ISO 10993-1:2003 Historical

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

standard by International Organization for Standardization , 08/01/2003

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Full Description

ISO 10993-1:2003 describes

  1. the general principles governing the biological evaluation of medical devices;
  2. the categorization of devices based on the nature and duration of their contact with the body;
  3. the selection of appropriate tests.

It 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.

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Document History

  1. ISO 10993-1:2025


    Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

    • Most Recent

  2. ISO 10993-1:2018


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

    • Historical Version

  3. ISO 10993-1:2009


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

    • Historical Version

  4. ISO 10993-1:2003

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

    • Historical Version

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Product Details

Published:

08/01/2003

Number of Pages:

14

File Size:

1 file

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus