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Article R6111-19 of the French Public Health Code

Sterilisation is the set of operations used to obtain the sterile state of a medical device and to maintain this state.

The activity of sterilising medical devices is subject to the granting of an authorisation mentioned in 10° of article R. 5126-9.

Original in French 🇫🇷
Article R6111-19

La stérilisation est l’ensemble des opérations permettant d’obtenir l’état de stérilité d’un dispositif médical ainsi que le maintien de cet état.

L’activité de stérilisation des dispositifs médicaux est subordonnée à l’octroi d’une autorisation mentionnée au 10° de l’article R. 5126-9.

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