Clause 1 of the general standard applies with the following replacements:
201.1.1 * Scope
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
– 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.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment.