In 1977, the International Electrotechnical Commission (IEC) formulated a series of standards to protect consumers from faulty and dangerous equipment. This involves carefully testing the safety and performance of consumer equipment in multiple categories. In the United States, the technology needs the FDA's permission before the equipment can even consider obtaining IEC certification.
SAIDI is the first manufacturer of red light physiotherapy panel lamps to pass the testing of home medical device products. The power cord is in line with two plugs (L, N) and is not grounded. If other home propaganda 3 plugs (L, N, GND) pass the test of home medical devices, it must be false publicity. We Passed six tests of medical device IEC60601 certification.
The specific relevant standards in IEC 60601 certification include the following considerations. IEC 60601 involves applying technical standards to consumer electrical equipment to evaluate their safety and performance.
IEC 60601-1 and IEC 60601-1-11: This standard is applicable to home light therapy equipment except laser equipment. It is to ensure that the equipment is safe for consumers. Home users do not receive the same training as medical professionals, so it is necessary to formulate stricter safety regulations.
IEC 60601-1-2: Medical electrical equipment must minimize or eliminate emissions of electromagnetic disturbances.
IEC 60601-2-57 and IEC 60601-2-83: These safety and effectiveness standards are applicable to non-laser household light therapy equipment, including LED light treatment equipment, and are designed to ensure the safety of non-professional operators.
IEC 62471: This standard is applicable to the lighting system in LED equipment. These lamps emit specific visible and invisible light wavelengths. The standard outlines exposure limits to protect users from accidental injury. IEC certification basically covers all relevant potential safety hazards and takes into account the ease of use and effectiveness. At the same time, IEC shows a high degree of technical proficiency and attention to details when evaluating other types of equipment used for advanced health care.
IEC also supervises other electronic medical equipment, including high-frequency surgical equipment, cardiac defibrillators, ultrasound equipment, nerve and muscle stimulators, ventilators, anesthesia systems, dialysis equipment, incubators, laser equipment, infusion pumps, electrocardiogram equipment, pacemakers, hearing aids, radiotherapy equipment, magnetic resonance imaging (MRI) equipment, blood pressure monitoring equipment, phototherapy equipment, etc. As mentioned earlier, equipment is not eligible for IEC certification until it passes some FDA regulations for the first time. In the next section, we mention that the FDA participates in the licensing of medical devices for consumers, because this is another important step that equipment must go through before considering obtaining IEC 60601 certification.
The U.S. market requires manufacturers to show the FDA the basic level of safety and effectiveness through the agency's license. Reputable manufacturers follow these guidelines by determining the intended use of the equipment. This includes specifying the wavelength and direction of use. To a large extent, the evaluation process involves not only independent testing, but also relying on reputable clinical research to reach reliable conclusions. It is about the security of the device. Other considerations about whether the device contains adware and hardware. Long-term clinical studies on the benefits of red light therapy for patients show that red light therapy can successfully improve many biomarkers related to overall health. In addition, it is also recommended due to the lack of side effects or adverse events. It should also be noted that although R+, NIR+ and blue light wavelengths are approved by the FDA, other colors in the spectrum have not yet been approved. The above spectrum is still the most effective wavelength for treatment.