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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.

  1. Ensure conformance with applicable clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
  2. Implement appropriate testing program following good manufacturing practices
  3. Document all testing results and maintain records
  4. Apply proper certification labeling with required statements
  5. Submit product reports and supplemental reports as required using Form FDA 3632
  6. Ensure quality system addresses radiation safety and conformity to standards through design controls
  7. Pay special attention to safety interlock requirements for Class IIIb or IV lasers
  8. Review and comply with all applicable safety requirements
  9. Maintain proper documentation of compliance with both FDA and IEC requirements
  10. 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

  • 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
This post is licensed under CC BY 4.0 by the author.