1、 Standard positioning and regulatory background
EN 62471 (equivalent to IEC 62471) is the core coordinated standard of the European Union for the photo biological safety of lamps and lamp
systems, which is included in the conformity assessment framework of the Low Voltage Directive (LVD) and the Artificial Light Radiation Directive
(AORD 2006/25). Since September 2010, LED products no longer use the laser standard IEC 60825 and must undergo a unified risk assessment
according to EN 62471. This is a mandatory prerequisite for LED lamps to enter the EU market and complete the CE marking.
2、 Scope of application and spectral coverage
This standard applies to all non laser light sources, including LED lights, LED modules, fluorescent lamps, and lighting systems. The evaluation of the
spectral range covers the entire spectrum from 200 nm to 3000 nm, including ultraviolet (UV), visible light (VIS), and infrared (IR) regions, with the
aim of systematically identifying potential acute and chronic damage to the skin and eyes from light radiation.
3、 Eight major photobiohazard testing projects
The laboratory needs to use a dual monochromatic spectrometer system in a dark room environment to measure the irradiance and radiance of LED
products for the following hazardous items:
Skin and Eye UV Hazards (180-400 nm): Evaluate corneal burns and skin erythema caused by UV radiation.
Near ultraviolet harm to the eyes (315-400 nm): detect cumulative lens damage and cataract risk.
Retinal blue light hazard (400-500 nm): The core project evaluates the photochemical damage to the retina caused by high-energy blue light and is a
mandatory test for all civilian LEDs.
Small light source retinal blue light hazard: a specialized assessment for small-sized LED light sources such as LED beads and indicator lights.
Retinal thermal hazard (400-1400 nm): Risk of burns to the retina and choroid caused by strong light heat.
Weak visual stimulation retinal thermal hazard: supplementary testing for low visibility infrared LEDs.
Eye infrared radiation hazard (780-3000 nm): Risk of lens cataracts induced by long-term infrared exposure.
Skin thermal hazard (380-3000 nm): Skin burns caused by high-intensity light exposure.
4、 Testing conditions and measurement methods
Test distance: General lighting fixtures are evaluated by default at an illuminance of 500 lx, with a minimum distance of not less than 200 mm;
according to the IEC/TR 62778 supplementary specification, for the convenience of horizontal comparison, the test distance is uniformly set at
200 mm.
Measuring field of view angle: uniformly set to 0.011 radians. If the actual angle of the light source is ≥ 0.011 radians, use the large light source
method to calculate the maximum safe illumination time; If it is less than this value, the small light source method is used.
Spectral acquisition: Obtain complete spectral data through a high-precision spectral radiation analyzer, combine testing distance and field of
view, calculate the effective radiation level of each hazard item, and compare it with the standard limit value.
5、 Classification and Meaning of Risk Levels
According to the test results, the product is classified into four risk levels, with higher levels having stricter safety requirements:
RG0 (Exemption/No Danger): No harm under any normal use conditions. Children's lighting fixtures, reading and writing desk lamps, and indoor
lighting in places where personnel stay for a long time must meet this level; The General Code for Building Environment in China also has mandatory
requirements for this.
RG1 (low risk/low hazard): Normal short-term exposure is risk-free, and the human blink reflex is sufficient for self-protection. Suitable for ordinary
household and commercial indoor lighting.
RG2 (medium risk/moderate risk): Direct gaze may cause glare or thermal discomfort, and the body's natural avoidance response can prevent injury.
Commonly used for outdoor high-power floodlights, street lamps, and stage lighting, warning information should be labeled on the outer packaging.
RG3 (high risk/high hazard): Even short-term exposure can cause irreversible eye or skin damage. Only for use in industrial professional scenarios,
civilian products are prohibited from being launched.
6、 Preparation of samples and technical documents
Before applying for certification, it is necessary to prepare:
Test samples: 2-3 sets of complete and normal working samples are provided for finished lighting products; If it is a lamp bead or patch type, 10-20
samples need to be provided. The sample must maintain consistency in structure and optical parameters with the mass-produced product.
Technical data: product manual, material BOM list, circuit schematic, PCB layout diagram; Finished products with optical lenses or soft light structures
also require optical design specifications.
Application documents: Fill in the standardized application form of the testing institution, listing the product model, specifications, application scenarios,
and manufacturer information.
7、 Certification process and cycle
Pre review: The testing agency conducts a pre review of the samples and data to confirm the product type and testing scope, usually within 1-2
working days.
Laboratory testing: Conduct spectral scanning, irradiance and radiance measurements, and weighted calculations in a CNAS/CMA qualified laboratory.
Data analysis and grading: Compare measurement data with standard limits to determine risk levels.
Report issuance: After passing the test, a formal EN 62471 testing report will be issued, clearly indicating the results of each project and the final risk level.
The testing cycle for standard LED lighting fixtures is usually 5-7 working days; Complex products, such as UV systems, may take 10-15 working days.
8、 Common reasons for non conformities and directions for rectification
Reading and writing desk lamp/children's lamp: high color temperature, blue peak wavelength of chip, lack of anti glare structure, leading to excessive
harm of blue light. Rectification suggestion: Choose low color temperature chips and add diffusion plates or filters.
UV sterilization LED: Insufficient sealing structure leads to UV leakage. Rectification suggestion: Optimize the packaging structure and add UV filters.
Bath heater/heating LED: High power and lack of insulation protection, resulting in excessive heat hazards to the skin and eyes. Rectification suggestion:
Add heat dissipation structure or power limitation.
Outdoor floodlights: High power products are prone to excessive blue and infrared thermal hazards. Rectification suggestion: Optimize optical design,
control beam angle and intensity distribution.
9、 Label and User Information Requirements
For products with RG2 and above levels, the standard requires mandatory:
Clearly label the risk level (such as RG2) on the product and outer packaging.
Additional warning signs, such as "Avoid direct eye contact with light sources" or "Avoid prolonged exposure".
Provide instructions on safe usage distance, maximum recommended exposure time, and necessary engineering control measures in the user manual.
10、 Relationship with other certifications
EN 62471 belongs to product testing certification, which is only responsible for the sample products and does not require factory review. The report is
valid for a long time as the product design has not changed and the standards have not been updated. However, it should be noted that:
LED self ballasted lights usually also need to comply with EN 62560;
LED modules must comply with EN 62031;
Electromagnetic radiation safety must comply with EN 62493;
Starting from February 2025, the certification of photobiological safety in the IECEE CB system has been transformed into the ACP (Aspect Certification
Program) mode, specifically for evaluating such horizontal standards.
