The Development of a Code of Practice for the Radiation Sterilisation of Tissue Allografts

Abstract International Standards have already been developed concerning the use of ionising radiation for the sterilisation of health care products ( ISOs 11137:95, ISO/TR 13409:1996, AAMI/TIR 27:2001 ). The International Atomic Energy Agency (IAEA) has been engaged in the development of a similar Code for the sterilisation of tissue allografts by ionising radiation. The process has been informed by the current best practice throughout the world and involved consultation with tissue bank practitioners, particularly in Central and South America, as well as in parts of Asia and Europe. This paper gives some of the essential features of the draft Code and in particular addresses the problems associated with non-uniformity of tissue allograft samples and also with the possibility of viral contamination. These and other issues crucial to the development of an international Code of Practice are described here.