Is the irradiation dose of 25 kGy enough to sterilise tissue grafts?

Bone Grafts and Bone Substitutes: Basic Science and Clinical Applications

Volumn , Issue , 2005, Pages 189-212

  Yusof, Norimah ^a  

^a MALAYSIAN NUCLEAR AGENCY   (Malaysia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 34548568182     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1142/9789812775337_0011     Document Type: Chapter

References (23)

1. AAMI (1992) Guidelines for Gamma Radiation Sterilisation (ANSI/AAMIST32-1991,2nd ed.), Arlington, VA, USA.
2. Conway B, Tomford WW, Hirsch MS, Schooley RT and Mankin HJ (1990) Effects of gamma irradiation on HIV-1 in a bone allograft model, Trans. Orthop. Res. Soc. 15:225.
3. Dziedzic-Goclawska A (2000) The application of ionising radiation to sterilise connective tissue allografts: in, Phillips GO (ed.) Radiation and Tissue Banking. World Scientific Publishing, Singapore, pp. 57-99.
4. Dziedzic-Goclawska A and Stachowicz W (1997) Sterilisation of tissue allografts, in: Phillips GO, von Versen R, Strong DM and Nather A (eds.), Advances in Tissue Banking, Vol. 1, World Scientific Publishing, Singapore, pp. 261-321.
5. Hilmy N, Febrida A and Basril A (2000) Validation of radiation sterilization dose for lyophilized amnion and bone grafts, /. Cell Tissue Bank 1:143-148.
6. Hilmy N and Lina M (2001) Effect of radiation on viruses, protein and prions, in: Nather A (tA.), Advances in Tissue Banking, Vol. 5, World Scientific Publishing, Singapore, pp. 358-375.
7. IAEA (1990) Guidelines for Industrial Radiation Sterilisation for Disposable Medical Products, TEC DOC-539, Vienna.
8. IAEA (2002) Code of Practice for the Radiation Sterlization of Tissues Allografts Requirements for Validation and Routine Control (INT/6/052), Vienna.
9. ISO (1995a) Sterilization of Health Care Products - Requirement for Validation and Routine Control - Radiation Sterilization. ISO 11137:1995, Geneva.
10. ISO (1995b) Sterilization of Medical Devices - Microbiological Methods - Part I: Estimation of Population of Microorganisms on Products, ISO 11737-1: 1995, Geneva.
11. ISO (1996) Sterilization of Health Care Products - Radiation Sterilisation -Substantiation of 2 5 kGy as a Sterilisation Dose for Small or Infrequent Product Batches, ISO/TR 13409:1996, Geneva.
12. ISO (1998) Sterilization of Medical Devices - Microbiological Methods - Part 2: ISO 11737-2: 1998, Geneva.
13. ISO (1998) Sterilization of Health Care Products - Radiation Sterilisation -Selection of Sterlization Dose for a Single Production Batch, ISO/TR 15844-1998, Geneva.
14. Kairiyama E (2002) personal communication.
15. Kowalski JB and Tallentire A (1999) Substantiation of 25 kGy as a sterilization dose: a rational approach to establishing verification dose, /. Radiat. Phy. Chem. 54:55-64.
16. Yusof N (1994) The use of gamma irradiation for sterilisation of bones and amnion, Malaysian J. Nucl. Sci. 12(1):243-251.
17. Yusof N (1997) Effect of gamma irradiation and storage on biomechanical properties of human amniotic membrane, in: Proc. 9th Internal. Conf. on Biomedical Engineering, National University Hospital, Singapore, pp. 380-382.
18. Yusof N, Noor Azlan MA, Selamat SN and Lee CM (1994) Radiation sterilised freeze dried bone allograft - Process validation, in: Proc. 7th Internal. Conf. on Biomedical Engineering, National University Hospital, Singapore, pp. 303-305.
19. Yusof N, Marsit NM and Asnah H (1997) Influence of microbiological quality of a product on dose setting for radiation sterilisation, Malaysian J. Nucl. Sci. 15(1&2), 1-8.
20. Yusof N (1999) Quality system for the radiation sterilisation of tissues allografts, in: Phillips GO, von Versen R, Strong DM and Nather A (eds.), Advances in Tissue Banking. Vol. 3, World Scientific Publishing, Singapore, pp. 257-281.
21. Yusof N (2000) Gamma irradiation for sterilising tissue grafts and for viral inactivation, Malaysian J. Nucl. Sci. 18(1):23-35.
22. Yusof N (2001 a) Bioburden estimation in relation to sterilisation, in: Nather A (ed.), Advances in Tissue Banking, Vol. 5, World Scientific Publishing, Singapore, pp. 200-211.
23. Yusof N (2001b) Effect of radiation on microorganisms - mechanism of radiation sterilisation, in: Nather A (ed.) Advances in Tissue Banking, Vol. 5, World Scientific Publishing, Singapore, pp. 342-357.