Validation and substantiation of 25 kGy as sterilization dose for lyophilized human amnion membrane

Cell and Tissue Banking

Volumn 8, Issue 1, 2007, Pages 9-12

  Djefal, A ^a   Tahtat, D ^a   Nacer Khodja, A ^a   Saad Bouzid, S ^a   Remane, N ^a  

^a CENTRE DE RECHERCHE NUCLÉAIRE D ALGER   (Algeria)

Author keywords

Bioburden; Human amniotic membrane; ISO13409; Sterilization dose substantiation; Validation

Indexed keywords

COBALT 60;

AEROBIC BACTERIUM; AMNION; ANAEROBIC BACTERIUM; ARTICLE; BACTERIAL COUNT; BACTERIUM CONTAMINATION; DOSIMETRY; FREEZE DRYING; GAMMA RADIATION; GOOD MANUFACTURING PRACTICE; HUMAN; HUMAN TISSUE; NONHUMAN; PRIORITY JOURNAL; RADIATION DOSE; RADIATION DOSE DISTRIBUTION; VALIDATION PROCESS;

AMNION; BACTERIA; DOSE-RESPONSE RELATIONSHIP, RADIATION; FEMALE; FREEZE DRYING; GAMMA RAYS; HUMANS; PREGNANCY; STERILIZATION;

EID: 33847069219     PISSN: 13899333     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10561-006-9016-x     Document Type: Article

References (12)

1. Djefal A, Mahlous M, Nacer Khodja A, Larbi Daho Bachir M (1997) Freeze dried radiosterilized human amniotic membrane in the treatment of burn wound. Alg Rev Nuc Sci 1(1):45-48
2. Hilmy N, Febrida A, Basil A (2000) Validation of radiation sterilisation dose for lyophilized amnion and bone grafts. Cell Tissue Bank 1:143-148
3. Jefferson S, Crawford CG (1967) Development of industrial sterilization of medical products. Proceedings of the symposium on radiosterilization of medical products held by the international atomic energy agency, Budapest, pp 361-365
4. Judlin P, Lejeune V, Quentin R, Abdelmoumene N, Aujard Y, Fréte F, Giglio V, Kacet N, Ledare D, Lucas couturier L, Minguet C, Poulain P, Wollner A (2001) Prévention anténatale du risque infectieux bactérien néonatal précoce. Agence nationale d'accréditation et d'évaluation en santé. Service des recommandations et références professionnelles, France, 38 pp
5. IAEA (2001) Code of practice for the radiation sterilisation of tissue Allograft Requirements for validation and routine control. The IAEA IN/6/052 programme in radiation and tissue Banking
6. ISO 11137 (1995) Sterilization of health care products - Requirement for validation and routine control - Radiation sterilisation. International Standard Organisation, Geneva
7. ISO 11737-1 (1995) Sterilisation of medical devices - Microbiological methods - Estimation of population of microorganisms on products. International Standard Organisation, Geneva
8. ISO/TS 13409 (2002) Sterilization of health care products - Radiation sterilisation - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches. International Standard Organisation, Geneva
9. Mesli MF, Mokhtari A (2002) Biostatiatique description et analyse des données en médecine et en biologie, 1er édn. Les éditions universitaires le Fennec, Oran, 77 pp
10. Mitiche D, Larbi Dahou BM, Bouatou F, Abchiche MO, Djefal A, Mahlous M (1999) Utilisation des membranes amniotiques chez les brǔles - A propos de 25 cas. Annals Burns Fire Disasters XII(1):23-24
11. Tabei M, Sekiguchi M (1995) Evaluation of sterilisation dose for disposable hypodermic needles manufactured under ultra cleaned condition. Radiat Phys Chem 46(4-6):629-632
12. Zimek Z, Kaluska I (2002) Sterilization dose auditing for various types of medical products. Radiat Phys Chem 63:673-674 673-674