München – The expansion of hospital infrastructure, medical trends and technical innovations such as LEDs and AI increasingly require holistic testing approaches for medical lighting. TÜV SÜD Product Service explains the requirements of the Medical Devices Ordinance (MDR) for manufacturers, as well as those related to product safety and occupational safety.
“Dynamic technological progress means that medical lighting technology is opening up ever broader fields of application – from disinfection, phototherapy and endoscopy to infant heat radiators or laser devices for surgery,” says Florian Hockel, Segment Manager for Lights, Luminaires and Multimedia Products at TÜV SÜD . Expert estimates assume that the market will almost double in size from its current level of around eight billion US dollars by 2033. As an integral part of healthcare facilities, medical lighting not only plays a central role in the safety and comfort of patients and medical staff. It also enables precise diagnoses and thus further improved care. Increasing leaps in innovation and modern lighting trends are aimed at making the work of medical staff easier and at the same time reducing energy consumption. An example of this is the switch to LED lighting. It also offers longer durability and a more comfortable color temperature that resembles natural daylight and can be more precisely tailored to specific medical tasks. Last but not least, the high degree of color rendering allows more precise diagnoses and more targeted treatment.
From radiant heaters to surgical lasers – overview of a wide range of standards
At the end of a conformity assessment procedure according to MDR is the CE marking (see MDR, Article 20). For example, the effective light output or the radiation characteristics (glare) must be checked. Luminous flux or color temperature and light stability (flickering) are also relevant. Where the lighting design for medical products is purchased separately, problems sometimes arise if the parameters are not matched to the later application. In some cases, this means restarting the entire product development and a delayed market entry – with unplanned but avoidable follow-up costs.
The EN 60601 series regulates the basic safety and performance requirements for medical electrical equipment – including medical lighting. In the case of infant warmers, for example, one section of the standard relates to the explicit testing of infrared radiation. The maximum irradiance at any point on the underlay must not exceed 60 mW/cm2 – in the near infrared range it is 10 mW/cm2. During the test, the experts set the distance between the radiator and the mattress according to the associated specifications and detect the intensity with grids, IR detectors such as pyranometers and spectrometers.
In addition to medical safety, the product safety of lamps and lights and the lighting concept in the room are crucial. EN 12464-1 includes guidelines for the lighting of indoor workplaces – including in healthcare facilities. This is about visual performance, visual comfort and psychological well-being. “Not only the illuminance, the degree of reflection or the glare are checked. In Germany, DIN 5035-3 “Lighting with artificial light – Part 3: Lighting in healthcare” is also relevant. How even the light is, how the color is rendered and how a room is supplied with daylight also play a role,” says Florian Hockel. This minimizes accidents at work, reduces the likelihood of occupational diseases and even has an impact on staff productivity. In addition to the technical aspects, the focus is on economic efficiency.
The TÜV SÜD inspectors are represented worldwide and know the country-specific guidelines and standards, which can make test planning in the laboratory more efficient and thus speed up market access. In state-of-the-art test laboratories, automated measuring systems ensure even better data quality and shorter test times.
Additional Information:
https://www.tuvsud.com/de-mdr
www.tuvsud.com/licht-und-lampen
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