time:2025-05-26 09:01:17 Smart Hardware
Routine five tests for biocompatibility
The five routine tests for biocompatibility mainly include cytotoxicity test, sensitization test, stimulation test, systemic toxicity test, and genotoxicity, carcinogenicity and reproductive toxicity test.Cytotoxicity test: This is an important test to evaluate the effect of a medical device or material on cell growth and viability. In vitro cell culture is usually used to observe the effect of the material extract on cell growth, morphology, and function to determine whether it is cytotoxic. Sensitization test: Used to assess whether a medical device or material may cause an allergic reaction. This is usually done by skin contact test or subcutaneous injection test to see if the test animal shows symptoms of an allergic reaction. Stimulation test: Evaluates the irritating effect of a medical device or material on local tissues. This can be observed through a skin or mucosal contact test to see if there are any irritation symptoms such as redness, swelling, pain, etc. Systemic toxicity test: Evaluates the toxic effects of a medical device or material on a systemic scale.
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