[Certification of medical devices].
The importance and peculiarities of certification of medical devices are analysed. The attention is focused on classification of devices which are potentially risky in application. The application aspects of the EU 93/42 Directive, i.e. a fundamental document in design, elaboration, production, sale and maintenance of medical devices are detailed.
Mashkov
A V
AV
Golikov
V A
VA
D002568:Certification / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000592:standards; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D012015:Reference Standards; D012426:Russia