Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
医用电气设备第2-56部分:体温测量用体温计的基本安全和基本性能的特殊要求
发布日期:
2017-03-16
ISO 80601-2-56:2017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。本文件规定了电动临床温度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。
临床温度计可以配备接口,以容纳二级指示器、打印设备和其他辅助设备,从而创建医用电气系统。本文件不适用于辅助设备。
测量体温的医用电气设备在本文件范围内。
ISO 80601-2-56:2017未规定用于在室内环境条件下对单个人群进行个体非侵入性人体发热温度筛查的温度计筛查要求,如IEC 80601?2?59[4]所述。
如果某一条款或子条款明确规定仅适用于医用电气设备,或仅适用于医用电气系统,则该条款或子条款的标题和内容应如此说明。如果情况并非如此,则本条款或子条款适用于医用电气设备和医用电气系统(视情况而定)。
除IEC 60601-1:2005+A1:2012、7.2.13和8.4.1外,本文件中的具体要求未涵盖本文件范围内医用电气设备或医用电气系统预期生理功能所固有的危险。
注:更多信息见IEC 60601?1:2005+A1:2012,4.2。
ISO 80601-2-56:2017 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 a body temperature is inside the scope of this document.
ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601?2?59[4].
If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.
Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601?1:2005+A1:2012, 7.2.13 and 8.4.1.
NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.