| Theme | Regulatory status of ethylene oxide |
| Target Audience | Manufacturers, notified bodies |
| Products concerned | MD, IVD |
| Documents mentioned |
RDM (EU) 2017/745 RDIV (EU) 2017/746 Regulation (EU) No 528/2012 on biocidal products |
This guide deals with the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. This status was examined as part of the review programme provided for in Regulation (EU) No 528/2012 on biocidal products.
The guide specifies the status of :
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- EtO used for sterilisation during the manufacture of MDs and IVDs.
- EtO and associated sterilisation equipment used by healthcare establishments for sterilisation before the first use of MDs or after their use to allow them to be reused.
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