| 1) | A holder of an authority who applies a Group IV hazardous substance for medical purposes shall ensure that— |
| a) | appropriate special precautions are taken in the case of the irradiation of persons under the age of 18 years and of fertile and pregnant women, on whom only essential examinations may be carried out; |
| b) | a record is kept of every patient who is exposed to radiation emitted from such substance for diagnostic and therapeutic purposes, in which record the details of and the reason for such exposure shall be recorded; and |
| c) | a record is kept of the radio-therapeutic treatment given to patients, in which record is indicated the parts of the body irradiated, the Group IV hazardous substance used for the treatment, the tumour dose and all relevant data on which the calculation of such dose is based. |
| 2) | A holder shall ensure that any equipment or apparatus under his control— |
| a) | that contains a Group IV hazardous substance and that is used for medical exposure; or |
| b) | that is intended for use with such substance, |
is of such design or construction and is installed and maintained and calibrated in such a way that the exposure to ionising radiation of any person who is undergoing a medical exposure may, as far as is reasonably practicable, be restricted to a minimum that is reconcilable with the intended clinical purpose or research objective.
| 3) | In the case of a holder knowing, having reasonable grounds to believe, suspecting or being informed that an incident may have occurred in which a person, while undergoing medical exposure with a Group IV hazardous substance covered by a holder's authority, has been exposed to ionising radiation to a greater or lesser extent than intended, the holder shall— |
| a) | immediately investigate the suspected incident and, unless such investigation finds beyond reasonable doubt that no such incident occurred, shall forthwith notify the Director-General thereof by telephone, telegram, telefacsimile or other similar rapid means; and |
| b) | investigate in detail or arrange for such an investigation into the circumstances surrounding the exposure and shall make or cause to be made an assessment of the dose received. |
| 4) | A holder who conducts any investigation in accordance with subregulation (3) shall compile a report on that investigation and shall furnish such report to the Director-General. |
| 5) | Where an employee has reasonable grounds to believe that an incident referred to in subregulation (3) has occurred, the holder of the authority shall forthwith be informed of his suspicion. |
| 6) | A holder who uses, for medical purposes, a Group IV hazardous substance with an activity of 370 megabecquerel or more shall make use of the services of a medical physicist. |
