ISO 10993-1:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices Part 1: Evaluation and testing
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
11-28-2018
English, French
07-28-2003
ISO 10993-1:2003 describes
- the general principles governing the biological evaluation of medical devices;
- the categorization of devices based on the nature and duration of their contact with the body;
- 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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