Commentaries: Art. 50

Licence holders must keep a record of medical radiation incidents.
They must, with an interdisciplinary working group, regularly analyse any incidents which have occurred and make the operational adjustments required to prevent similar incidents.
They must report the following medical radiation incidents to the supervisory authority within 30 days:
1. unplanned exposures which led or could have led to moderate organ damage, moderate functional impairment or more serious damage in the patient;
2. confusion of patients or organs in therapeutic exposures or in diagnostic exposures in the high-dose range;
3. unplanned exposures where the patient received an effective dose of more than 100 mSv.
⁴In the case of medical radiation incidents as specified in paragraph 3, the licence holder must conduct an investigation and submit a report in accordance with Article 129.