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This Document Has Been Superseded
A newer publication replaces it: BSI BS EN ISO 10993-11
Evaluation of medical devices for biological hazards -- Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
Withdrawn
Describes the method of test designed to provide information on the acute toxic effects attributable to leachable inherent or extraneous substances present in or on a medical device using a polar and non-polar solvent to obtain extracts that are administered as a parenteral dose to mice.
Use with the guidance of Part 1.
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