S.L. 585.1 Art. 74Acceptance testing.

(1) Acceptance testing must be carried out in accordance with international standards. The standard to be used shall be accepted by the Commission.

(2) Acceptance tests need to be carried out on installation or relocation of equipment.

Testing for performance, equivalent to an acceptance test or parts thereof shall be carried out:

(a) after major adjustments of functional parameters, repairs or maintenance have been performed;

(b) after components or sub-assemblies have been added, modified, replaced or removed;

(c) after each time the undertaking has to remove the equipment from clinical use due to a malfunction or maintenance that could affect the patient dose;

(d) if tests show that the equipment has or is producing doses other than the acceptable levels.

(3) Acceptance test results should be compared to and meet the manufacturer’s tolerances. In the absence of such, as in the case of aged equipment then European Union criteria for acceptability may be used.

(4) After the acceptance testing is carried out, the test reports and any other relevant documentation has to be passed on the Secretariat. The Information to be supplied to the Secretariat with regard to acceptance tests that have been performed is given in the Eighteenth Schedule

(5) The records for such testing shall be kept for the lifetime of the equipment.

(6) In order to set up the optimal clinical operation of the equipment, certain commissioning tests may be required to be performed, such as setting up exposure protocols.