摘要
目的现有的GB/T 19146-2010《红外人体表面温度快速筛检仪》和GB/T 19665-2005《电子红外成像人体表面测温仪通用规范》2个相关国家标准在性能要求上差异明显,但适用范围和定义上区分度不高,导致部分红外热像仪生产企业采标不当,直接影响了该类产品的临床使用效果,本文为促进企业正确采标,对2个标准进行相关分析。方法本文从红外热像仪的基本原理出发,对比了GB/T 19146-2010和GB/T 19665-2005这2个标准间存在的异同。结果结果表明,2个标准基于不同的临床用途,其撰写思路和侧重点不同,主要表现在实验室误差和测温一致性方面的不同要求。结论通过对不同产品的性能测试结果进行分析,对标准的适用范围进行了明确区分,给相关生产企业提供合理的采标建议,也为监管部门提供必要的参考。
Objective The existing two relevant national standards,GB/T 19146-2010 Infrared Devices for Instant Screening of Human Skin Temperature and GB/T 19665-2005 General Specification for Electronic Infrared Imaging Thermometer of Body Skin,have obvious diferences in performance requirements,but the diference in scope and definition is not very distinct,which leads to improper adoption of standards by some manufacturers of infrared thermal imager.This directly afects the performance of this kind of products in clinical application.This paper analyzed the correlation between the two standards to promote enterprises to correctly adopt standards.Methods Based on the basic principle of infrared thermal imager,this paper compared the similarities and diferences between GB/T 19146-2010 and GB/T 19665-2005.Results The results showed that with diferent clinical applications,two standards had diferent writing ideas,mainly in the laboratory error and consistency of temperature measurement.Conclusion Based on the analysis of the performance test results of diferent products,the scope of application of the standard is clearly distinguished,and reasonable suggestions for the relevant manufacturers are provided,as well as necessary references for the regulatory authorities.
作者
钱学波
戴云旗
张赟
杨国涓
刘博
李立宾
陈成
QIAN Xuebo;DAI Yunqi;ZHANG Yun;YANG Guojuan;LIU Bo;LI Libin;CHEN Cheng(Department of Active Medical Device Tianjin Medical Devices Quality Supervision and Testing Center,Tianjin 300384,China;Department of Technology,Tianjin Medical Devices Quality Supervision and Testing Center,Tianjin 300384,China)
出处
《中国医疗设备》
2023年第1期20-24,共5页
China Medical Devices
基金
国家重点研发计划(2019YFD1712000)。
关键词
热辐射原理
红外热像仪
人体表面温度
适用范围
异同
thermal radiation theory
infrared thermal imager
human skin temperature
scope
similarities and diferences
