S.L. 483.6 Art. 6Requirements for the procurement of human organs. Organ and donor characterisation.

(1) Medical activities in procurement organisations, such as donor selection and evaluation, shall be performed under the advice and the guidance of a doctor of medicine as referred to in Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications.

(2) Procurement shall take place in operating theatres, which are designed, constructed, maintained and operated in accordance with adequate standards and best medical practices so as to ensure the quality and safety of the organs procured.

(3) Procurement materials and equipment shall be managed with due regard to relevant national and international regulations, standards and guidelines covering the sterilisation of medicines and medical devices. Qualified, sterile instruments and procurement devices shall be used for organ procurement.