RESUMO
For implantable medical devices, traditional mechanical property testing is achieved by mechanical testing devices, while such method is lack of pertinence during sampling of series of products, and also time consuming during experimental testing. With the complete development of finite element analysis (FEA) techniques, introducing FEA to quality supervision and inspection will become a scientific method for saving resources and time, and also improve the pertinence. In this study, the creditability of FEA in application of highest risk sample selection, failure analysis of marketed products and auxiliary optimization of fatigue test testing was verified through case study and experimental testing. The feasibility of FEA during implants inspection was illustrated. In order to ensure the accuracy and reliability of FEA in the application of implants inspection, the essentials of establishing related finite element standards were proposed.
RESUMO
This paper expounds the statistical work on artificial joint failure and their primary results in China and abroad. From the view of clinical demand, biomechanics and engineering, the paper proposes that it is the basic technology, manufacturing techniques and clinical conditions that lead to artificial joint failure. The paper also elaborates the demand on further improving the clinical medicine of artificial joint and prosthesis technology, and presents some suggestions to promote the domestic statistics work on artificial joint failure.
RESUMO
This article makes a pilot study on the key points of the quality management system of in-vitro diagnostic reagents by analyzing the technical characteristics and production methods of these products as well as the status in quo, and problems the in-vitro diagnostic reagent industry in China is facing nowadays. It can serve as a reference to the supervision departments and the manufacturers in this field which are establishing and running the quality management system.
Assuntos
Humanos , China , Equipamentos e Provisões , Padrões de Referência , Indicadores e Reagentes , Química , Padrões de Referência , Projetos Piloto , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade , Kit de Reagentes para Diagnóstico , Padrões de Referência , Gestão da Segurança , Tecnologia Farmacêutica , Padrões de Referência , Gestão da Qualidade TotalRESUMO
This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.