has been amended to:
- Clarify when the method should be applied: i.e. for research and development of new product or for clinical trial product
- Clarify that data resulting from a single batch release study can be used to support a full validation study
- Clarify that temperature and relative humidity sensors should be used to establish conditions in the sterilization load during both the half cycle and the full cycle comprising a single batch release
As well, the European Foreword and Annex Zs have been updated into the latest format and expectations to a level of detail which should help the listing of the standard in the Official Journal and the formal harmonization of the latest edition (New Medical Devices Regulation).