1、 The positioning and differences between the two standards
These two standards play different roles in the compliance testing of LED beauty masks and usually need to be used in combination:
GB/T 36419-2018 "Household and Similar Use Skin Beauty Devices": This is a product performance standard for the beauty device body, which was published in June 2018 and implemented on January 1, 2019. It is the framework basis for whether the product is qualified or not.
GB/T 20145-2006 "Photobiological Safety of Lamps and Lamp Systems": This is a safety standard for light radiation itself, equivalent to CIE S009/E: 2002 (i.e. IEC 62471), to evaluate the potential photobiological hazards of light sources to the eyes and skin.
Simply put, GB/T 36419 tube "Beauty device" and GB/T 20145 tube "Does light radiation harm people" are both indispensable.
2、 Certification nature description
Strictly speaking, both of these standards belong to recommended national standards. The so-called "GB/T 36419 certification" is not a mandatory certification in the sense of administrative licensing, but a third-party organization with CNAS/CMA qualifications is commissioned to issue testing reports according to the standards. However, due to the fact that domestic e-commerce platforms such as Tmall and JD.com, supermarkets, and corporate bidding generally require relevant quality inspection reports, it is almost equivalent to a "quasi mandatory" qualification at the commercial level.
3、 GB/T 36419-2018 Scope of Application and Core Content
Scope of application
Suitable for household and similar skin beauty appliances with a rated voltage not exceeding 250V, and can be used as reference for appliances in beauty salons, salons, and similar scenarios; Examples include laser or strong light source appliances, red light and vibration beauty appliances. Red light, blue light, near-infrared and other LED photon masks can generally reference this standard.
Core testing content
Mainly including electrical safety, noise, material safety, structural and design requirements (such as anti scalding, anti misoperation), signs and instructions, etc. It is more like a framework of "performance/material/logo description" and cannot replace safety compliance alone.
Functional expansion requirements
If the product has functions such as microcurrent, radio frequency, ultrasound, heating and cooling, vibration, etc. in addition to LED light, special testing items need to be added according to the corresponding output principle. In addition, if clinical efficacy such as treatment and repair is claimed, it may touch upon the regulatory path of medical devices and cannot be treated as ordinary beauty appliances.
4、 GB/T 20145-2006 Scope of Application and Testing Principles
Scope of application
Applicable to all incoherent broadband electric light sources (including LED, but not including laser), for evaluating the photobiohazards of light radiation in the wavelength range of 200nm to 3000nm. The LED beauty mask is closely attached to the face and has a long exposure time, so photo biological safety is of utmost importance in detection.
Eight types of hazards evaluated
Covering UV hazards to the skin and eyes, near UV hazards to the eyes, retinal blue light hazards (with a focus on blue light masks), retinal blue light hazards (from small light sources), retinal thermal hazards, retinal thermal hazards from weak visual stimuli, infrared radiation hazards to the eyes, and skin thermal hazards.
Blue light hazard limits and grouping
Blue light hazards are divided into four groups based on their radiance (LB): no hazard (RG0, LB ≤ 100 W · m ⁻² · sr ⁻¹), low hazard (RG1, ≤ 1 × 10 ⁴), medium hazard (RG2, ≤ 4 × 10 ⁶), and high hazard (RG3,>4 × 10 ⁶). In the promotion of home beauty masks, it is generally required to reach RG0 exemption level or RG1 low-risk level, and RG2 and above must be marked with a warning "Do not stare at light sources" and not suitable for home use.
5、 Supporting guidance document for blue light hazard assessment
In practical testing, GB/Z 39942-2021 "Application of GB/T 20145 to Evaluate the Blue Light Hazards of Light Sources and Luminaires" (equivalent to IEC TR 62778:2014) is often used. It provides a blue light hazard assessment method and risk group boundary condition determination process for visible light (380-780nm) products, which is the direct basis for many testing institutions to issue blue light rating reports. Testing is usually recommended at a distance of 200mm and a field of view of 11mrad.
6、 Sample and testing condition requirements
Sample status: It should be the final product, including the driving power supply and cooling system, to ensure data representativeness; Suggest preparing no less than 3 samples to ensure data reproducibility.
Testing environment: Photobiological safety testing must be conducted in a dark room with an ambient illumination of less than 1lx to avoid stray light interference; The testing distance is determined according to the type of lighting fixture.
Performance testing items typically include LED wavelength, irradiance (accuracy of wavelengths around 630-660nm for red light and 415nm for blue light), and other optoelectronic parameters.
7、 Complete compliance portfolio recommendations
LED beauty masks are sold in compliance in the domestic market, and it is recommended to follow the following combination instead of just making two GB/T reports:
Safety category (mandatory): GB 4706.1-2024 General Safety+GB 4706.15-2008 Special Requirements for Skin and Hair Care Devices; It is recommended to add GB 4706.85-2008 to the mask with infrared function.
Performance category (recommended): GB/T 36419-2018 serves as the framework for product performance and labeling.
Light safety category: GB/T 20145-2006 (combined with GB/Z 39942-2021) issues a report on the classification of photobiological safety and blue light hazards.
Export connection: If exported overseas at the same time, the IEC 62471 report can directly correspond to GB/T 20145, achieving "one test for both domestic and foreign use".
8、 Process and cycle of handling
The general process is as follows: confirm the testing plan and applicable standards → send more than 3 sets of complete machine samples → conduct safety testing in the laboratory according to the GB 4706 series, conduct photobiological safety testing according to GB/T 20145, and conduct performance testing according to GB/T 36419 → issue various standard testing reports → use by the enterprise for e-commerce entry, listing, filing, or promotion. The normal cycle is about 7-15 working days, and if rectification is involved (such as adjusting the LED beads or adding scattering structures if the blue light exceeds the standard), it will be correspondingly extended. The report should be given priority to third-party laboratories with CNAS and CMA logos to ensure the platform's approval rate.
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