BSI BS EN ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing
 |
| Purchase Information |
| Use this form to request purchase information on BSI online subscriptions. |
|
|
Document BSI BS EN ISO 10993-1 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.
You may also purchase this document alone from the IHS Standards Store.
BSI BS EN ISO 10993-1 Document Information:
Title
Biological evaluation of medical devices Part 1: Evaluation and testing
British Standards Institution
Publication Date:
Jul 31, 2009
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
About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.
