ISO 10993:5 Cytotoxicity Testing Methods
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Update time : 2025-04-17
cytotoxicity testing: According to the testing methods required by ISO 10993-5, there are four types: "MTT method / agar method / membrane method / direct contact method." However, USP 87 only mentions three: "agar method / direct contact method / elution method." Does this mean that when entering the FDA market, only methods that simultaneously meet both ISO standards and USP requirements are allowed? Is the MTT method or membrane method not permitted?
Answer:
There is no need to meet both standards simultaneously; it is not related to USP. You just need to follow ISO 10993 guidelines for execution.
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