Council Directive 97/43/Euratom (repealed)Show full title

Article 8 Equipment

1. Member States shall take such steps as they may consider necessary with a view to avoiding unnecessary proliferation of radiological equipment.

2. Member States shall ensure that:

• all radiological equipment in use is kept under strict surveillance regarding radiation protection,

• an up-to-date inventory of radiological equipment for each radiological installation is available to the competent authorities,

• appropriate quality assurance programmes including quality control measures and patient dose or administered activity assessments are implemented by the holder of the radiological installation, and

• acceptance testing is carried out before the first use of the equipment for clinical purposes, and thereafter performance testing on a regular basis, and after any major maintenance procedure.

3. Competent authorities shall take steps to ensure that necessary measures are taken by the holder of the radiological installation to improve inadequate or defective features of the equipment. They shall also adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, including, if appropriate, taking the equipment out of service.

4. In the case of fluoroscopy, examinations without an image intensification or equivalent techniques are not justified and shall therefore be prohibited.

5. Fluoroscopic examinations without devices to control the dose rate shall be limited to justified circumstances.

6. If new radiodiagnostical equipment is used, it shall have, where practicable, a device informing the practitioner of the quantity of radiation produced by the equipment during the radiological procedure.