Risk analysis and implants
| Autor: | J.I. Alava, E. Ipiñazar, I. Braceras, M.A. De Maeztu |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Risk analysis
Prosthesis-Related Infections medicine.medical_treatment Biomedical Engineering Biophysics Dentistry Risk Assessment Osseointegration Dental Prosthesis Retention Risk Factors Product Surveillance Postmarketing Medicine Humans Dental implant Periodontitis Risk management Proportional Hazards Models Dental Implants business.industry Proportional hazards model Incidence Clinical trial Treatment Outcome Risk analysis (engineering) Spain business Risk assessment |
| Zdroj: | Medical engineeringphysics. 30(9) |
| ISSN: | 1350-4533 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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