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About This Item

 

Full Description

This part of ISO 10993 describes:
  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of 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.


This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.
 

Document History

  1. ISO 10993-1:2018


    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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  2. ISO 10993-1:2009

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    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

    • Historical Version
  3. ISO 10993-1:2003


    Biological evaluation of medical devices - Part 1: Evaluation and testing

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 10993-1/Cor1:2010

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    Biological evaluation of medical devices - Part 1: Guidance on selection of tests - Corrigendum