Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. 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 UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; - lights connected to surgical instruments; - luminaires of an emergency lighting, which are covered by IEC 60598-2-22.
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