摘要
产品性能指标是检验产品质量的关键,科学合理的性能指标能够有效管控产品质量。目前激光选区熔化定制式义齿无对应的国行标准及指导原则,各省对产品性能指标的要求不尽相同。孔隙作为激光选区熔化成型件的常见缺陷,是评估产品质量的关键指标。文章介绍了孔隙缺陷的类型,孔隙率的影响因素,孔隙率与密度、力学性能的相关性等内容,旨在分析孔隙率作为激光选区熔化定制式义齿产品性能指标的必要性,为生产企业和监管人员提供参考。
The performance index is crucial for assessing product quality.A scientifically and logically designed performance index can effectively regulate and control the quality of products.At present,there is no corresponding national standard,industry standard and guideline for custom dentures using selective laser melting.The performance index of product in different provinces are different.As a common defect of samples using selective laser melting,porosity is a key index to evaluate product quality.By investigating pore types,the influence factors of porosity,the correlation between porosity and density,as well as the relationship between porosity and mechanical properties,this study analyzes the necessity of establishing a performance index for custom dentures using selective laser melting,providing valuable insights for manufacturers and supervisors.
作者
丘婧婷
张龙瑛
沈晓华
QIU Jing-ting;ZHANG Long-ying;SHEN Xiao-hua(Fujian Center for Drug Evaluation and Monitoring,Fujian Fuzhou 350003)
出处
《中国医疗器械信息》
2024年第9期20-22,共3页
China Medical Device Information
基金
福建省药品监督管理局(项目名称:3D打印定制式义齿注册审评指导原则研究,项目编号:2022013)。
关键词
孔隙率
激光选区熔化
定制式义齿
性能指标
porosity
selective laser melting
custom denture
performance index