The EN 62471 (equivalent to IEC 62471) photobiological safety certification for LED facial beauty devices is a core compliance requirement
for products entering the EU market.
1. Standard positioning and scope of application
EN 62471 is the photobiological safety standard for lamps and lamp systems adopted by the European Union, which is fully consistent with
IEC 62471. This standard covers a wavelength range from 200nm to 3000nm and is applicable to non-laser light source devices such as LED
facial beauty masks, assessing the potential hazards of their optical radiation to the skin and eyes.
II. Risk Level Classification
The standard categorizes photobiological safety risks into four levels, and LED facial mask beauty devices typically need to meet either the
exemption level (RG0) or the low-risk level (RG1) to comply with market regulations:
Exemption level (RG0): No photobiological hazard under normal conditions
Low risk level (RG1): No harm under normal behavior restrictions
Medium risk level (RG2): relies on human eye avoidance response (such as blinking), and prolonged gaze poses a risk
High-risk grade (RG3): Even short-term exposure may cause harm, and it is generally prohibited for use as a regular product
Due to the close contact of LED face masks with the face, the irradiance received by the human eyes and skin is much higher than that of
ordinary lighting. If it reaches the RG2 or RG3 level, it will not be able to pass market supervision in many EU countries.
III. Core testing items
Based on the characteristics of LED facial mask beauty devices, the focus of testing is primarily on the following dimensions:
Retinal blue light hazard
Blue light with a wavelength of 400nm–500nm can penetrate the lens and reach the retina, and long-term exposure may lead to macular
degeneration. The weighted radiance (LB) should be ≤100 W·m⁻²·sr⁻¹ (RG0 standard).
Ultraviolet radiation hazards
Detect leaks within the 200nm–400nm wavelength band to prevent skin erythema, photoaging, or electric ophthalmia. The ultraviolet irradiance
(EUV) limit for the skin and eyes is ≤0.0001 W/cm².
Infrared radiation hazards
For red or near-infrared functions (780nm–3000nm), the standard limit for assessing the risk of corneal burns or lens cataracts caused by thermal
effects is typically required to be ≤10 mW/cm².
Retinal thermal hazard
Evaluate the potential damage of thermal effects from light sources on the retina, ensuring safety in both continuous wave and pulsed wave modes.
IV. Testing Process
Preliminary consultation and data preparation
The enterprise needs to provide technical documents such as product manuals, circuit diagrams, LED bead specifications, control methods (pulse
frequency, duty cycle), and so on.
Sample submission and mode setting
Usually, 2-3 prototypes are required, and the laboratory will confirm the "worst operating condition" (such as all light sources turned on,
maximum brightness) as the testing state.
Optical measurement in a darkroom
Measurements were conducted in a darkroom using a dual monochromator spectroradiometer (covering 200nm–3000nm):
Irradiance test: Simulate skin exposure and use an integrating sphere probe to receive
Radiance test: To simulate the risk of direct eye exposure, the imaging system needs to limit the field of view angle
Data analysis and grade evaluation
Input the spectral data into a dedicated algorithm, perform weighted calculation based on standards (such as combining blue light hazards with B(λ)
function convolution), and ultimately determine the RG0/RG1/RG2/RG3 levels.
Report preparation and certification
After verification, a bilingual (Chinese and English) test report bearing the CNAS and CMA logos will be issued. This report can be used for market
access such as CE certification in the European Union.
V. Compliance significance and risk warning
The necessity of market access
EN 62471 is the core basis for photobiological safety in the EU CE certification and is also a standard recognized by major global regulatory agencies
such as the FDA and NMPA. Products that fail to pass the test are at risk of being removed from shelves, recalled, and subject to legal liability.
Typical non-conforming case
The market has seen instances where LED strip lights were found to have hazardous levels in RG2, causing retinal blue light hazards and thermal
hazards after being used for more than 0.25 seconds, leading to consumer complaints and brand crises.
