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About This Item

 

Full Description

Method specifies measurement of the rise in body temperature of rabbits during a period of 3 hours following an intravenous injection of an extract of the device prepared with pyrogen-free saline. Method intended to identify the presence of pyrogenic materials in, or on, a medical device.

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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

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    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


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

    • Historical Version