Laboratory proficiency testing for creepage distance and electrical clearance test of medical electrical equipment based on GB 9706.1-2020
10.19745/j.1003-8868.2024194
- VernacularTitle:基于GB 9706.1-2020的医用电气设备爬电距离与电气间隙试验的实验室能力验证
- Author:
Xiao-Ming GAO
1
;
Song-Yan XU
;
Xiao-Peng HAN
;
Zhen-Shi LIANG
;
Man ZHANG
;
Ting-Ru GUAN
;
Hui-Ru WANG
;
Yuan-Yuan QU
;
Xin-Hua XIANG
Author Information
1. 中国食品药品检定研究院,北京 102629
- Keywords:
creepage distance;
electrical clearance;
medical electrical equipment;
proficiency testing;
GB 9706.1-2020
- From:
Chinese Medical Equipment Journal
2024;45(10):54-59
- CountryChina
- Language:Chinese
-
Abstract:
Objective To clarify the understanding of types of laboratories and manufacturers for GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance by laboratory proficiency testing for creepage distance and electrical clearance test.Methods An operation guide was formed according to the testing program in GB 9706.1-2020,and the homogeneity and stability of the samples were evaluated according to CNAS-GL003:2018 Guidance on Evaluating the Homogenneity and Stability of Samples Used for Proficiency Testing.Robust statistic methods were used to assess the quantitative parameters of the test results of the participating laboratories according to the requirements in GB/T 28043-2019 Statistical methods for use in proficiency testing by interlaboratory comparison;the results reported by the expert laboratories were used as the specified values of the qualitative parameters.SPSS 25.0 statistical software was used for data analysis.Results All the results of the crreepage distance and electrical clearance tests met the requirements for homogeneity and stability.Of the 46 laboratories involved in,37 ones did have comprehensive satisfactory determinations while the remained 9 ones not.Conclusion Some laboratories don't behave well in understanding the standard,which have to be reformed accordingly to enhance their proficiencies.[Chinese Medical Equipment Journal,2024,45(10):54-59]
