Medical Devices
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Medical Devices - Quality Management Systems, Risk Management and Terminology
The European Medical Device Directive (93/42/EEC), states a medical device is:
"any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological process
- Control of conception.
. . . and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means . . .".
Key Publications:
BS EN ISO 22442-1:2007 Medical Devices Utilizing Animal Tissues and their Derivatives. Application of Risk Management
- Published: 29 Feb 2008
- ISBN: 9780580541872
- Price: £174.00
BS EN ISO 13485:2003 Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
- Published: 24 Jul 2003
- ISBN: 9780580686689
- Price: £204.00
Graphical Symbols for Use in the Labelling of Medical Devices CD-ROM
- Published: 05 Feb 2009
- ISBN: 9780580509797
- Price: £157.00
BS EN 980:2008 Symbols for Use in the Labelling of Medical Devices
- Published: 30 Jun 2008
- ISBN: 9780580546365
- Price: £156.00
BS EN 1041:2008 Information Supplied by the Manufacturer of Medical Devices
- Published: 29 Aug 2008
- ISBN: 9780580546617
- Price: £140.00
BS EN 55011:2009+A1:2010 Industrial, Scientific and Medical Equipment. Radio-frequency Disturbance Characteristics. Limits and Methods of Measurement
- Published: 31 Jan 2010
- ISBN: 9780580628290
- Price: £238.00
BS EN ISO 10993-1:October 2009 Biological Evaluation of Medical Devices. Evaluation and Testing within a Risk Management Process
- Published: 30 Jun 2010
- ISBN: 9780580716362
- Price: £158.00
BSI British Standards also publishes Standards on:
- In vitro medical devices
- Packaging for medical devices products and healthcare
- Sterilization of medical devices and packaging.
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