ISO 10993-11:2017

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ISO 10993-11:2017 is an international standard that specifies requirements and guidance for evaluating the potential for medical device materials to cause systemic toxicity. It's part of the ISO 10993 series, which focuses on biological evaluation of medical devices. Specifically, ISO 10993-11 deals with tests that assess the potential for materials to induce adverse effects in the body as a whole, rather than localized effects.