YY0875-2013直线型吻合器(物理部分)检测与临床风险的讨论  

YY0875-2013 Discussion on Detection and Clinical Risk of Linear Stapler(Physical Part)

作　　者：张泽鑫 ZHANG Ze-xin(Jiangsu Institute for Medical Device Inspection,Jiangsu Nanjing 210019)

机构地区：[1]江苏省医疗器械检验所,江苏南京210019

出　　处：《中国医疗器械信息》2024年第1期35-38,125,共5页China Medical Device Information

摘　　要：参照直线型吻合器行业标准YY0875-2013规定的物理检测要求和试验方法,对常见的一次性使用直线型吻合器物理性能进行检测分析,并对检验结果出现的问题结合临床使用可能出现的风险进行分析,以期对规范一次性使用直线型吻合器市场和提高其产品质量有所帮助。According to the physical testing requirements and test methods specified in the linear stapler industry standard YY0875-2013,the physical properties of common disposable linear staplers were tested and analyzed,and the problems arising from the test results were analyzed in combination with the possible risks arising from clinical use.It is helpful to standardize the disposable linear stapler market and improve its product quality.

关 键 词：直线型吻合器 物理性能 临床风险 

分 类 号：TH779[机械工程—仪器科学与技术]