论文部分内容阅读
目的探析小型熔断器标识在医用电气设备中的重要作用。方法针对近年来医疗器械的国家监督抽验发现不合格问题主要集中在对GB 9706.1-2007标准中的6.1n)设备外部熔断器标识内容的理解上这一现象进行分析。介绍了熔断器的标识要求和选用,为熔断器的使用提供参考。结果医用电气设备在设计时,不仅要考虑GB9706.1的要求,还要考虑其他专用安全标准的要求,加强设备外部标识的正确性。结论生产企业在医用电气设备的设计和生产过程中应全面贯彻相关标准要求,尤其注重细节的控制和把握,使所生产出的医用电气设备真正做到安全、有效。
Objective To explore the important role of small fuse marking in medical electrical equipment. Methods According to the national supervision and inspection of medical devices in recent years, the unqualified problems are mainly concentrated on the understanding of the phenomenon of 6.1n) external fuse identification in GB 9706.1-2007 standard. Introduced the identification requirements and selection of fuses, providing reference for the use of fuses. Results Medical electrical equipment in the design, not only to consider the requirements of GB9706.1, but also consider the requirements of other special safety standards and strengthen the correctness of the external logo of the equipment. Conclusion The manufacturing enterprises should fully implement the relevant standards in the design and production of medical electrical equipment, paying particular attention to the control and grasping of the details so that the medical electrical equipment produced can be truly safe and effective.