Risk analysis and implants

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URI: https://hdl.handle.net/11556/4336
ISSN: 1350-4533
DOI: 10.1016/j.medengphy.2008.04.001
Publication date
2008-11
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Abstract
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.
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Clinical study , Dental implant , Ion implantation , Medical Device Directive , Risk analysis , Biophysics , Biomedical Engineering
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journal article
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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