Part Three: Combating disease and addiction

Processes and equipment intended for the disinfection provided for in article L. 3114-1 are subject to the provisions of this section, notwithstanding the application of the provisions of the law of 28 October 1943 relating to steam and gas pressure equipment on land or on board inland waterway vessels.

Appliances of an approved type bear a serial letter corresponding to the type to which they belong and a serial number within this series.

The experiments prior to approval are carried out under the supervision of the Agence nationale de sécurité du médicament et des produits de santé and are intended to establish whether the process and the device meet the efficacy and safety criteria set by order of the Minister for Health. This order also determines the content of the application for approval and in particular the necessary information on the description and…

The applicant shall provide the elements required for the experiments and, if necessary, on request, the personnel required to carry out these experiments.

The minutes of the experiments are communicated to the interested parties. They have fifteen days to submit their observations.

The interested party is notified of the approval decision. If the application for authorisation remains unanswered for more than four months, it will be deemed to have been rejected.

Approval is granted for a period of ten years.

Approved disinfection equipment, its use and the processes used for disinfection are monitored by the regional health agency and the Agence nationale de sécurité du médicament et des produits de santé.