BS EN ISO 10993-1:June 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices Evaluation and testing
Hardcopy , PDF
31-01-2017
English
30-04-2010
This part of ISO 10993 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. 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. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
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