Biocompatibility Testing and the ISO 10993 Challenge
Any medical device that contacts the human body must be evaluated for biocompatibility. The ISO 10993 family of standards defines how this evaluation should be conducted, covering cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects, and more. The requirements depend on the nature and duration of body contact, which means a surgical suture, an infusion...
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