Revision of Standard – ISO 11135
ISO DIS 11135 - Draft Ethylene Oxide sterilization standard for medical devices available for comment
For anyone that works in the medical device sector, the following standard is key to demonstrating ethylene oxide sterilization processes are validated and controlled thereby ensuring the sterility of the final product:
ISO DIS 11135 – Sterilization of health-care products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
A revision of this standard is currently underway, and the draft is available for public consultation on the NSAI Draft standard portal, Your Standard Your Say (YSYS)
The draft standard can be accessed and reviewed from this platform – see link here.
Comments on the draft can also be submitted on the platform.
The draft standard is available on YSYS until 20th of August 2025.
To access the draft national stakeholders can register and set up an account or log in if they already have an account – see link here.
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