European legislation of biomedical technology.
The primary objectives which the European directive proposal wants to reach are: a) to guarantee a high quality standard of the products which are put into the EC market, for the user; b) to guarantee the safety and health of the user and of all other people who come into direct contact with the said products. The directives define a precise scheme of regulation and control for all medical devices and this scheme is in force for all the member states of European Union.
Mambretti
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Assobiomedica, Milan, Italy.
D004864:Equipment and Supplies / Q000592:standards; D005060:Europe; D005062:European Union; D013677:Medical Laboratory Science / Q000145:classification / Q000295:instrumentation / Q000331:legislation & jurisprudence* / Q000592:standards