医用电气设备电气间隙和爬电距离能力验证分析

Verification Analysis on the Electrical Clearance and Creepage Distance Ability of Medical Electrical Equipment

能力验证(ProficiencyTesting)是利用实验室间比对来判定实验室和检查机构能力的活动,是检验实验室检测水平的一项重要手段。通过能力验证项目的实施,还可以加强实验室间的技术交流,提高检测的质量和水平。电气间隙和爬电距离是医用电气产品重要的安全检测项目,由于产品结构复杂多样,掌握电气间隙和爬电距离的含义并正确应用对应的标准条款,是进行准确可靠检测的关键所在。本文对笔者参与中国食品药品检定研究院组织的《2015年全国医疗器械电气间隙和爬电距离能力验证试验》结果进行分析和讨论。

Proficiency testing is an activity to determine the ability of laboratories and inspection bodies by laboratorycomparisons, andan important means of verifying the laboratory examination level. Through the implementation ofproficiency testing project, the technical exchanges between the laboratories can be enhanced, and the quality andlevel of examination can also be improved. Electrical clearance and creepage distance are important safety testingprojects of medical electrical products, due to the complex structure of the products, in-depth understanding on themeaning of electrical clearance and creepage distance and correct application of the corresponding standard terms,are the key to accurate and reliable detection. This author participated in 2015 national medical equipment electricalclearance and creepage distance proficiency testing organized by Chinese Food and Drug Inspection Institute, andthe results are analyzed and discussed in this paper.