Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
This guidance outlines FDA's approach regarding manufacturers' compliance with FDA's performance standards for laser products, specifically addressing the conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1. It applies to all laser products, including those that are both medical devices and electronic products.
Recommended Actions
- Ensure conformance with applicable clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
- Implement appropriate testing program following good manufacturing practices
- Document all testing results and maintain records
- Apply proper certification labeling with required statements
- Submit product reports and supplemental reports as required using Form FDA 3632
- Ensure quality system addresses radiation safety and conformity to standards through design controls
- Pay special attention to safety interlock requirements for Class IIIb or IV lasers
- Review and comply with all applicable safety requirements
- Maintain proper documentation of compliance with both FDA and IEC requirements
- Consider including additional useful information from non-comparable IEC clauses in FDA submissions where appropriate
Key Considerations
Non-clinical testing
- Testing must be performed in accordance with the standard on individual articles or through a testing program following good manufacturing practices
- Testing results must be documented and maintained in company records
- Classification testing may be requested by FDA to confirm proper laser product classification
Labelling
- Certification label must be permanently affixed or inscribed on the product
- Label must be legible and readily accessible when product is fully assembled
- Label must be in English language
- Specific certification statements are required depending on whether the product is a medical device or not
Safety
- Safety interlocks must have redundancy or safe-failure for Class IIIb or IV laser radiation protection
- Protective housing requirements must be met
- Remote interlock connector requirements must be met
- Key control requirements must be met
- Beam attenuator requirements must be met
- Scanning safeguard requirements must be met
Other considerations
- Products must comply with classification requirements
- Accessible emission limits must be respected
- Location of controls requirements must be met
- Viewing optics requirements must be met
- User information requirements must be met
Relevant Guidances
- Alternative Warning Statements for Laser Product User Information
- Beam Attenuator and Emission Indicator Requirements for Class II and IIIa Visible Laser Systems
- Laser Products - Performance Standards and Safety Requirements
- Laser Light Shows and Displays: Requirements for Aircraft Safety and Visual Control
- Use of Visible Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
- Alternative Identification Labeling Requirements for Class I Laser Products Integrated into Other Products
- Significant Risk Determination for Investigational Medical Laser Devices
- Classification of Electron Beam Accelerators Used as Laser Energy Sources
- Safety Requirements for Medical Laser Delivery Systems and Interlock Mechanisms
- Remote Interlock Connector Requirements for Laser Products
- User Instructions for Medical Laser Products: Safety Information and Radiation Hazard Protection Requirements
- Reproduction of Hazard Warning Labels in User Instructions for Laser Products with Cosmetic Enclosures
- Viewing Optics Performance Requirements for Surveying Laser Products
- Warning Label Requirements for Multiple Wavelength and Dye Laser Products
Related references and norms
- IEC 60825-1 Ed. 3: Safety of laser products - Part 1: Equipment classification and requirements
- IEC 60601-2-22 Ed. 3.1: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Original guidance
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- HTML / PDF
- Issue date: 2023-02-21
- Last changed date: 2023-02-21
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Laser Notice, Export, Medical Devices, Radiological Health, Radiology, Import
- ReguVirta summary file ID: bd61e943b00025cddea0904f155181da
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