Title :
European directives and technical standards for medical equipment
Author_Institution :
Dept. of Biomed. Eng., Polytech. Univ., Milan, Italy
fDate :
31 Oct-3 Nov 1996
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;
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
DOI :
10.1109/IEMBS.1996.646493
