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医疗器械标准常见问题分析研究及建议
引用本文:赵挺,石莉,迟戈,梁文,马艳彬. 医疗器械标准常见问题分析研究及建议[J]. 中国医疗器械信息, 2022, 0(3): 17-19,23
作者姓名:赵挺  石莉  迟戈  梁文  马艳彬
作者单位:辽宁省检验检测认证中心认证审评院
摘    要:对我国某些医疗器械标准存在的多年不修订、性能指标不尽合理等问题进行分析研究,建议有关部门定期修订医疗器械标准特别是强制性标准,并加大通用性标准的制订力度.

关 键 词:医疗器械标准  强制性标准  技术要求

Analysis of Chinese Medical Device Standards and Suggestion
ZHAO Ting,SHI Li,CHI Ge,LIANG Wen,MA Yan-bin. Analysis of Chinese Medical Device Standards and Suggestion[J]. China Medical Devices Information, 2022, 0(3): 17-19,23
Authors:ZHAO Ting  SHI Li  CHI Ge  LIANG Wen  MA Yan-bin
Affiliation:(Liaoning Institute for Certification and Evaluation,LIECC,Liaoning Shenyang 110030)
Abstract:Analyzes and studies the problems of poor timeliness and unreasonable performance indicators in medical device standards.It is recommended that relevant departments periodically revise medical device standards,especially mandatory standards,and increase the formulation of universal standards.
Keywords:medical device standards  compulsory standards  technical requriement
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