Analysis of electric shock protection requirements for IVD diagnostic equipment in IEC 61010-1:2010
10.7687/j.issn1003-8868.2017.11.079
- VernacularTitle:IEC 61010-1:2010体外诊断设备电击防护要求分析
- Author:
zhong Wen ZHANG
1
;
guang Ji LIU
;
jun Lian LIN
;
wen Xiu SHAO
;
jin Zhen DENG
;
liang Dong QIU
Author Information
1. 广东省医疗器械质量监督检验所
- Keywords:
IEC 61010-1:2010;
IVD diagnostic equipment;
electric shock protection;
protective earthing;
sampling needle
- From:
Chinese Medical Equipment Journal
2017;38(11):79-82
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the electric shock protection requirements of in vitro diagnostic equipment and to help manufacturers understand the relevant requirements in order to design products reasonably. Methods The requirements of IEC 61010-1:2010 were analyzed, the electric shock protection measures were explored, and the principles for protecting ground impedance against electric shock were described. An example was taken to study the electric shock protection measures for the sampling needle of the automatic bio-chemical analyzer, so that the existence of electric shock hazard could be determined. Results The sampling needle proved its rationality in structure design by avoiding the risk for being electriferous in case of failed basic insulation, although the requirements for protective earthing, double insulation or reinforced insulation were not met efficiently. Conclusion The requirements for electric shock protection can be determined based on comprehensive understanding of the standard, determination of electriferous components of the equipment as well as analysis on electric shock protection measures.
