Council Directive 2013/59/EuratomShow full title

Article 60 Equipment

1. Member States shall ensure that:

(a) all medical radiological equipment in use is kept under strict surveillance regarding radiation protection;

(b) an up-to-date inventory of medical radiological equipment for each medical radiological installation is available to the competent authority;

(c) appropriate quality assurance programmes and assessment of dose or verification of administered activity are implemented by the undertaking; and

(d) acceptance testing is carried out before the first use of the equipment for clinical purposes, and performance testing is carried out thereafter on a regular basis, and after any maintenance procedure liable to affect the performance.

2. Member States shall ensure that the competent authority takes steps to ensure that the necessary measures are taken by the undertaking to improve inadequate or defective performance of medical radiological equipment in use. They shall also adopt specific criteria for the acceptability of equipment in order to indicate when appropriate corrective action is necessary, including taking the equipment out of service.

3. Member States shall ensure that:

(a) the use of fluoroscopy equipment without a device to automatically control the dose rate, or without an image intensifier or equivalent device, is prohibited.

(b) equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV has a device to verify key treatment parameters. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

(c) any equipment used for interventional radiology has a device or a feature informing the practitioner and those carrying out practical aspects of the medical procedures of quantity of radiation produced by the equipment during the procedure. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

(d) any equipment used for interventional radiology and computed tomography and any new equipment used for planning, guiding and verification purposes has a device or a feature informing the practitioner, at the end of the procedure, of relevant parameters for assessing the patient dose.

(e) equipment used for interventional radiology and computed tomography has the capacity to transfer the information required under 3(d) to the record of the examination. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

(f) without prejudice to points (c), (d) and (e) of paragraph 3, new medical radiodiagnostic equipment producing ionising radiation has a device, or an equivalent means, informing the practitioner of relevant parameters for assessing the patient dose. Where appropriate, the equipment shall have the capacity to transfer this information to the record of the examination.