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NS-EN ISO 10993-1:1997

Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:1997)

standard by Standards Norway NS-EN ISO , 03/25/1998

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Full Description

This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests. 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 os ISO 10993 cover specific tests as indicated in the foreword. (See also the rationale in A.2.)
 

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Published:
03/25/1998
Number of Pages:
20
 

Document History

  1. NS-EN ISO 10993-1:2020


    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018)

    • Most Recent

  2. NS-EN ISO 10993-1:2009/AC:2010


    Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1 (ISO 10993-1:2009/Cor 1:2010)

    • Historical Version

  3. NS-EN ISO 10993-1:2009


    Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

    • Historical Version

  4. NS-EN ISO 10993-1:2003


    Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003)

    • Historical Version

  5. NS-EN ISO 10993-1:1997

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    Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:1997)

    • Historical Version