IEC 60601-2-41 Surgical Luminaires and Luminaires for Diagnosis Testing
Medical electrical equipment – Part 2-41: the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
IEC 60601-2-41 Scope:
IEC 60601 2 41 and EN 60601 2 41 testing applies to the basic safety and essential performance of surgical luminaires and luminaires for diagnosis, hereafter referred to as medical electronic equipment.
IEC 60601-2-41 testing 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 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.
Keystone Compliance assists manufacturers with IEC 60601-2-41 and EN 60601-2-41 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-41 test lab needs.