ISO 11135:2014
Sterilization of health care products — Ethylene oxide
Requirements for ethylene oxide sterilization
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class IIa medical device, Class IIb medical device, Class III medical device
In practice
For sterile devices. Process validation: installation qualification, performance qualification, routine protocol. Cycle documentation is required.
Official sources
https://www.iso.org/standard/56137.htmlSee where this text lands in your roadmap
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