In 1977, the International Electrotechnical Commission (IEC) developed a series of standards to protect consumers from faulty and dangerous devices.
This involves careful testing for the safety and performance of consumer devices in a number of categories. In the US, before a device can even be considered for IEC certification, its tech first requires FDA clearance.
In the following sections, we discuss IEC 60601 and why among other things this sets the BIOMAX Series apart from other RLT manufacturers.
PlatinumLED is one of only two companies to have received this IEC 60601 certification, meaning that it has undergone and passed far more rigorous testing standards for safety and efficacy than almost all other red light therapy panels on the market.
Read on to learn more about IEC 60601 as well as its implications for PlatinumLED panel users.
IEC 60601 and PlatinumLED
The BIOMAX Series light therapy panels are now IEC 60601 certified.
The specific relevant standards within the IEC 60601 certification include the following considerations. IEC 60601 involves the application of technical standards to consumer electrical devices, evaluating them for safety and performance.
IEC 60601-1 and IEC 60601-1-11: This standard applies to at-home light therapy devices except laser devices. It is in place to ensure that devices are safe for use by consumers. Home users do not receive the same training as medical professionals, which makes stricter safety regulations a necessity.
IEC 60601-1-2: Medical electrical equipment must minimize or eliminate the emission of electromagnetic disturbances. BIOMAX red light therapy panels emit 0.0 µT at 4” from the device: in other words, there are no EMF emissions from BIOMAX devices.
IEC 60601-2-57 and IEC 60601-2-83: These safety and effectiveness standards apply to non-laser home light therapy devices including LED light therapy devices, intended to ensure the safety of lay operators.
IEC 62471: This standard applies to the lamp systems within LED devices. These lamps emit specific wavelengths of visible and invisible light. This standard outlines exposure limits to protect the user from unintentional harm.
IEC certification essentially covers all the relevant potential safety hazards, with considerations for ease of use and efficacy as well.
Meanwhile, the IEC displays a high degree of technical adeptness and attention to detail in its evaluation of other types of devices intended for advanced medical care.
The IEC also regulates other electronic medical equipment including high frequency surgical equipment, cardiac defibrillators, ultrasound devices, nerve and muscle stimulators, ventilators, anesthetic systems, dialysis equipment, incubators, laser equipment, infusion pumps, electrocardiographic equipment, pacemakers, hearing instruments, radiotherapy equipment, magnetic resonance imaging (MRI) equipment, blood pressure monitoring equipment, phototherapy equipment, and others.
As noted, devices do not qualify to be considered for IEC certification until they first pass a number of FDA regulations. In the next section, we mention the involvement of the FDA in the clearance of medical devices for consumer use, as this is another significant step that devices are required to go through before they can be considered for IEC 60601 certification.
PlatinumLED FDA Regulatory Clearance
The FDA began drafting regulations for red light therapy devices in 2023.
The US market requires that a manufacturer must demonstrate basic levels of safety and effectiveness to the FDA through that agency’s clearance.
Reputable manufacturers follow these guidelines by identifying the intended use for the device. This includes specifying the wavelengths used, and directions for use.
In large part, the evaluation process involves not only independent testing, but a reliance on reputable clinical research in order to come to dependable conclusions about the safety of a device. Additional considerations as to whether the device contains the software and hardware advertised.
A long background of clinical research into the benefits of red light therapy for patients has yielded results showing that red light therapy can successfully improve numerous biomarkers related to holistic health. It comes furthermore recommended due to its lack of side effects or adverse events.
It should also be noted that while R+, NIR+, and blue light wavelengths have FDA clearance, the other colors in the light spectrum remain unapproved. The above spectrums of light remain the most effective wavelengths for treatment.
Devices that emit other types of light, including blue, purple, yellow, green, cyan etc. remain less credible as treatment avenues, especially for key cell stimulation.
Better Treatment with the BIOMAX Series
BIOMAX Series devices feature the broadest spectrum of therapeutic wavelengths on the market, including the following:
- R+ wavelengths at 630nm and 660nm
- NIR+ wavelengths at 810nm, 830nm, 850nm, and 1064nm
- Trace amounts of 480nm blue light
Red light therapy is well known as an anti-aging treatment for the skin and the treatment of acne and chronic skin disorders, but its fundamental therapeutic value comes from stimulating the mitochondria.
Users enjoy numerous other benefits as a result of daily red light therapy use. Given the IEC 60601 certification, they have even more reason to be sure that the treatment is safe and effective.
Check out the BIOMAX Series for more information about the panels and to choose the one that is right for you.