The ISO set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. The following table provides a framework for the development of a biocompatibility evaluation. Different biological endpoints may require evaluation for particular medical devices, including either additional or fewer endpoints than indicated. If it is unclear in which category a device falls, consulting device-specific guidances or contacting the appropriate US Food and Drug Administration FDA review division for more information is possible.
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ISO specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:. ISO is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established. Check out our FAQs. Buy this standard. This standard contributes to the following Sustainable Development Goal :.