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

This part of ISO 10993 describes a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of contact with the body; c) the selection of appropriate tests. ISO 10993 does not cover testing of materials and devices that do not come into contact with the patient's body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.