Accidental and unintended exposures
Article 63
Member States shall ensure that: (a) all reasonable measures are taken to minimise the probability and magnitude of accidental or unintended exposures of individuals subject to medical exposure; (b) for radiotherapeutic practices the quality assurance programme includes a study of the risk of accidental or unintended exposures; (c) for all medical exposures the undertaking implements an appropriate system for the record keeping and analysis of events involving or potentially involving accidental or unintended medical exposures, commensurate with the radiological risk posed by the practice; (d) arrangements are made to inform the referrer and the practitioner, and the patient, or their representative, about clinically significant unintended or accidental exposures and the results of the analysis; (e) (i) the undertaking declares as soon as possible to the competent authority the occurrence of significant events as defined by the competent authority; (ii) the results of the investigation and the corrective measures to avoid such events are reported to the competent authority within the time period specified by the Member State; (f) mechanisms are in place for the timely dissemination of information, relevant to radiation protection in medical exposure, regarding lessons learned from significant events.