关于GB 9706.1-2020中手传振动检测方法的探讨OA
Discussion on Hand-transmitted Vibration Detection Method in GB 9706.1-2020
本文对医用电气(Medical Electrical,ME)设备在进行手传振动检测时需要参考的相关标准要求进行研究,提出由于国内方法标准存在整合度低、适用性不明确、过度滞后等问题导致试验开展困难.同时,就手传振动检测所需检测设备、传感器的安装、样品的布置等进行详细分析,指出按现行相关国家标准进行ME设备的手传振动检测时,由于多个时间跨越长度较大的方法标准未能很好地进行兼容,导致手传振动的检测环境复杂、难以实现.本文针对上诉问题提出了合理建议,以期可以提高医疗器械生产企业与相关检验检测机构的检验效率,保证检验检测的准确度.
This article explored the relevant standard requirements that need to be referenced when conducting hand-transmitted vibration tests on medical electrical(ME)equipment.It pointed out that the difficulties in conducting these tests arised from issues such as low integration,unclear applicability,and excessive lag in domestic method standards.The article also provided a detailed analysis of the testing equipment required for hand-transmitted vibration tests,sensor installation,and sample arrangement.It highlighted that when conducting hand-transmitted vibration tests on ME equipment according to then current relevant national standards,the complexity and difficulty of achieving a suitable testing environment were due to the lack of compatibility among multiple method standards with significant time spans.Finally,the article proposed reasonable suggestions aimed at improving the inspection efficiency of medical device manufacturers and relevant inspection and testing institutions,and ensuring the accuracy of inspection and testing.
邓翔文;强小龙
广西壮族自治区医疗器械检测中心 有源检测室,广西 南宁 530021广西壮族自治区医疗器械检测中心 有源检测室,广西 南宁 530021
医药卫生
医用电气设备手传振动传感器耦合力手臂振动病握力振动性白指振动频率
medical electrical equipmenthand-transmitted vibrationsensorcoupling forcehand-arm vibration diseasepower of grippingvibration-induced white fingervibration frequency
《中国医疗设备》 2025 (8)
1-6,6
广西壮族自治区食品药品监督管理局课题(桂药监科直属[2023]004号).
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