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DIN EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2009
This standard addresses the evaluation of generalized systemic toxicity, not specific target organ or organ system toxicity, even though these effects may result from the systemic absorption and distribution of toxicants. Because of the broad range of medical devices, and their materials and intended uses, this standard is not overly prescriptive. While it addresses specific methodological aspects to be considered in the design of systemic toxicity tests, proper study design must be uniquely tailored to the nature of the device's materials and its intended clinical application. Other elements of this standard are prescriptive in nature, including those aspects that address compliance with good laboratory practices and elements for inclusion in reporting.
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Deutsches Institut für Normung [din]