IEC 80601-2-58:2014适用于用于眼科手术的晶状体摘除装置和玻璃体切除装置以及可连接到该医用电气设备（以下简称医用电气设备）的相关附件的基本安全和基本性能。除通用标准第7.2.13条和第8.4.1条外，本标准的具体要求不包括本标准范围内医用电气设备或医用电气系统预期生理功能的固有危险。第二版包括修改，以考虑在批准第一版作为欧洲医疗器械指令期间提交的意见，以及在本标准第一版定稿期间来自其他国家委员会的意见。

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.