| 关于YY 0068.1-2008中条款4.6的理解与检测方法探讨 |
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| 引用本文： | 黄德球,樊翔,黄志强,丁罕,王海娟.关于YY 0068.1-2008中条款4.6的理解与检测方法探讨[J].中国医疗器械信息,2013(8):28-30. |
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| 作者姓名： | 黄德球 樊翔 黄志强 丁罕 王海娟 |
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| 作者单位： | 国家食品药品监督管理局广州医疗器械质量监督检验中心,广州510663 |
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| 摘 要： | 条款4.6"综合光效"作为标准YY 0068.1-2008的新增要求,对保证内窥镜的成像质量和成像安全都具有很重要的指导意义。本文就条款4.6的内容和检测方法进行梳理和诠释,以期对生产厂商和相关检测人员更好地理解该条款提供一定的帮助。
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| 关 键 词： | 内窥镜 综合镜体光效 综合边缘光效 |
Discussions about Comprehension and Test Methods of 4.6 in YY 0068.1-2008 |
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| HUANG De-qiu,FAN Xiang,HUANG Zhi-qiang,DING Han,WANG Hai-juan.Discussions about Comprehension and Test Methods of 4.6 in YY 0068.1-2008[J].China Medical Devices Information,2013(8):28-30. |
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| Authors: | HUANG De-qiu FAN Xiang HUANG Zhi-qiang DING Han WANG Hai-juan |
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| Institution: | HUANG De-qiu FAN Xiang HUANG Zhi-qiang DING Han WANG Hal-juan State Food and Drug Administration Supervision and Testing Center for Medical Devices of Guangzhou. (Guangzhou 510663) |
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| Abstract: | ＂synthetical relative effect of light energy＂ in YY 0068.1-2008, a newly additional item for this occupation standard, helped to ensure the image quality and safety of the endoscope. This article analyzed requirements of 4.6, furthermore, given suggested testing process. It will help the manufactures to comprehend the item better. |
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| Keywords: | endoscope syntheticalrelativeself-effectoflightenergy synthetical relative effect ofedge light energy |
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