Laser beauty devices (for hair removal, skin rejuvenation, pigmentation removal, etc.) deliver energy directly to human skin and fall under high-energy laser radiation equipment. For global market access including CE, FDA and NMPA, test reports complying with the IEC 60601 series are required as a fundamental component of the technical documentation.
IEC 60601-1 defines the baseline general electrical safety requirements, while IEC 60601-2-22 specifies dedicated safety requirements for laser equipment. Both standards are mandatory and must be applied together.
01 Core Definition of the Two Standards
IEC 60601-1: General Safety Framework
It stipulates the basic safety and essential performance requirements for medical electrical equipment with a hazard-based clause structure, covering risks such as electric shock, mechanical hazards, radiation, overheating and fire.
Key principle: Where a particular standard exists, IEC 60601-1 shall not be used alone. It must be applied in conjunction with the relevant particular standard.
IEC 60601-2-22: Particular Requirements for Laser Equipment
Applicable to laser equipment for surgical, aesthetic, therapeutic and diagnostic applications, covering Class 3B, Class 4 and Class 1C laser products.
Laser beauty devices generally belong to Class 3B or Class 4 laser products and are therefore subject to this standard.
Current valid edition: 4th edition (2019 + Amendment 1:2026). Key updates include:
Relationship Between the Two Standards
IEC 60601-1 serves as the general base standard, while IEC 60601-2-22 is the dedicated particular standard. Test reports must demonstrate compliance with both general and particular requirements. Clauses not modified by the particular standard remain fully applicable from the general standard.
02 Core Test Requirements
Laser Product ClassificationClassification shall be performed in accordance with IEC 60825-1. Aesthetic laser devices are typically Class 3B or Class 4.
Protective Housing and InterlocksBeam enclosures shall be fitted with interlock devices that terminate laser emission immediately upon opening.
Authorisation ControlsClass 3B / Class 4 devices shall require a key or password for activation to prevent unauthorised use.
Emergency StopAn easily accessible emergency stop function must be implemented.
Output Parameter AccuracyWavelength, power, energy density, pulse duration and other parameters shall match the labelled nominal values.
Basic Electrical Safety ItemsLeakage current, protective earth resistance (≤0.1Ω), dielectric withstand test and other tests follow IEC 60601-1.
03 Application Process
Step 1: Pre-Consultation and Standard Confirmation
Select an accredited third-party testing laboratory with CNAS and CMA recognition. Submit product technical documentation to confirm the test scope, applicable standard versions (must be currently valid), cost and lead time.
Step 2: Document Preparation and Application Submission
Complete the test application form, submit full technical files and prepare representative product samples.
Step 3: Laboratory Testing and Evaluation
The laboratory conducts testing on samples per IEC 60601-1 and IEC 60601-2-22. Tests include but are not limited to:
Electrical safety tests (leakage current, dielectric withstand, protective earth resistance)
Laser radiation safety (output parameters, interlock effectiveness, warning labelling)
Mechanical safety
Environmental adaptability
Step 4: Non-Conformity Rectification and Retest
In case of non-conformities, the manufacturer shall implement technical corrections and provide evidence or revised samples until all test items pass.
Step 5: Report Compilation and Issuance
After successful testing, the laboratory compiles all measured data and issues the official test report. The report can be used for CE certification, FDA registration, NMPA registration and other compliance activities.
04 Required Document Checklist
Product Technical Files
Schematic diagrams and PCB layout drawings
Product operating principle diagrams and block diagrams
Product BOM (Bill of Materials)
Critical component list (cables, plugs, fuses, varistors, optocouplers, X/Y capacitors, transformers, etc.)
Datasheets for all critical components
Product Labelling and User Documentation
Product nameplate (including model, ratings and manufacturer information)
User manual (covering intended use, safety warnings and operating procedures)
Risk Management Documentation
Laser-Related Documentation
Samples
Representative mass-production samples (typically 1–2 units)
05 Key Compliance Reminders
Verify standard versionsConfirm the standard version adopted by the test laboratory is the current valid edition (IEC 60601-2-22:2019+AMD1:2026).
Joint assessment of both standardsIEC 60601-1 cannot be used standalone; joint evaluation with the particular standard is mandatory.
Risk management files are a critical audit focusPrepare complete risk management plans, reports and risk analysis documents in advance.
06 Our Services
As a professional third-party testing laboratory, we provide the following services for laser beauty device testing to IEC 60601-1 and IEC 60601-2-22:
Accreditations: CMA, CNAS, IAS laboratory accreditations
Full-scope testing: Complete test packages covering electrical safety, laser radiation safety, mechanical safety and environmental adaptability
End-to-end project support: Document pre-review, sample testing, non-conformity rectification support and report issuance, all in one service
Standards coverage: IEC 60601-1, IEC 60601-2-22 and IEC 60825-1
Extended services: Technical support for CE certification, FDA registration and NMPA registration
Custom service: If you are unsure which standards apply to your laser beauty device or what documents to prepare, send us your product specification sheet. Our engineers will create a tailored test plan for you.
