医疗电气设备.第2-58部分:眼科手术用晶状体移除装置和玻璃体切除装置基本安全性和重要性能的详细要求

[中文适用范围]： 本国际标准适用于眼科手术用晶状体摘除装置和玻璃体切除装置（如 201.3.208 和 201.3.217 中定义）以及可连接到本医疗电气设备@的相关配件（以下简称为）的基本安全和基本性能我的设备。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@，则该条款或子条款同时适用于 ME 设备和相关的 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。 [外文原描述]： IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. 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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.