Radiation Sterilization of Tissue Allografts: Requirements for Validation and Routine Control

Recommendations and guidelines are presented for the safe use of ionizing radiation as a sterilization procedure for tissue allografts. The recommendations were produced by the IAEA with the help and approval of the main professional associations of tissue banks in Europe, Latin America and the USA and by experts in all aspects of radiosterilization and transplantation procedures. The code of practice covers the recommended qualifications of the tissue bank facilities, the tissue donors, the tissue processing and preservation procedures, and the maintenance of validation of the pre-sterilization and sterilization processes. Also covered are the quality, safety and clinical application of the tissue allografts, documentation and certification procedures, management and control issues, establishing a sterilization dose and worked examples.