This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
Normative references
Clause 2 of the general standard applies except as follows:
Addition:
IEC 60417, Graphical symbols for use on equipment
IEC 60598-2-9, Luminaires – Part 2: Particular requirements. Section Nine: Photo and film luminaires (non-professional)
ISO 11664-1, Colorimetry – Part 1: CIE standard colorimetric observers
CIE 13.3, Method of Measuring and Specifying Colour Rendering Properties of Light Sources
CIE 15, Colorimetry
CIE 69, Methods of characterizing illuminance meters and luminance meters: Performance, characteristics and specifications
CENTRAL ILLUMINANCE
Ec
illuminance at a 1000 mm distance (or a measurement distance specified by the MANUFACTURER if the specified working range does not include 1 000 mm) from the light-emitting area of the ME EQUIPMENT in the LIGHT FIELD CENTRE without any obstruction of the light beam DEPTH OF ILLUMINATION ABOVE 60%
working distance around the 1 000 mm distance (or a measurement distance specified by the MANUFACTURER if the specified working range does not include 1 000 mm) below the emitting surface of the ME EQUIPMENT, in which the illuminance reaches at least 60 % of CENTRAL ILLUMINANCE (Ec)
LISUN following instruments fully meet IEC 60601-2-41 Medical electrical equipment -Part 2-41: Particular requirements for the basic safety and essential performanceof surgical luminaires and luminaires for diagnosis
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