According to the European Medical Device Directive (93/42/EEC), 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 . . ."
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BSI British Standards also publishes standards on:
BS EN ISO 14971 is an international standard for manufacturers of medical devices. It specifies a process through which the manufacturer can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control.
This international standard deals with the processes for managing risks to the patient, the operator and other people, to other equipment and to the environment.
 BS EN 15424:2007
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 14971:2007
Medical devices. Application of risk management to medical devices |
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 BS EN 980 CD-ROM
BS EN 980:2008 Symbols
for use in the labelling of
medical devices CD-ROM |
BS EN 980:2008
Symbols for use in the labelling of medical devices |
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