<strong>of</strong> such testing requirements and guidelines as described in this article. In general, harmonized standards and guidelines augment the confidence level in a safety assessment procedure, wherever it is conducted. The endeavor in all safety assessment, as in all scientific investigations, is toward good scientific practices and rationale that will be applied toward protecting the population. The rest <strong>of</strong> the details will generally fall into place on their own. REFERENCES 1. "Biological Evaluation <strong>of</strong> <strong>Medical</strong> <strong>Devices</strong>," ISO 10993, parts 1–12. (Geneva: International Organization for Standardization, various dates ). 2. "Use <strong>of</strong> International Standard ISO 10993, Biological Evaluation <strong>of</strong> <strong>Medical</strong> <strong>Devices</strong>—Part 1: Evaluation and Testing" G95-1 (Rockville, MD: Department <strong>of</strong> Health and Human Services, FDA, 1995). 3. "Testing Methods to Evaluate Biological <strong>Safety</strong> <strong>of</strong> <strong>Medical</strong> <strong>Devices</strong>, Notice from the Office <strong>Medical</strong> <strong>Devices</strong> Evaluation Number 36" (Pharamaceutical and Food <strong>Safety</strong> Bureau, Ministry <strong>of</strong> Health, Labour and Welfare, March 19, 2003). 4. "A Practical Guide to ISO 10993," parts 1–12, <strong>Medical</strong> Device & Diagnostic Industry 20, no. 1, 2, 4–12, and 21, no. 1 (January 1998–January 1999). 5. "Ninth Addendum to the Organization for Economic Cooperation and Development (OECD)," Guidelines for the Testing <strong>of</strong> Chemicals.(Paris: OECD February 1998). 6. "Tenth Addendum to the Organization for Economic Cooperation and Development (OECD)," Guidelines for the Testing <strong>of</strong> Chemicals (Paris: OECD, October 1998). 7. "Standard Procedure for Evaluation <strong>of</strong> Material Extracts by Systems Injection in Mice (Method A: Intravenous),"ASTM F750 in Annual Book <strong>of</strong> ASTM Standards, sec. 13, <strong>Medical</strong> <strong>Devices</strong> and Services (West Conshohocken, PA: American Society for Testing and Materials, 1996). 8. "Biological Reactivity Tests In Vivo" United States Pharmacopoeia 24, National Formulary 19, (2000). 9. "S2B Guidelines on Genotoxicity: A Standard Battery for Genotoxicity Testing <strong>of</strong> Pharmaceuticals" (Geneva: International Conference on Harmonization, July 1997). 10. JH Draize, Appraisal <strong>of</strong> the <strong>Safety</strong> <strong>of</strong> Chemicals in Food, Drugs, and Dosmetics (Austin, TX: Association <strong>of</strong> Food and Drug Officials <strong>of</strong> the United States), 49–51. 11. TO McDonald and JA Shadduck: "Eye Irritation," Advances in Modern Toxicology," vol. 4, (New York: Wiley, 1977), 162. 12. "Evaluation <strong>of</strong> Hemodialyzers and Dialysis Membranes," (Bethesda, MD: Artificial Kidney—Chronic Uremia Program <strong>of</strong> the National Institute <strong>of</strong> Arthritis, Metabolism, and Digestive Diseases, U.S. Department <strong>of</strong> Health, Education, and Welfare/National Institutes <strong>of</strong> Health ,1977). 13. John Autian, Authorized Toxicity Testing Protocols, vol. I (ATTP-I) (Memphis: Materials Science Toxicology Laboratories, University <strong>of</strong> Tennessee Center for the Health Sciences, April 1977). 14. "Standard Practice for the <strong>Assessment</strong> <strong>of</strong> Hemolytic Potential Properties <strong>of</strong> Materials,"ASTM F756, in Annual Book <strong>of</strong> ASTM Standards, sect. 13, <strong>Medical</strong> <strong>Devices</strong> 18
and Services (West Conshohocken, PA: American Society for Testing and Materials, 1996). Laxman S. Desai D.Sc. is the Scientific Director and Laurence Lister is the Director for the <strong>Biocompatibility</strong> Division <strong>of</strong> the <strong>Toxikon</strong> Corporation, (15 Wiggins Avenue Bedford, MA, 01730, USA). 19
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