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内窥镜设备安全性评价在新旧标准中的差异要点解读

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目的 分析内窥镜设备安全性评价在新旧标准中的差异,促进内窥镜设备的质量控制.方法 结合内窥镜设备的工作原理、结构特征和主要功能,分别从电气安全通用标准和电气安全专用标准方面总结标准差异的要点,对内窥镜设备的设计开发提出合理化建议.结果 内窥镜设备安全性评价在新旧标准中的主要差异体现在基本性能、超温、防火外壳、清洗、消毒、灭菌、应用部分、辐射安全、高频互连风险等方面.结论 通过对内窥镜设备安全性评价在新旧标准中的差异要点进行分析,为此类产品的设计开发提供一定的思路,为产品质量评价体系的完善提供参考.
Key Points of Difference Between Old and New Standards in the Safety Evaluation of Endoscope Equipment
Objective To analyze the differences between the old and new standards in the safety evaluation of endoscope equipment,so as to promote its quality control.Methods Based on the working principle,structural features and main functions of endoscope equipment,the key points of difference in standards were summarized from both general and specific electrical safety standards.Some rational suggestions were put forward for the design and development of endoscope equipment.Results The main differences in safety evaluation of endoscope equipment between old and new standards were reflected in aspects such as basic safety,over-temperature protection,fire enclosure,cleaning,disinfection,sterilization,applied part,radiation safety,and the risk of interconnect with high-frequency equipment.Conclusion By analyzing the key points of the difference between the old and new standards in the safety evaluation of endoscope equipment,certain ideas are provided for the design and development of such products,and a reference is provided for the improvement of product quality evaluation system.

endoscopic equipmentsafetyevaluationdifference in standards

蒋硕、万敏、李庆雨、裴晓娟、张在爱、冯乐菲、陈一依、张克

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山东省医疗器械和药品包装检验研究院,山东 济南 250101

国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,山东 济南 250101

内窥镜设备 安全性 评价 标准差异

山东省重点研发计划(重大科技创新工程)项目山东省医疗器械和药品包装检验研究院内部科研课题

2022CXGC010502NB202208

2024

中国医疗设备
中国整形美容协会

中国医疗设备

CSTPCD
影响因子:0.825
ISSN:1674-1633
年,卷(期):2024.39(3)
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