本国际标准适用于透镜的基本安全和基本性能 眼科手术用移除装置和玻璃体切除装置（定义见201.3.208和201.3.217）以及可连接到此医用电气设备（以下简称医用电气设备）的相关附件。 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）。 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。交叉引用:EN ISO 11607-1:2009/A1:2014ISO 11607-1:2006/Amd 1: 2014ISO 11607-2:2006/Amd 1:2014EN 55011CISPR 11IEC 60601-1-2:2014EN 60601-1-2:2015EN ISO 11607-2:2006/A1:2014EN 61847IEC 60825-1EN 60950-1IEC 61847EN 60065EN 60825-1IEC 60950-1IEC 60065包含以下内容:修订，2019年9月

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.Cross References:EN ISO 11607-1:2009/A1:2014ISO 11607-1:2006/Amd 1:2014ISO 11607-2:2006/Amd 1:2014EN 55011CISPR 11IEC 60601-1-2:2014EN 60601-1-2:2015EN ISO 11607-2:2006/A1:2014EN 61847IEC 60825-1EN 60950-1IEC 61847EN 60065EN 60825-1IEC 60950-1IEC 60065Incorporates the following:Amendment, September 2019