SR EN IEC 60601-2-41:2022

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

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; – li

98.45

Status : Valid
Approval date : 2/28/2022
Number of pages : 129
ICS : 11.040.20 Tranfusion, infusion and injection equipment,11.040.55 Diagnostic equipment,11.040.99 Other medical equipment
Technical Committee : 22 - Electrical equipment in medical practice

Relations with other standards: