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现行 BS EN IEC 80601-2-77:2021
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Medical electrical equipment-Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment 医用电气设备
发布日期: 2021-10-14
IEC 80601的本部分适用于机器人辅助手术设备(RASE)和机器人辅助手术系统(RAS)的基本安全和基本性能,以下简称ME设备和ME系统及其交互条件和接口条件。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)。购买本文件时可获得的所有当前修订均包含在购买本文件中。
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. 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.All 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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