1、 What is IEC 62471
IEC 62471 "Photobiological Safety of Lamps and Lamp Systems" is an international core standard for evaluating the potential hazards of light source radiation to the human body (eyes and skin), and its technical content is consistent with CIE S 009. It is suitable for all electrically driven incoherent broadband light sources (including LEDs, excluding lasers), with an evaluation wavelength coverage of 200 nm to 3000 nm, covering ultraviolet, visible, and infrared bands. The red light pillow integrates a large number of red/near-infrared LED beads inside, which belongs to a typical "light system". Therefore, it is usually necessary to undergo IEC 62471 evaluation before being launched for sale.
2、 Why does the red light pillow require this evaluation
The red light pillow is mainly composed of 630-850 nm red light and near-infrared light. Although it does not contain high-risk blue light, there are still two types of risks that cannot be ignored: one is the thermal hazard to the retina (weighted assessment of 380-1400 nm), which may heat the retina when viewed directly with a high-intensity red light array for a long time; The second is the hazard of near-infrared radiation (780-3000 nm), which may cause thermal damage to the eye lens and skin. In addition, it is necessary to eliminate UV leakage or blue light impurities mixed in the light source. The standard requires measuring spectral distribution, irradiance, and radiance, and classifying them based on the exposure limits of each hazard.
3、 Hazard level (RG grouping)
IEC 62471 classifies products into four levels based on the maximum allowable exposure time:
RG0 (Exemption Level): No photobiohazard under foreseeable conditions of use, typically with unrestricted exposure;
RG1 (low-risk level): Normal people naturally avoid glare/heat discomfort, and generally do not cause harm;
RG2 (medium risk): Exposure is limited by avoidance reactions, and a warning label must be added;
RG3 (high risk level): Short term exposure is harmful and is usually not accepted.
Household red light pillows should generally reach RG0 or RG1, RG2 and above are usually not accepted on mainstream e-commerce platforms and cross-border sales.
4、 Testing conditions and procedures
The standard stipulates that the light source operates at maximum power, usually measuring radiance at a distance of 200 mm and a field of view of 1.7 mrad. It has been fully applied to LED products since September 2009. Firstly, use a spectral radiometer to measure the spectral distribution and confirm that the wavelength is consistent with the claimed "red light" band; Measure the effective irradiance/radiance at different angles and distances; Finally, the final level is automatically calculated by comparing the exposure limits of each hazard type, and the highest level among all hazards is used as the overall rating result of the machine.
5、 Certification and Compliance Requirements
In the European Union, IEC 62471 has been converted into EN 62471, which is a coordinated standard for CE certification of lamps and products containing light sources. The export of red light pillows to the European Union must complete this evaluation. In the United States, if claiming therapeutic effects, red light products often follow the 510 (k) process for FDA Class II medical devices, and the IEC 62471 report is one of the core documents for technical safety review; The common defects in FDA review include "photobiological safety and eye protection design". In China, the corresponding standard is GB/T 20145, and medical phototherapy equipment must also comply with YY 9706.257-2021 (corresponding to IEC 60601-2-57). Household medical device products generally require exemption or low-risk levels.
6、 Requirements for Labels and Instructions for Use
Reaching exemption level (RG0) usually does not require special warnings; Low risk level (RG1) should indicate radiation hazard information; Warning labels must be affixed and shielding measures recommended for medium risk level (RG2); High risk level (RG3) requires warning to avoid eye and skin exposure. The common practice is to cooperate with the instructions of "Do not look directly at the light source", recommend wearing goggles (especially when using near-infrared high-power panels), and indicate the recommended working distance and upper limit of single exposure time.
Contact phone number: 19925421523
