本文件适用于眼科手术用晶状体摘除装置和玻璃体切除装置（定义见201.3.209和201.3.217）的基本安全和基本性能，以及可连接到该医疗电气设备（以下简称ME设备）的相关附件。如果某一条款或子条款专门适用于医用电气设备或医用电气系统，则该条款或子条的标题和内容应如此说明。如果不是这样，则该条或子条款适用于医用电子设备和医用电气系统。本文件范围内的医用电气设备或医用电气系统的预期生理功能所固有的危险不包括在本文件的具体要求中，第7条除外。 IEC 60601-1:2005的2.13和IEC 60601 1:2005/AMD2:2020以及IEC 60601-11:2005的8.4.1。IEC 80601-2-58:024取消并取代了2014年发布的第二版及其2016年修正案1:2016。本版本为技术修订版。与前一版本相比，本版本包括以下重大技术更改: a） 根据IEC 60601-1:2005、IEC 60601-1-2005/AMD1:2012和IEC 60601-11:2005/AMD2:2020的修订，调整本特定标准； b） 更新辅助资料，特别是IEC 60601-1:2005、IEC 60601-1-2005/AMD1:2012和IEC 60601-11:2005/AMD2:2020参考资料，以与IEC 60601-1: 2020和其他抵押品标准； c） 更新的规范性参考文献； d） 201.9.5.101增加了对应用零件中颗粒物的新要求； e） 增加了201.12.1.101.7中的阴影光方法； f） 澄清202.7.1.2中EMC要求的测试条件； g） 更新了表D.4参考资料，包括IEC对符号的具体参考资料，并删除了“附件AA，201.7.6.101”； h） 包括一个新的附件，以解决欧洲法规（EU）2017/745（附件BB）的相关一般安全和性能要求； i） 删除液化碎片透镜移除方法的所有引用。

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.