| 医疗器械注册产品标准常见问题分析 |
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| 引用本文： | 余冬,李根池. 医疗器械注册产品标准常见问题分析[J]. 中国医疗器械杂志, 2012, 36(1): 61-63 |
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| 作者姓名： | 余冬 李根池 |
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| 作者单位： | 河南省医疗器械检验所,郑州,450003 |
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| 摘 要： | 医疗器械注册产品标准是企业生产和监督检查依据的重要技术文件。目前注册产品标准中还存在一些问题,该文根据标准编写规范对常见问题进行分析。
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| 关 键 词： | 医疗器械 注册产品标准 规范性文件 |
Analysis for the common problems of the product standards for medical devices' registeration |
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| Yu Dong , Li Genchi. Analysis for the common problems of the product standards for medical devices' registeration[J]. Chinese journal of medical instrumentation, 2012, 36(1): 61-63 |
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| Authors: | Yu Dong Li Genchi |
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| Affiliation: | Henan Medical Instrument Testing Institute,Zhengzhou,450003 |
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| Abstract: | The product standards for medical devices’registration are important technical document for production and supervision. Up to now,some problems still exist in these product standards.This paper analyzes common issues according to the standard writing specifications. |
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| Keywords: | medical device registration product standard normative document |
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