CONTENTS -- INTRODUCTION TO THE SERIES -- PREFACE -- LIST OF CONTRIBUTORS -- 1 IAEA CODE OF PRACTICE FOR THE RADIATION STERILISATION OF TISSUE ALLOGRAFTS: REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL -- 1. Introduction -- 1.1. Sterilisation of tissue allografts -- 2. Objective -- 3. Scope -- 4. References -- 5. Definitions -- 6. Personnel -- 7. Validation of Pre-sterilisation Processes -- 7.1. General -- 7.2. Qualification of the tissue bank facilities -- 7.3. Qualification of tissue donors -- 7.4. Qualification of tissue processing and preservation -- 7.5. Maintenance of validation -- 7.6. Process specification -- 8. Validation of the Serilisation Process -- 8.1. General -- 8.2. Qualification of the tissue allografts for sterilisation -- 8.3. Qualification of the irradiation facility -- 8.4. Qualification of the irradiation process -- 8.5. Maintenance of validation -- 8.6. Routine sterilisation process control -- 9. Quality, Safety and Clinical Application of the Tissue Allograft -- 10. Documentation and Certification Procedures -- 11. Management and Control -- Annex A. Establishing a Sterilisation Dose -- A.1. Scope -- A.2. Selection of tissue allograft products -- A.3. Sample item portion (SIP) -- A.4. Bioburden determination -- A.5. Verification dose experiments -- A.6. Procedures -- A.7. Routine use of sterilisation doses -- Annex B. Sterilisation of Tissue Allografts (Examples of Sterilisation Procedures) -- B.1. Limited number of amnion samples with low bioburden and low bacterial resistance using method 1 of ISO 11137:1995 to cal -- B.2. Limited number of amnion samples requiring only substantiation of 25 kGy as a sterilisation dose -- B.3. Limited number of bone samples with very low bioburden and SDR using ISO/TR 13409:1996 to calculate the verification dose (SIP < 1) -- Annex C. Tables 1, 2 and 3.

Annex D. Key References for the Sterilisation of Tissues by Ionising Radiation -- D.1. Bone -- D.2. HIV -- D.3. Biomaterials -- B.4. Soft tissues -- 2 PRESERVED BONE ALLOGRAFTS IN RECONSTRUCTIVE ORTHOPAEDICS -- 1. Introduction -- 2. Transplantation of Lyophilised and Radiation-Sterilised Bone Grafts -- 3. Transplantation of Deep-Frozen and Radiation-Sterilised Allogenic Bone Grafts -- 4. Conclusion -- 5. References -- 3 CLINICAL STRATEGY FOR APPLICATION OF DEEP FROZEN-RADIATION STERILISED BONE ALLOGRAFTS -- 1. Introduction -- 2. Methods and Results -- 3. Examples of Graft Use in Specific Clinical Situations -- 4. Conclusions -- 5. References -- 4 CLINICAL RESULTS AND ORGANISATIONAL ASPECTS OF AUTOGENOUS AND ALLOGENOUS BONE GRAFTING IN THE TREATMENT OF 226 PATIENTS WITH PRIMARY OSSEOUS NEOPLASMS -- 1. Introduction -- 2. Clinical Data -- 3. Discussion -- 5 NEW APPROACHES TO COMPARATIVE EVALUATION OF ALLOGENIC AND AUTOLOGOUS BONE TRANSPLANTS PROCURED IN VARIOUS WAYS -- 1. Introduction -- 2. Material and Methods -- 3. Results -- 4. Discussion -- 5. References -- 6 THE USE OF FREEZE-DRIED MINERALISED AND DEMINERALISED BONE -- 1. Introduction -- 2. Aims and Equipment for Freeze Drying* -- 3. Properties of Freeze Dried Bone -- 3.1. Mechanical properties -- 3.2. Biological properties -- 4. Preparation of Bone to be Freeze Dried -- 5. Clinical Indications of Freeze Dried Bones -- 5.1. Non-demineralised bone -- 5.2. Demineralised bone -- 6. Conclusions -- 7. References -- 7 PRESERVED ALLOGENIC RIB CARTILAGE IN RECONSTRUCTIVE SURGERY -- 1. Introduction -- 2. Material -- 3. Observation -- 4. Conclusion -- 5. References -- 8 BONE SUBSTITUTES AND RELATED MATERIALS IN CLINICAL ORTHOPAEDICS -- 1. Introduction -- 2. Calcium Phosphates -- 2.1. Calcium phosphates of biologic origin, bone-derived, bone apatite -- 2.2. Tricalcium phosphates, TCP -- 2.3. Coralline HA.

2.4. Natural coral - calcium carbonate -- 2.5. Injectable materials -- 2.6. Calcium sulphate, plaster of Paris -- 3. Bioactive Glass and Glass Ceramics -- 4. Polymers -- 4.1. Polymethylmetacrylates (PMMA) and cements -- 5. Metals -- 6. Bone and Bone-Derived Materials -- 6.1. Bone tissue banking -- 6.2. Bone-derived biologically active substances -- 7. Conclusions -- 9. References.