These dossiers concern the following installations:
• X-ray tomography and digitised angiography;
• radiotherapy (particle accelerators, telegammatherapy and brachytherapy appliances);
• nuclear medicine;
• biomedical research on human beings in one of the above-mentioned disciplines, subject to a "Huriet law" biomedical research protocol, which are subject to prior licensing by the Minister for Health (article R. 1333-24 of the Public Health Code), valid for a maximum renewable period of 5 years, issued by the ASN to the practitioners who are responsible for them.

For each installation mentioned above, the corresponding dossier is to be drawn up using a form that can be downloaded from the ASN's website (www.asn.gouv.fr). These dossiers, accompanied by the required documents, are to be returned to the ASN for examination, either through the DSNR (scanner, digital angiography, radiotherapy), or the ASN (nuclear medicine, brachytherapy and biomedical research).

The licence is granted on the basis of criteria concerning necessity (in particular the case of installations classified as sophisticated equipment), the competence of the practitioner in charge, and conformity with the installation technical arrangement and layout rules and the radiation protection organisation. Furthermore, the appliances mentioned above may not be used once they are more than 25 years old.

In the case of nuclear medicine, particular attention will be given to the collection and disposal of the waste and radioactive effluent produced. For instance, the dossier must comprise a waste and effluent management plan for the entire establishment within which the nuclear medicine unit is located.

If biomedical research is performed in one of the above disciplines, the criterion of competence of the practitioners in charge of this research and the technical rules concerning the installations remain applicable.

The ASN issued 522 decisions (commissioning or renewal licences, cancellation notifications) according to the breakdown given in table 4

In April 2005, the Grenoble university hospital submitted a notification to the ASN and the AFSSAPS concerning a serious incident which occurred in the first quarter of 2003 during radiotherapy treatment. This incident led to exposure of a patient to a dose about 20% higher than that initially planned for his treatment. This over-exposure was only detected in the patient in November 2004 further to a complication requiring surgery.

This incident, which is the first of this type declared to the ASN, was due to an anomaly in transmission of the computer data to the radiotherapy appliance used, a fact that was brought to light by the university hospital in May 2003 and corrected. The results of the investigations carried out show that the problem could only occur in a specific configuration on only one of the radiotherapy appliances in service between June 2002 (date the appliance was installed) and May 2003 (date on which the problem was corrected).

As soon as they became aware of this incident, the ASN and the AFSSAPS, together with the Isère DDASS, carried out investigations during the course of inspections in the university hospital radiotherapy unit, to check the organisation of radiation protection in the preparation and performance of the treatment, to assess the IT system and monitor its conditions of use.

Following this event, the ASN and AFSSAPS sent a letter dated 26 April 2005 to all of the 180 French radiotherapy units in order to recall the main provisions concerning patient radiation protection and the regulatory obligations concerning equipment supervision, maintenance and inspection of radiotherapy installations. This circular can be consulted on the ASN's website (www.asn.gouv.fr).