Title :
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
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;
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
DOI :
10.1109/ITAB.2009.5394342
