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About This Item

 

Full Description

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.

All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 10993-11:2018


    Biological evaluation of medical devices - Tests for systemic toxicity

    • Most Recent
  2. BS EN ISO 10993-11:2018


    Biological evaluation of medical devices - Tests for systemic toxicity

    • Historical Version
  3. BS EN ISO 10993-11:2009


    Biological evaluation of medical devices-Tests for systemic toxicity

    • Historical Version
  4. BS EN ISO 10993-11:2006


    Biological evaluation of medical devices-Tests for systemic toxicity

    • Historical Version
  5. BS EN ISO 10993-11:1996


    Biological evaluation of medical devices-Tests for systemic toxicity

    • Historical Version
  6. BS 5736-5:1982


    Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices

    • Historical Version
  7. BS 5736-3:1981

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    Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices

    • Historical Version