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现行 CSA C22.2 NO.80601-2-59:21
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Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening 医用电气设备.第2-59部分:人体体温筛查用筛查温度计的基本安全和基本性能的特殊要求
发布日期: 2021-07-01
CSA序言这是CSA C22的第二版。2第80601-2-59号,医用电气设备-第2-59部分:用于人体发热温度筛查的筛查温度计的基本安全和基本性能的特殊要求,采用了相同名称的IEC(国际电工委员会)标准80601-2-59(第二版,2017-09),但有加拿大的偏差。它取代了2010年以CAN/CSA-C22发布的上一版本。2第80601-2-59号(采用IEC 80601-2-59:2008)。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。本标准拟与CAN/CSA-C22结合使用。2号。 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。范围和目的通用标准2第1条适用,但以下情况除外:201.1.1*范围替换:IEC 80601的本部分适用于在受控环境条件下,用于人体非侵入性体温筛查的筛查温度计(以下简称ME设备)的基本安全性和基本性能。 本文件规定了筛选温度计的实验室特性测试限值。注101:筛查温度计用于筛查人类受试者,并检测高于正常值的皮肤温度。皮肤温度升高后,需要使用临床温度计进行后续温度测量(见ISO 80601-2-56[30])。注102此类设备的主要部件通常称为红外摄像机。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)。 201.1.2对象替换:本特定文件的目的是为筛选201.3.209中定义的温度计确定特定的基本安全和基本性能要求。
CSA PrefaceThis is the second edition of CSA C22.2 No. 80601-2-59, Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-59 (second edition, 2017-09). It supersedes the previous edition, published in 2010 as CAN/CSA-C22.2 No. 80601-2-59 (adopted IEC 80601-2-59:2008). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.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 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 objectClause 1 of the general standard2 applies, except as follows: 201.1.1 * Scope Replacement: This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH.NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]).NOTE 102 The main part of such equipment is commonly referred to as an infrared camera. 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. 201.1.2 Object Replacement: The object of this particular document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SCREENING THERMOGRAPHS as defined in 201.3.209.
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发布单位或类别: 加拿大-加拿大标准协会
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