一种国产手术显微镜实际应用综合评价

Comprehensive Evaluation of the Practical Application of a Domestic Surgical Microscope

目的对国产某品牌ASOM-4型手术显微镜进行上市后再评价。方法按照国标GB 9706.1-2007和GB 11239.1-2005要求,将国产手术显微镜与国外同类产品进行比较,除产品准入评价外,着重于评价可靠性、操作性、经济性和售后服务。结果该型国产手术显微镜能达到相关行业标准要求,可靠性、操作性和售后服务能满足临床需求,同时经济性好。结论该国产手术显微镜在多种显微手术中均有效可用,且较进口产品更为经济,是值得推荐的国产先进医疗器械。

Objective To perform the post-marketed re-evaluation of a domestic ASOM-4 operation microscope.Methods According to the requirements of GB 9706.1-2007 and GB 11239.1-2005,domestic surgical microscopes were compared with the similar foreign products.In addition to product admittance evaluation,it focused on evaluating reliability,operability,economy and after-sales service.Results This type of domestic operating microscope could meet the requirements of relevant industry standards.Its reliability,operability and after-sales service could meet the clinical needs,and it was economical at the same time.Conclusion This domestic operating microscope is available in many kinds of microsurgery,and it is more economical than the imported products.It is an advanced medical instrument worthy of recommendation.