Abstract
Biocompatibility testing is an essential requirement for regulatory approval of medical devices such as a medical textile product. This chapter introduces the basic concept of biocompatibility testing outlined by the International Organization for Standardization (ISO), and describes the many tests developed for the evaluation of potential biological risks arising from the use of a medical textile product. In particular, some of the commonly used biocompatibility test methods, such as cytotoxicity testing, sensitization testing, irritation testing, systemic toxicity testing, genotoxicity testing, implantation testing, and hemocompatibility testing, are outlined.
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