摘要
开展医疗器械产品硬度检测的不同试验方法分析,阐述并掌握其试验要点及产品适用范围,为医疗器械的科学有效检测提供依据;同时,对比不同硬度试验方法的原理和应用,为医疗器械产品硬度性能评价、硬度测试方法提供参考。
Different test methods of hardness for medical device are studied. The essentials and applicable area of test methods for the medical products are stated, in order to provide the basis of test methods for fair and effective detection of medical devices. Meanwhile, principle and application of different hardness test methods are compared, which gives the reference for the performance evaluation and selection of hardness test method for medical devices.
作者
黄军辉
胡洁峰
肖昌豪
胡晓亮
HUANG Jun-hui;HU Jie-feng;XIAO Chang-hao;HU Xiao-liang(Hangzhou Center for Medical Device Quality Supervision and Testing of CFDA （Zhejiang Hangzhou 310009)
出处
《中国医疗器械信息》
2018年第9期22-24,共3页
China Medical Device Information
基金
浙江省食品药品监督管理局科技计划项目(项目编号:2018021)
关键词
医疗器械
硬度
试验方法
medical device
hardness
test method
