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About This Item

 

Full Description

This document specifies:

— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.

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

Document History

  1. BS EN ISO 10993-1:2020

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    Biological evaluation of medical devices

    • Most Recent
  2. BS EN ISO 10993-1:OCTOBER 2009


    Biological evaluation of medical devices

    • Historical Version
  3. BS EN ISO 10993-1:2009


    Biological evaluation of medical devices

    • Historical Version
  4. BS EN ISO 10993-1:JUNE 2009


    Biological evaluation of medical devices. Evaluation and testing

    • Historical Version
  5. BS EN ISO 10993-1 Draft


    Biological evaluation of medical devices. Evaluation and testing within a risk management process

    • Historical Version
  6. BS 06/30106186 DC


    ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management system

    • Historical Version
  7. BS EN ISO 10993-1:2003


    Biological evaluation of medical devices

    • Historical Version
  8. BS EN ISO 10993-1:1998


    Biological evaluation of medical devices. Evaluation and testing

    • Historical Version