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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

  • 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.

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.