现行拔牙钳的国际、国内标准对比解析  

Comparison between international and domestic standards on dental extraction forceps

作　　者：宁锐剑[1] 胡相华[1] 袁秦[1] 陈贤明 陈宇恩[1] 吴伟荣[1] Ning Ruijian;Hu Xianghua;Yuan Qin;Chen Xianming;Chen Yu’en;Wu Weirong(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou 510063;Shinye Orthodontic Products Co.Ltd.,Hangzhou 310015)

机构地区：[1]广东省医疗器械质量监督检验所,广州510063 [2]浙江新亚医疗科技股份有限公司,杭州310015

出　　处：《口腔材料器械杂志》2023年第2期147-152,共6页Chinese Journal of Dental Materials and Devices

摘　　要：拔牙钳使用历史悠久、生产工艺成熟、临床应用普遍,是一种最基础的牙科手术用器械。为保证拔牙钳的安全、降低其伤害风险,全球很多国家都出台了拔牙钳的产品标准,国际标准化组织ISO也制定了拔牙钳的国际通用标准。该文将我国现行拔牙钳标准与国际通用标准进行逐条比较,结合拔牙钳的发展趋势进行分析,旨在为广大企业、监管部门、技术支撑机构和科研院所提供一份标准使用指南。Extraction forceps has a long history,mature production technology and widespread clinical application.It is the most basic dental surgical instrument.In order to ensure the safety of tooth extraction forceps and reduce the risk of harm,many countries around the world have issued product standards for extraction forceps,and the International Organization for Standardization(ISO)has also published the series international standards for extraction forceps.The current domestic standards of extraction forceps are compared with the series international standards one term by one term in combination with the trend analysis of the extraction forceps development.The aim is to provide a guide for the manufacturers,regulators,technical support organisations and research institutes.

关 键 词：拔牙钳 标准比较 

分 类 号：R782.11[医药卫生—口腔医学]