Medical electrical equipment-Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
医用电气设备
发布日期:
2020-05-12
本文件适用于临床温度计及其附件(以下简称医用电气设备)的基本安全和基本性能。本文件规定了
医用电子体温计的一般要求和技术要求。本文件适用于所有
用于测量患者体温的电子体温计。
临床体温计可以配备接口,以适应二级指标、打印
设备和其他辅助设备来创建ME系统。本文件不适用于
辅助设备。
测量和显示体温的医用电气设备在本文件的范围内。包含以下内容:BS EN ISO 80601-2-56:2017
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This document specifies the
general and technical requirements for electrical CLINICAL THERMOMETERS. This document applies to all
electrical CLINICAL THERMOMETERS that are used for measuring the BODY TEMPERATURE of PATIENTS.
CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing
equipment, and other auxiliary equipment to create ME SYSTEMS. This document does not apply to
auxiliary equipment.
ME EQUIPMENT that measures and displays a BODY TEMPERATURE is inside the scope of this document.Incorporates the following:BS EN ISO 80601-2-56:2017