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ISO 10993-1:2003

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

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.

Content Provider
International Organization for Standardization [iso]

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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.