Testing of dental materials helps to ensure that they are of satisfactory quality. Most standardized testing programs have focused on the physical, chemical, and mechanical properties of the materials, and started at the National Bureau of Standards, USA, in 1919. The need for biological evaluation of dental materials became evident after some material-related adverse incidents. The first document concerning standardized testing of the biological properties of dental materials was published by the American Dental Association in 1972. During the last twenty-five years, increased attention has been focused on the evaluation of biological properties by standardized testing. The development of standards concerning biological testing of dental materials since 1972 at the national and international level is described.
1. Paffenbarger, G. C., J. A. Tesk and W. E. Brown. 1985. "Dental Research at the National Bureau of Standards: How It Changed the Practice of Dental Health Service,"J. Am. Dent. Assoc., 111:83-89.
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2. Tyas, M. J.1991. "Dental Materials Science—The Maintenance of Standards,"J. Oral Rehabil., 18:105-110.
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3. Mjor, I. A.1990. "Current Views on Biological Testing of Restorative Materials,"J. Oral Rehabil., 17:503-507.
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4. American Dental Association. 1972. "Recommended Standard Practices for Biological Evaluation of Dental Materials,"J. Am Dent. Assoc., 84:382-387.
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5. American Dental Association. 1979. "American National Standards Institute/American Dental Association Document No. 41 for Recommended Standard Practices for Biological Evaluation of Dental Materials,"J. Am. Dent. Assoc., 99:697-698.
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6. British Standards Institution. 1989. Methods of Biological Assessment of Dental Materials. BS 5828.
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7. Deutsches Institut fur Normung E. V. 1990. Biologische Prufungen von Dentalwerkstoffen. DIN V 13930.
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8. Association Suisse de Normalisation. 1990. Evaluation Biologique des Materiaux Dentaires. SN 119800.
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9. Stanford, J. W.1987. "Importance of International Standardization of Dental Products,"J. Dent. Res., 66:1782.
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10. Federation Dentaire Internationale. 1980. "Recommended Standard Practices for Biological Evaluation of Dental Materials,"Int. Dent. J., 30:140-188.
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11. International Organization for Standardization. 1984. Biological Evaluation of Dental Materials. ISO/TR 7405.
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12. Association Francaise De Normalisation. 1985. Evaluation Biologique des Produits Dentaires. NF S91-224.
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13. International Organization for Standardization. 1994. Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry. ISO/CD/TR 7405.
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14. International Organization for Standardization. 1992. Biological Testing of Medical Devices, Part 1: Guidance on Selection of Tests. ISO 10993-1:1992.
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15. International Organization for Standardization. 1992. Biological Testing of Medical Devices, Part 2: Animal Welfare Requirements. ISO 10993-2:1992.
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16. International Organization for Standardization. 1992. Biological Testing of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity. ISO 10993-3:1992.
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17. International Organization for Standardization. 1992. Biological Testing of Medical Devices, Part 4: Selection of Tests for Interactions with Blood. ISO 109934:1992.
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18. International Organization for Standardization. 1992. Biological Testing of Medical Devices, Part 5: Tests for Cytotoxicity: In Vitro Methods. ISO 10993-5:1992.
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19. International Organization for Standardization. 1994. Biological Testing of Medical Devices, Part 6: Tests for Local Effects after Implantation. ISO 10993-6:1994.
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20. International Organization for Standardization. 1994. Biological Testing of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals. ISO/DIS 10993-7:1994.
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21. International Organization for Standardization. 1994. Biological Testing of Medical Devices, Part 9: Degradation of Materials Related to Biological Testing. ISO/TR 10993-9:1994.
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22. International Organization for Standardization. 1994. Biological Testing of Medical Devices, Part 10: Tests for Irritation and Sensitization. ISO 10993-10:1994.
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23. International Organization for Standardization. 1993. Biological Testing of Medical Devices, Part 11: Tests for Systemic Toxicity. ISO 10993-11:1993.
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24. International Organization for Standardization. 1994. Biological Testing of Medical Devices, Part 12: Sample Preparation and Reference Materials. ISO/DIS 10993-12:1994.
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25. International Organization for Standardization. 1994. Clinical Investigations of Medical Devices. ISO/DIS 14155:1994.
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26. The Council of the European Communities. 1993. "Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices,"Official Journal of European Communities No L169, pp. 1-43.
