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| 采用国际标准的医疗器械行业标准编写中需注意的若干问题 | |
| 引用本文： | 郑佳,余新华. 采用国际标准的医疗器械行业标准编写中需注意的若干问题[J]. 中国医疗器械杂志, 2012, 36(3): 215-217 |
| 作者姓名： | 郑佳 余新华 |
| 作者单位： | 中国食品药品检定研究院,北京,100050;国家食品药品监督管理局医疗器械标准管理中心,北京,100050 |
| 摘 要： | 总结了我国采用国际标准的医疗器械行业标准编写时存在的部分问题,并结合GB/T1.1-2009和GB/T20000.2-2009,对这类标准编写提出相应的意见和建议。 |
| 关 键 词： | 医疗器械 医疗器械标准 采用国际标准 |
Preliminary discussion on the preparation of medical device standards adopting international standards |
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| Zheng Jia , Yu Xinhua. Preliminary discussion on the preparation of medical device standards adopting international standards[J]. Chinese journal of medical instrumentation, 2012, 36(3): 215-217 | |
| Authors: | Zheng Jia Yu Xinhua |
| Affiliation: | National Institutes for Food and Drug Control, Beijing, 100050. |
| Abstract: | Conclude some specific problems in drafting the industry standards of medical devices which are adoptedto international standards. Provide relevant suggestion and recommendation in accordance to GB/T 1.1-2009 and GB/T 20000.2-2009, some preliminary suggestions were accordingly proposed. |
| Keywords: | medical device medical device standard adoption of international standards |
| 本文献已被 CNKI 万方数据 PubMed 等数据库收录！ | |