Innovation Meets Regulation
In the ever-evolving landscape of medical technology, ensuring the safety and performance of surgical equipment is paramount. The IEC* 60601-2-41:2021 (Edition 3) standard sets forth the particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis. This globally recognized standard ensures that surgical lighting systems meet stringent criteria for illumination quality, thermal safety, and mechanical reliability.
At the forefront of innovation, our Getinge surgical lights are meticulously engineered to meet and exceed the requirements of IEC 60601-2-41 Ed.3. From optimal light intensity and color rendering to precise shadow management and thermal control, Getinge surgical lights are designed to support surgical teams with clarity, comfort, and confidence.
By aligning with this latest edition of the standard, we reaffirm our commitment to patient safety, clinical excellence, and regulatory compliance—delivering lighting solutions that empower surgical precision in every procedure.
The following outlines our alignment with IEC 60601-2-41 Ed.3, with a particular focus on safety aspects:
- Our surgical lights never exceed 160,000 Lux illumination along the vertical axis to ensure patient safety.
- The IEC standard recommends informing the surgical staff about the risks associated with overlapping light fields when irradiance exceeds 700 W/m². All our products include a visual indicator to inform users when high irradiance levels may occur due to overlapping light fields.
Get to know more on Maquet Ezea surgical light Careview feature - All our products undergo rigorous end-of-line testing during the design phase and throughout production to ensure full compliance with IEC 60601-2-41 Ed.3 before leaving the factory. The values indicated in the user manual represent average production values and not best-case measurements.
*IEC: International Electrotechnical Commission