Finally, any incident or accident liable to be the cause of over-exposure of an individual must be immediately declared to the Prefect of the department and to the ASN. For this purpose, the ASN has a hot-line reserved for emergency situations (toll-free number: 0 800 804 135) accessible 24 hours a day (see chapter 8, point 1.1.3) but it can of course also be used for any radiological incident occurring in a medical installation.

In addition, article R. 162-53 of the Social Security Code, states that: "Practitioners and establishments using appliances generating ionising radiation or comprising the use of radionuclides or products containing them, for therapeutic or diagnostic purposes, may only carry out examinations or give treatment to persons covered by social security insurance if the appliances and installations have been declared or licensed as mentioned in articles R. 1333-22 and R. 1333-24 of the Public Health Code. Only those radiological examinations and radiotherapy treatments carried out using appliances and installations declared or licensed in the conditions laid out in the previous paragraph may be reimbursed or paid for".

Paragraph 3.3 describes the contents of the notificationn and licence application files specified in articles R. 1333-22 and R. 1333-24. The order of 14 May 2004, based on article R. 1333-44, specifies the practicalities for implementation of these procedures.

These rules, already presented in chapter 3, point 1.2.4, of course also apply to the medical and biomedical fields. They concern:

• the obligation to have a licence for all transfer, acquisition, possession or use of sources;
• preliminary registration of all source movements to the IRSN;
• book keeping by the beneficiary of the licence of detailed accounts for the sources in his possession, and their movements;
• immediate notification to the Prefect and the ASN of any loss or theft of radioactive sources;
• return by the user to its suppliers - who are then obliged to take them - of sealed sources that have expired, are damaged or are no longer needed.

The procedure involving notification to the department Prefect concerns the use of electric appliances generating X-rays for medical or dental diagnostic purposes - except for installations classified as sophisticated equipment (article R. 1333-22). Publication of the order of 14 May 2004 concerning the standard licensing and notification system defined in chapter V.I "Ionising radiation" of the Public Health Code, allows implementation of this procedure, which definitively replaces the approval procedure.

The notification is to be submitted on a form that can be downloaded from the ASN's website (www.asn.gouv.fr) or obtained from the DSNRs (Nuclear Safety and Radiation Protection Divisions). For each establishment using medical or dental radiology appliances, only a single notification mentioning all the radiological installations has to be provided. When the dossier is considered to be complete by the DSNR, the Prefect sends back to the declaring party an acknowledgement of notification of a radiodiagnostic installation, recalling the general conditions to which its operation is subject..

After a five-year period, a further notification must be submitted. If, prior to expiry of the period of validity, significant modifications are made to the notification (change in or addition of appliance, transfer or substantial modification of the premises or change in the practitioner responsible), the Prefect must be immediately notified accordingly.

The notification dossier must comprise the reports of the inspections conducted, in application of articles R. 1333-43, R. 5211 and R. 5212-25 to R. 5212-32 of the Public Health Code and R. 231-84 of the Labour Code (protection of workers against the hazards of ionising radiation). If inadequacies are observed during these inspections, a report describing the remedial measures taken must be submitted along with the notification dossier.

The declared installations must be:
• equipped with a generator less than 25 years old (the case of medical appliances used for medical treatment) carrying CE labelling guaranteeing conformity with the essential health and safety requirements mentioned in article R.665-12 of the Public Health Code, if they entered service after June 1998;
• fitted out in accordance with standards NFC 15-160, NFC 15-161 (medical radiology) and NFC 15-163 (dental radiology).