Biocompatability Standards (ISO 10993)

Biocompatability Standards (ISO 10993) – Dr. Robert J. Staab

Discussion of the FDA Guidance for biocompatibility testing of medical devices will focus on the “Use of International  Standard ISO-10993,  Biological Evaluation of Medical Devices Part-1:  Evaluation and Testing,"  This has as its central purpose a guidance for determining which toxicity tests are needed for various medical devices and uses. Discussion of the utility of the  flow chart provided by ISO and adopted by FDA for choosing appropriate test programs will take place. This guidance has replaced the similar "Tripartite  Biocompatibility Guidance", In 1986, FDA, Health and Welfare Canada, and Health and Social Services  UK issued the original guidance.  In order to harmonize biological response testing with the requirements of other countries, FDA applied the ISO standard, Both the predicate guidance and the current guidance still has as its purpose the determination of the potential toxicity resulting from contact of the component materials of the device with the body including local or systemic effects, carcinogenicity; and adverse reproductive and developmental effects.  We will discuss the toxicology models to assess these endpoints: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental effects.  Further discussion will address the use of well characterized physical and chemical materials and the diminished need for full testing and the use of scientific judgment in determining which tests are required.