CSA序言这是CSA C22的第二版。2第80601-2-56号，医用电气设备-第2-56部分:体温测量用临床温度计的基本安全和基本性能的特殊要求，采用了同名ISO（国际标准化组织）标准80601-2-56（第二版，2017-03），包括ISO修订件1:2018，加拿大偏差。它取代了2012年以CAN/CSAC22发布的上一版本。2编号80601-2-56（采用ISO 80601-2-56:2009）。它是CSA集团根据《加拿大电气规范》第二部分发布的一系列标准之一。 为简洁起见，本标准通篇称为“CSA C22.2 No.80601-2-56”。本标准拟与CAN/CSA-C22结合使用。2 No.60601-1:14，医用电气设备-第1部分:基本安全和基本性能的一般要求（采用IEC 60601-1:2005，包括修改件1:2012，带有加拿大偏差）。本标准适用于本标准规定范围内的合格评定。本标准的制定符合加拿大标准委员会对加拿大国家标准的要求。 CSA集团已将其作为加拿大国家标准发布。范围和目标IEC 60601-1:2005+A1:2012第1条适用，但以下情况除外:201.1.1示波器更换: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。本文件未规定用于在室内环境条件下对单个人群进行非侵入性人体体温筛查的温度计筛查要求，如IEC 80601-2-59[4]所示。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中固有的危险。注:更多信息见IEC 60601-1:2005+A1:2012，4.2。201.1.2对象更换:本特定文件的目的是为201中定义的临床温度计制定特定的基本安全和基本性能要求。 3.206及其附件。注:包括附件是因为临床温度计和附件的组合需要安全有效。附件会对临床温度计的基本安全性和基本性能产生重大影响。

CSA PrefaceThis is the second edition of CSA C22.2 No. 80601-2-56, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-56 (second edition, 2017-03), including ISO Amendment 1:2018. It supersedes the previous edition, published in 2012 as CAN/CSAC22.2 No. 80601-2-56 (adopted ISO 80601-2-56:2009). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as "CSA C22.2 No. 80601-2-56" throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.Scope and object IEC 60601-1:2005+A1:2012, Clause 1 applies, except as follows: 201.1.1Scope Replacement: 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 a BODY TEMPERATURE is inside the scope of this document.This document 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. 201.1.2 Object Replacement: The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for a CLINICAL THERMOMETER, as defined in 201.3.206, and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the CLINICAL THERMOMETER and the ACCESSORIES needs to be safe and effective. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER.