European directives and technical standards for medical equipment

Author

Cerutti, Sergio

Author_Institution

Dept. of Biomed. Eng., Polytech. Univ., Milan, Italy

Volume

5

fYear

1996

fDate

31 Oct-3 Nov 1996

Firstpage

2194

Abstract

Inside European Union (EU) nations a consensus has been reached in order to obtain precise rules for the regulatory and standards definitions of medical equipment and devices. Such a decision has created a certain number of procedures to be fulfilled by manufacturers, political authorities, notified bodies, clinical engineering departments and others in a very important qualitative and quantitative market like Europe is. Some fundamental steps in this very complex approach of regulatory affairs are described in this paper

Keywords

biomedical equipment; legislation; standards; European Union nations; European directives; clinical engineering departments; manufacturers; medical equipment; notified bodies; political authorities; precise rules; regulatory affairs; technical standards; Biomedical engineering; Biomedical equipment; Clinical diagnosis; Europe; IEC standards; Manufacturing industries; Manufacturing processes; Medical diagnostic imaging; Standards development; Standards publication;

fLanguage

English

Publisher

ieee

Conference_Titel

Engineering in Medicine and Biology Society, 1996. Bridging Disciplines for Biomedicine. Proceedings of the 18th Annual International Conference of the IEEE

Conference_Location

Amsterdam

Print_ISBN

0-7803-3811-1

Type

conf

DOI

10.1109/IEMBS.1996.646493

Filename

646493