ISO 10993-3 specifies strategies for risk estimation, selection of hazard identification tests and risk management in relation to the probability of the following potentially irreversible biological effects as a result of exposure to medical devices.
ISO 10993-3 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity or reproductive toxicity has been determined.
ISO 10993-1 and chemical characterization of materials should be considered before a decision is made to perform a genotoxicity test. The rationale for a testing program should be documented, taking into account all relevant factors.
However, genotoxicity testing is not required for medical devices and their components made only from materials known to be non-genotoxic. Genotoxicity testing is indicated when a review of the composition of materials reveals the possible presence of compounds in the final medical device that may interact with the genetic material, or where the chemical composition of the medical device is unknown.
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