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现行 BS EN 60601-2-62:2015
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Medical electrical equipment-Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment 医用电气设备
发布日期: 2015-06-30
BS EN 60601-2-62:2015适用于高性能车辆的基本安全和基本性能 201.3.218中定义的强度治疗超声设备,以下简称 我的设备。本国际标准添加或替换IEC 60601-1中列出的以下条款: 专用于高强度治疗超声设备。如果某条款或子条款专门适用于医用电气设备,或 仅适用于ME系统,该条款或子条款的标题和内容将说明这一点。如果不是这样的话 在这种情况下,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)。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 在本标准的范围内,本标准的具体要求不包括 通用标准7.2.13和8.4.1中的规定除外。交叉引用:IEC 60601-1-2:2007 IEC 61689:2013IEC/TS 61949IEC 62127-1IEC 62127- 2IEC 62359IEC 6255IEC/TS 625564EN 60601-1-2:2007EN 60601-1-2:2007+corr。购买本文件时包括购买费用。
BS EN 60601-2-62:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as ME EQUIPMENT.This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT.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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.Cross References:IEC 60601-1-2:2007IEC 61689:2013IEC/TS 61949IEC 62127-1IEC 62127-2IEC 62359IEC 62555IEC/TS 625564EN 60601-1-2:2007EN 60601-1-2:2007+corr. March:2010EN 61689:2013CLC/TS 61949EN 62127-1EN 62127-2EN 62359EN 6255593/42/EECIEC 60601-2-5IEC 60601-2-36IEC 60050-802IEC 60529IEC 61161IEC 61828IEC 62649IEC 62464-1IEC 62555IEC/TR 62781ISO/IEC Guide 98-3:2008EN 60601-2-5EN 60601-2-36EN 60529EN 61161EN 61828EN 62464-1EN 62555All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
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