医疗电气设备.第2-29部分:放射疗法模拟器的基本安全和重要性能的特殊要求

[中文适用范围]： 替代：本国际标准适用于放射治疗模拟器（以下简称ME设备）的基本安全和基本性能。如果某条款或子条款专门旨在仅适用于 ME 设备或仅适用于 ME 系统，则该条款或子条款的标题和内容将如此说明。如果情况并非如此，则该条款或子条款适用于相关的 ME 设备和 ME 系统。除通用标准 7.2.13 和 8.4.1 之外，本标准中的具体要求不涵盖本标准范围内 ME 设备或 ME 系统的预期生理功能所固有的危险。注：另见通用标准4.2。补充： 本标准是指通用标准第 2 章和本标准第 2 章所列出的适用的并列标准。以下并列标准不适用： – IEC 60601-1-10。 [外文原描述]： IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.