正交实验设计在医疗器械设计和开发过程中的应用

Orthogonal Experimental Design in Medical Device Design and Development Process

正交试验设计是一种应用普遍的试验工具,在多行业得到了广泛的应用,但在医疗器械行业却较少见到相关的报道。文章介绍正交试验设计在医疗器械产品开发过程中医用导管尖端成型工艺中的应用,通过应用正交试验设计中极差分析和方差分析方法,确定对医用导管尖端黏接力影响的关键因子,并确定温度、推力、时间和材料种类对医用导管尖端黏接力的影响,验证并确定最佳的医用导管尖端成型工艺参数窗口。

Orthogonal design of experiment is a kind of application of common test tools,and it has been widely used in many industry,but in the medical device industry is less seen.This paper introduces the application of orthogonal test design in the process of the development of medical device products,the application of catheter tip.By applying the method of extreme difference analysis and variance analysis in orthogonal test design,The key factors affecting the adhesion of the catheter tip are determined.The influence of temperature,thrust,time and material type on the adhesive force of the tip of the medical catheter was determined.The optimum parameters of the tip shape of medical catheter were confirmed and confirmed.