The preservation of the CE mark for a medical device further to a maintenance process

Author

Pecchia, Leandro ; Carpino, Giorgio ; Mirarchi, Luciano ; Bracale, Marcello

Author_Institution

Dept. of Biomed., Electron. & Telecommun. Eng., Univ. of Naples Federico II, Naples, Italy

fYear

2009

fDate

4-7 Nov. 2009

Firstpage

1

Lastpage

4

Abstract

In this paper we analyze the conditions for the preservation of the CE mark of a medical device further to maintenance process, especially in the case in which the maintenance is managed by a third company. Analyzing the European Directives on medical devices, we observed that the conditions, in which the manufacturer obtained the CE mark, might change when another company manages maintenance. We propose three solutions to face this situation.

Keywords

biomedical engineering; biomedical equipment; biomedical ultrasonics; consumer protection; maintenance engineering; CE mark preservation; European Directives; maintenance process; medical devices; Biomedical engineering; Biomedical imaging; Consumer electronics; Educational technology; Health and safety; Hospitals; Information technology; Manufacturing; Safety devices; Ultrasonic imaging; CE mark; HTA; maintenance;

fLanguage

English

Publisher

ieee

Conference_Titel

Information Technology and Applications in Biomedicine, 2009. ITAB 2009. 9th International Conference on

Conference_Location

Larnaca

Print_ISBN

978-1-4244-5379-5

Electronic_ISBN

978-1-4244-5379-5

Type

conf

DOI

10.1109/ITAB.2009.5394342

Filename

5394342