IEC 60601-2-41:2021适用于手术灯具和诊断灯具（以下简称ME设备）的基本安全和基本性能。 如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。 本特定标准不适用于 -前灯； -IEC 60601-2-18涵盖的内窥镜、腹腔镜及其光源； -ISO 9680涵盖的牙科用灯具； -IEC 60598-2-1和IEC 60598-2-4涵盖的通用灯具； -专用于治疗目的的灯具； -具有不同使用条件的特殊用途灯，例如仅用于净化空气和表面的光源、用于皮肤病诊断的紫外线灯、用于眼科的裂隙灯ogy，用于手术显微镜的灯和用于手术导航系统的灯； -连接到外科器械的灯，诸如发光牵开器； -IEC 60598-2-22涵盖的应急照明灯具。 手术灯具和诊断灯具是医疗器械，不是一般照明设备。 IEC 60601-2-41:2021取消并取代2009年发布的第二版和修正案1:20 13。本版构成技术修订版。 与上一版相比，此版本包括以下重大技术变更: a)修订了基本业绩说明； b)增加了与光生物危害相关的暴露限值、试验条件、计算方法和安全警示； c)删除术语“次要手术灯具”和“主要手术灯具”；d)增加了最大照度距离和参考距离的定义，并允许制造商在他们指定的参考距离处测量一些性能特征； e)将(x，y)颜色空间中的可接受色度区域替换为对Du，v的要求； f)增加了灯头在连接到悬挂系统时可接受的漂移的要求； g)增加了流体进入保护的要求； h)修订IEC 60601-2-41:2009和IEC 60601-2-41:2009/AMD1:2013的表201.101，并将其移至附录BB； i)指定了一种用于测量模拟腔中阴影稀释的新设备； j)装有距离传感器的灯具的规定试验条件。

IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, 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.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment.
IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) revised the statement of essential performance;
b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards;
c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”;
d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify;
e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v;
f) added a requirement for acceptable drift of the lighthead when attached to the suspension system;
g) added a requirement for fluid ingress protection;
h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB;
i) specified a new device for measuring SHADOW DILUTION in a simulated cavity;
j) specified test conditions for luminaires equipped with distance sensors.