RT Journal Article
T1 Risk analysis and implants
A1 Braceras, I.
A1 Ipiñazar, E.
A1 De Maeztu, M. A.
A1 Alava, J. I.
AB According to the Medical Devices Directive, both the preparation for clinical trials and marketing of implants require that a risk analysis is performed. This paper presents a risk analysis for a dental implant in the framework of the risk management process carried out for the preparation of a multi-centre clinical trial, where likely hazards, failure modes and their severities, probabilities and detectabilities are assessed, together with a review of the related scientific literature. The clinical study aimed to evaluate a new ion implantation-based implant surface designed for the promotion of more extensive and faster osseointegration.
SN 1350-4533
YR 2008
FD 2008-11
LK https://hdl.handle.net/11556/4336
UL https://hdl.handle.net/11556/4336
LA eng
NO Braceras , I , Ipiñazar , E , De Maeztu , M A & Alava , J I 2008 , ' Risk analysis and implants ' , Medical Engineering and Physics , vol. 30 , no. 9 , pp. 1201-1204 . https://doi.org/10.1016/j.medengphy.2008.04.001
DS TECNALIA Publications
RD 26 jul 2024