Determination ideas and influencing factors of essential performance for GB 9706 series of standards
10.19745/j.1003-8868.2024218
- VernacularTitle:GB 9706系列标准中基本性能的确定思路及影响因素分析
- Author:
Bo LIU
1
;
Ya-Nan LI
;
Long-Fei ZHANG
;
Fei-Xiang HOU
;
Yu-Chen MAO
;
Peng-Yue GAO
Author Information
1. 天津市医疗器械质量监督检验中心,天津 300384
- Keywords:
GB 9706 series of standards;
medical electrical equipment;
essential performance;
risk analysis;
electromagne-tic compatibility
- From:
Chinese Medical Equipment Journal
2024;45(11):72-76
- CountryChina
- Language:Chinese
-
Abstract:
The risks related to the essential performance were analyzed with considerations on the concept of the essential performance in GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance,and the determination process for the essential performance of medical electrical equipment was summarized.The essential performance of the example equipment was clarified with the semi-quantitative risk analysis,and the influences of the arrangement of the electromagnetic compatibility test on the determination of the essential performance were explored with the conducted immunity test and conventional test.References were provided for standard users to understand and determine the essential performance effectively.[Chinese Medical Equipment Journal,2024,45(11):72-76]
