BS EN 60601-2-5:2015适用于车辆的基本安全和基本性能 201.3.216中定义的超声波理疗设备，以下简称 我的设备。本标准仅适用于采用单平面的超声波理疗设备 每个治疗头的非聚焦圆形换能器，产生垂直于治疗头的静态光束 治疗头的面部。本标准也适用于用于治疗癌症的超声波理疗设备 疾病、伤害或残疾的补偿或减轻。如果是组合设备（例如，额外配备功能或 此类设备还应符合任何特定要求 规定附加功能安全要求的标准。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 60601-1-2:2007EN 60601-1-2:2007EN 60601-1-2:2007/勘误表1:2010IEC 61689:2007EN 61689:2007IEC 62127-1:2007EN 62127-1:2007IEC 62127-2:2007EN 62127-2:2007IEC 60601-2-36:1997EN 60601-2-36:1997IEC 61161:2006EN 61161:200793/42/EECIEC 62462:2007ISO/IEC指南98:2007IEC 60050-802IEC 609-2001替换了目前所有可用的EN 60601-462:2001修订版购买时包含在本文件的购买中。

BS EN 60601-2-5:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.This standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD.This standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability.In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular standard specifying safety requirements for the additional function.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 60601-1-2:2007EN 60601-1-2:2007EN 60601-1-2:2007/Corrigendum 1:2010IEC 61689:2007EN 61689:2007IEC 62127-1:2007EN 62127-1:2007IEC 62127-2:2007EN 62127-2:2007IEC 60601-2-36:1997EN 60601-2-36:1997IEC 61161:2006EN 61161:200793/42/EECIEC 62462:2007ISO/IEC Guide 98:2007IEC 60050-802IEC 60469-1:1987Replaces BS EN 60601-2-5:2001 which remains currentAll current amendments available at time of purchase are included with the purchase of this document.