Standard Overview
IEC 60825-1 is a core safety standard for laser products developed by the International Electrotechnical Commission, applicable to all laser equipment
emitting wavelengths in the range of 180 nm to 1 mm. This standard reduces the potential harm of laser radiation to the human body, especially the
eyes and skin, through laser level classification, protective measures, and labeling requirements. Laser hair caps, as consumer/medical devices containing
laser diodes, are usually required to undergo this certification for export to international markets.
Classification of laser safety levels
IEC 60825-1 classifies laser products into 7 safety levels (Class 1, 1M, 2, 2M, 3R, 3B, 4), and the common classifications of laser hair caps are as follows:
Class 1: Completely harmless under reasonable and foreseeable normal use conditions, even if exposed for a long time, it is safe. Most low-energy
laser hair caps can be classified as such if designed properly.
Class 3R: Medium power, direct gaze at the beam may cause eye damage. Some high-power hair caps may fall into this category.
The criteria for level determination include parameters such as laser wavelength, output power, pulse characteristics, etc., and are compared with the
achievable emission limit (AEL) of the corresponding level.
Core testing items
The IEC 60825-1 testing of laser hair caps mainly revolves around the following parameters:
Optical performance testing
Laser wavelength measurement
Output power/irradiance measurement
Energy density detection
Evaluation of Laser Beam Diameter and Radiation Direction
Laser grade identification
Determine the laser safety level (Class 1 or 3R, etc.) of the product based on test data
Complete radiation safety assessment
Identification and instruction manual review
Does the product label meet the standard requirements
Is the warning label and level label complete
Does the user manual contain sufficient safety warnings and operational guidance
Requirements for protective measures
If the laser hair cap is classified as Class 1M or above, the standard provides clear requirements for the engineering protection of the product:
Protective casing: Ensure that laser radiation leakage does not exceed safety limits
Safety interlock device: prevent accidental exposure
Beam control: Ensure that the laser is evenly irradiated and does not accidentally hit the eyes directly
Emergency stop mechanism: High level products require configuration
Class 1 products have relatively relaxed requirements for protective measures due to their inherent non hazardous nature, but still need to meet
basic labeling and instruction requirements.
Labeling and Identification Standards
Products certified by IEC 60825-1 must be labeled with the following information on the body and packaging:
Laser safety level (such as "Class 1 Laser Product")
Emission wavelength (such as 650 nm)
Maximum output power
Internationally recognized laser warning symbol (required for Class 1M and above)
Manufacturer information and certification mark
The instruction manual should include multilingual safety warnings, correct usage methods, potential hazard warnings, and emergency response measures.
Certification process
Prepare application materials: product manual, technical parameters, circuit diagram, laser specification sheet, etc
Select testing institution: Entrust a third-party laboratory with IEC 60825-1 testing qualifications and CNAS accreditation
Submit application and pay: send samples and sign testing contract
Laboratory testing: Conduct comprehensive testing on laser power, wavelength, grade classification, and other aspects
Result evaluation: The testing agency determines whether it meets the standard requirements based on the data
Issue report/certificate: After passing the test, issue IEC 60825-1 compliance testing report or certification certificate
The testing cycle is usually 2-4 weeks, and the cost varies depending on the laser level and product complexity.
Association with other certifications
EU CE certification: IEC 60825-1 is the technical basis for laser safety modules in CE certification, corresponding to the EN 60825-1 standard
US FDA registration: FDA Notice No. 56 allows the use of IEC 60825-1:2014 to replace some of the requirements of 21 CFR 1040.10, and the two can
be used in conjunction
Chinese National Standard: The corresponding domestic standard is GB 7247.1, and the technical content is equivalent to IEC 60825-1
Precautions
If the product also claims medical use, in addition to IEC 60825-1, it must also comply with IEC 60601-2-22 (Special requirements for medical laser
equipment) or IEC 60335-2-113 (Safety requirements for household beauty appliances)
Completing laser level testing alone does not mean completing all IEC 60825-1 certifications. Compliance with labeling, protective measures, and
instructions will also be reviewed
It is recommended to intervene in laser safety assessment during the product design phase to avoid cost increases caused by structural modifications
in the later stage
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