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| 关于规范数字乳腺X线摄影系统注册产品标准的探讨 | |
| 引用本文： | 张宇晶,刘志成,孙智勇. 关于规范数字乳腺X线摄影系统注册产品标准的探讨[J]. 中国医疗器械杂志, 2012, 36(2): 125-7, 148 |
| 作者姓名： | 张宇晶 刘志成 孙智勇 |
| 作者单位： | 1. 首都医科大学生物医学工程学院,北京,100069;国家食品药品监督管理局医疗器械技术审评中心,北京,100044 2. 首都医科大学生物医学工程学院,北京,100069 3. 辽宁省医疗器械检验所,沈阳,110179 |
| 摘 要： | 通过对数字化乳腺X线摄影系统注册产品标准及行业标准制定时应侧重考虑的问题进行探讨,提出在未来的标准制定中,不但要从设备结构特点本身来考量和选择需要规范的技术指标,同时也要从临床使用风险的角度,来增加相应技术要求。 |
| 关 键 词： | 注册产品标准 数字乳腺X线摄影系统 |
Normalize product registration standard of digital mammography system |
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| Zhang Yujing , Liu Zhicheng , Sun Zhiyong. Normalize product registration standard of digital mammography system[J]. Chinese journal of medical instrumentation, 2012, 36(2): 125-7, 148 | |
| Authors: | Zhang Yujing Liu Zhicheng Sun Zhiyong |
| Affiliation: | Biomedical Engineering Institute, Capital Medical University, Beijing 100069. |
| Abstract: | This paper aims to discuss the issues needed to be considered during the process of defining the registered product standards and industry standards of digital mammographic X-ray camera system. Meanwhile, for the future reference of establishment of standards, it adds the additional technical requirements not only from the features of device's structure, but also from the risk of clinical use. |
| Keywords: | product registration standard digital mammography system |
| 本文献已被 CNKI 万方数据 PubMed 等数据库收录！ | |