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国家药监局发布11项牙科医疗器械行业标准

 
Issuing time:2025-06-26 12:30Author:编辑部
好的牙·讯｜国家药品监督管理局近日发布2025年第59号公告，正式公布38项医疗器械行业标准已经审定通过。附件显示，共有11项牙科学医疗器械行业标准，其中4项为修订标准，7项为制定标准。 在修订标准中，人工牙产品标准更新了合成树脂牙与陶瓷牙的分类及试验要求；牙科修复体材料的热力学匹配性评估标准整合了此前分散的多项规范，并强调仅适用于组合材料；聚合物基牙冠和贴面材料标准扩充了适用场景；金属材料腐蚀试验方法则优化了检测流程。

7项制定的标准填补了多项技术空白，包括：针对非永久性医疗环境中的可携带牙科设备提出通用技术要求；新增口腔数字化X射线成像系统、外科手术刀柄、反角充填器、软组织环切刀、多功能喷枪及种植手术用环钻等产品的专项规范。


新标准对适用范围作出精细界定。例如口腔数字化X射线成像系统标准明确限定于单次曝光的数字化探测设备，排除传统胶片成像及口外设备；修复体材料匹配性标准特别指出单一材料不可声称符合要求。


（本内容图源：国家药监局官网）


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