DSF/prEN 60601-2-41
Medical electrical equipment -- Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
| Organization: | DS |
| Status: | inactive |
| Page Count: | 46 |
| ICS Code (Surgical instruments and materials): | 11.040.30 |
| ICS Code (Diagnostic equipment): | 11.040.55 |
scope:
Subclause 1.1 of the general standard is replaced by:
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 U.V. 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.
NOTE See also 4.2 of the General Standard.
This particular standard can also be applied to surgical luminaires and luminaires for diagnosis
used for compensation or alleviation of disease, injury or disability.
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