| 医用诊断X射线机风险分析及讨论 |
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| 引用本文： | 黄嘉华.医用诊断X射线机风险分析及讨论[J].中国医疗器械杂志,2003,27(2):128-132. |
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| 作者姓名： | 黄嘉华 |
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| 作者单位： | 上海市药品和医疗器械审评中心,上海,200052 |
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| 摘 要： | 医疗器械是一种特殊的产品，安全性是医疗器械特殊性的具体体现。控制医疗器械产品安全性的方法除了执行相应的国际标准、国家标准和行业标准外．还必须用风险分析的方法贯穿产品开发的全过程。以医用诊断X射线机为例，说明医疗器械产品如何进行风险分析的方法．并展开有关讨论。
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| 关 键 词： | 医用诊断X射线机 风险分析 特征量判定 能量危害 环境危害 使用危害 发生概率 严重程度 风险评审 |
| 文章编号： | 1671-7104(2003)02-0128-05 |
| 修稿时间： | 2002年12月29 |
A Risk Analysis and Discussion about Diagnostic X-Ray Equipments |
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| HUANG Jia-hua,Shanghai Drug and Medical Device Evaluation Center.A Risk Analysis and Discussion about Diagnostic X-Ray Equipments[J].Chinese Journal of Medical Instrumentation,2003,27(2):128-132. |
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| Authors: | HUANG Jia-hua Shanghai Drug and Medical Device Evaluation Center |
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| Institution: | HUANG Jia-hua
Shanghai Drug and Medical Device Evaluation Center |
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| Abstract: | A medical device is a special product, and the reflection of its specialization is safety. Apart from the conformity to the relevant international, national and trade standards, risk analysis must be used in controlling the safety of medical devices all through the process of developing products. This article states how to analyze the risk of medical devices by illustrating it with the diagnostic x-ray equipment as an example. |
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| Keywords: | harm hazard risk |
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