BSI BS EN ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing
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BSI BS EN ISO 10993-1 Document Information:
Title
Biological evaluation of medical devices Part 1: Evaluation and testing
Biologische Beurteilung von Medizinprodukten. Beurteilung und Pruefungen
Evaluation biologique des dispositifs medicaux. Evaluation et essais
British Standards Institution
Publication Date:
Oct 9, 2003
Scope:
This part of ISO 10993 describes
a) the general principles governing the biological evaluation of medical devices;
b) the categorization of devices based on the nature and duration of their contact with the body;
c) 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).
Keywords:
- Medical equipment
- Biological analysis and testing
- Medical instruments
- Medical technology
- Biological hazards
- Dental equipment
- Dental materials
- Implants (surgical)
- Therapeutics
- Clinical investigation instruments
- Bioassay
- Cytotoxicity tests
- Contaminants
- Compatibility
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