1、 Detecting background
Beauty masks use LED red, blue, near-infrared and other light sources to act on the facial skin. As the product is used closely to the eyes, photobiological safety is a core compliance item. The purpose of testing is to quantify the potential harm of light sources to the eyes and skin, classify risk groups, and provide a basis for platform review, instruction manual warnings, and product design.
2、 Scope of application
LED beauty masks, phototherapy masks, red/blue/composite light masks, and products with neck or local irradiation accessories suitable for household or similar environments. Not applicable to laser beauty devices, intense pulsed light (IPL) equipment, and Class II/III medical equipment products claiming medical treatment purposes.
3、 Testing basis
Based on IEC/EN 62471 "Photobiological Safety of Lamps and Lamp Systems", refer to IEC 60601-2-83, IEC 60335 series, and relevant regulations in the sales location for product positioning. Exporting to the EU requires a combination of CE, RoHS/REACH; The US market is paying attention to the FDA's classification criteria for phototherapy products and Amazon's category requirements.
4、 Testing items
Spectral parameters: center wavelength, spectral distribution, half wave width, actual output of each mode.
Radiation level: Use the irradiance at the location and evaluate the apparent radiance if necessary.
Hazard assessment: Retinal blue light hazard, retinal heat hazard, near-infrared hazard, ultraviolet hazard, and skin photochemical and thermal hazard.
Usage conditions: single course of treatment, daily frequency, cumulative exposure, fitting distance, light leakage, and exposure around the eyes.
Function verification: timed shutdown, temperature rise, mode switching output consistency, single fault state.
Identification verification: Risk warnings, contraindications, usage duration, and protection requirements for the body and instructions.
5、 Testing process
Confirm product claims and light source specifications, determine worst case mode; Arrange test points according to actual usage posture; Measure the output and exposure of each frequency band; Perform hazard weighting calculation according to standards; Divide risk groups; Verify the consistency of the label instructions; Provide a testing report.
6、 Judgment and Grading
According to IEC 62471, products are classified into RG0, RG1, RG2 and other levels. RG0 has relaxed exemption restrictions, RG1 requires normal behavior constraints, and RG2 and above require restricted exposure and strengthened warnings. Due to its close proximity to the eyes, even if RG1 is measured, it is recommended to include instructions in the user manual to avoid direct vision, control the duration, and use with caution when using photosensitive masks.
7、 Frequently Asked Questions
Inconsistencies between the prototype sent for testing and mass production, claimed wavelength deviation from actual output, testing only single mode and missing composite light, ignoring eye leakage, and lack of contraindications in the manual will all result in distorted conclusions or rejection of the review.
8、 Preparation before commissioning
Prepare a complete prototype, light source specification sheet, various mode parameters, claimed efficacy copy, instruction manual and label draft, and expected usage duration; Provide efficacy statements supported by clinical or literature to facilitate the evaluation of the consistency between the promotional approach and the testing conclusions.
Contact phone number: 19925421523
