摘要
目的从技术审评角度,研究全瓷义齿用氧化锆瓷块产品的安全性和有效性。方法基于各国行业标准和指南文件,对全瓷义齿用氧化锆瓷块产品从结构组成、工作原理、技术要求、风险分析、临床要求5个方面进行了分析研究。结论从技术审评角度,为保证产品的安全性和有效性,应加强对全瓷义齿用氧化锆瓷块的原材料和生产工艺的控制。
Objective To investigate the security and effectiveness of all-ceramic zirconia tiles from the perspective of technical evaluation. Methods Based on the relevant standards and guidance documents in this field from various countries and regions, the research was carded out focusing on the structure, principle, technical requirements, risk analysis and clinical trial of the all-ceramic zirconia tiles. Conclusion From the perspective of technical evaluation, the raw materials and production techniques of the all-ceramic zirconia tiles should be enhancedly controlled so as to ensure the security and effectiveness.
出处
《中国医疗设备》
2014年第2期77-79,共3页
China Medical Devices
关键词
全瓷义齿
氧化锆瓷块
固定义齿
技术审评
生产工艺
all-ceramic dentures
zirconia tiles
fixed dentures
technical evaluation
production techniques
