S.L. 585.1 Art. 79Compliance.

(1) The undertaking shall ensure that:

(a) all new equipment has an EC Declaration of conformity;

(b) all new equipment has, where practicable, a device showing the quantity of the radiation produced by the equipment;

(c) an up to date inventory of radiological equipment for each radiological installation is available;

(d) When radiological equipment is not being used it must be left in a safe and secure condition and when it is in use it must be kept under strict surveillance regarding radiation

(e) when in use the equipment must be adequately supervised to ensure an adequate level of radiation protection;

(f) appropriate routine maintenance is performed (in line with manufactures recommendations);

(g) appropriate quality assurance programmes are in place, including a schedule for testing the equipment;

(h) appropriate quality assurance programmes for assessing patient dose or administered activity;

(i) suitable measures are taken to improve inadequate or defective features of the equipment;

(j) that there are suitable measures for putting equipment into clinical use and removal from clinical use;

(k) there is clear allocation of responsibilities for who can declare that the equipment is fit/unfit for clinical use;

(l) 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;

(m) reasonably steps to prevent failure of radiation equipment where such failure could result in exposure of patients to ionising radiation greater than intended;

(n) on becoming aware of defects in equipment during use, the undertaking assesses in consultation with the supplier (or where relevant the service agent or original manufacturer) and the medical physics expert, if appropriate, whether any further action is necessary;

(o) shall have a contingency plan for responding to equipment failures or malfunction. Following equipment failure and subsequent repair, the undertaking should consider the likelihood and consequences of recurrence before returning the equipment to clinical use.

(2) If the equipment is going to be taken out of clinical use, with no intention of scrapping, then the undertaking shall remain responsible for that equipment and if the equipment is sold, leased or given to another approved undertaking, than the Secretariat shall be notified prior to this happening.