SCHEDULE 1U.K.Licences for the purposes of regulation 5

3.  It shall be a condition of a licence for a procurement activity for the licence holder—U.K.

(a)to ensure that procurement material and equipment which could affect the quality and safety of an organ are managed in accordance with relevant F1..., international and national legislation, standards and guidelines on the sterilisation of medical devices; and

(b)to have in place operating procedures demonstrating how the requirements in sub-paragraph (a) shall be complied with.