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中国医疗器械杂志 2019, Vol. 43 Issue (5) :365-368    DOI: 10.3969/j.issn.1671-7104.2019.05.015
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PET/MR生产环节风险分析及对现场检查的建议
杨义强,刘歆,钱虹
上海市食品药品监督管理局认证审评中心,上海市,200020
Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection
YANG Yiqiang, LIU Xin, QIAN Hong
Center for Certification & Evaluation, SHFDA, Shanghai, 200020

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摘要 PET/MR一体机是集PET和MR设备为一体的、高度复杂的、具有丰富临床功能以及分子诊断功能的高端医疗影像设备, 可获得人体有关结构、功能和代谢等方面的全方位信息,对于改进疾病的诊断和治疗具有重要价值。该文通过对PET/MR 产品全生命周期主要阶段之一的生产环节中的风险要点分析,结合医疗器械生产质量管理规范,探索性地提出了对PET/ MR生产企业进行生产质量管理体系现场检查的一些建议,对于PET/MR产品现场体系核查过程中明确产品生产环节的风 险点 ,提高核查效率具有一定意义。
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关键词PET/MR   风险防控   质量管理规范   现场检查     
Abstract: PET/MR is a high-end medical imaging equipment with integrating PET and MR equipment into the highly sophisticated one and has rich clinical and molecular diagnosis functions, can obtain comprehensive information about the human body structure, function and metabolism, is of great value for the diagnosis and treatment of disease improvement. In this paper, through the analysis of existing production risk points on one of the primary stages of the whole product life cycle, combining with the medical device good manufacture practice, some suggestions have been put forward exploratively to field inspection for PET/MR manufacturers. It has certain significance for regulators of medical devices to clear the production risk point and improve verification efficiency during field inspection.
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Received 2019-05-20;
Fund:

上海市科委“科技创新行动计划”技术标准项目(16DZ0503700)

Corresponding Authors: 刘歆     Email: liuxin@smda.sh.cn
About author: 杨义强,E-mail: yangyiqiang@smda.sh.cn
引用本文:   
杨义强,刘歆,钱虹.PET/MR生产环节风险分析及对现场检查的建议[J]  中国医疗器械杂志, 2019,V43(5): 365-368
YANG Yiqiang, LIU Xin, QIAN Hong.Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection[J]  Chinese Journal of Medical Instrumentation, 2019,V43(5): 365-368
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