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Laser Products - Performance Standards and Safety Requirements

This guidance provides comprehensive requirements for manufacturers of laser products, covering design, manufacturing, testing, labeling, reporting, and safety requirements under the Federal Food, Drug and Cosmetic Act. It applies to all laser products manufactured after August 2, 1976, except for components sold to manufacturers, repair components, and export-only products.

  1. Establish classification of laser product based on accessible radiation levels
  2. Implement required safety features based on product classification
  3. Design and validate protective housing and safety interlocks
  4. Develop and implement quality control testing program
  5. Create required labeling and documentation
  6. Establish recordkeeping system for test results and communications
  7. Prepare and submit initial FDA product report
  8. Set up system for annual reporting
  9. Develop procedures for accident reporting and recall management
  10. Train personnel on safety requirements and procedures
  11. Consider need for variance applications if standard requirements cannot be met
  12. Implement specific requirements for medical or demonstration laser products if applicable

Key Considerations

Non-clinical testing

  • Must establish and maintain a testing program to ensure compliance
  • Life testing required to substantiate that product will not emit increased radiation levels with age
  • Testing records must be maintained for 5 years

Human Factors

  • Controls must be located to avoid operator exposure during manipulation
  • For Class IIIb and IV systems, emission indicators must provide sufficient warning time (2-20 seconds) before emission

Labelling

  • Certification and identification labels required
  • Warning logotype required for Class II, IIIa, IIIb, and IV products
  • Aperture warning labels required where laser radiation exceeds Class I
  • Labels must be permanently affixed and readable without exposure to radiation

Safety

  • Protective housing required for all laser products
  • Safety interlocks required for removable protective housings
  • Remote interlock connector required for Class IIIb and IV systems
  • Key control required for Class IIIb and IV systems
  • Beam attenuator required for Class II, IIIa, IIIb, and IV systems
  • Scanning safeguard required to prevent hazardous exposure

Other considerations

  • IEC 60825-1: Safety of laser products
  • IEC 60601-2-22: Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
  • ANSI Z136.1: Safe Use of Lasers

Original guidance

  • Laser Products - Performance Standards and Safety Requirements
  • HTML / PDF
  • Issue date: 1992-06-01
  • Last changed date: 2023-02-21
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Radiological Health
  • ReguVirta summary file ID: ac42ca042a86d98ae8d4058032ea5552
This post is licensed under CC BY 4.0 by the author.