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BijinV replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 6 months ago
In order to determine what biocompatibility testing a device needs, ISO 10993 can be referenced. There are various tests and requirements that need to be evaluated for each medical device based on its intended use and duration of use and location of use. The most broadly applied tests are cytotoxicity, sensitization, and irritation/intracutaneous reactivity; which are required for every investigational device. The table then identifies additional tests based on the nature of the device interaction with the human body. For specific organs, additional biocompatibility testing with cells from the designated area will need to be considered, as well as more thorough types of tests (carcinogenicity, acute and chronic toxicity, etc).