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Quality Control Practices for Mercury Vapor Lamp Manufacturing and Testing

This guidance provides recommendations for quality control practices to ensure compliance with the Federal Performance Standard for Mercury Vapor Lamps. It covers quality assurance programs, pre-production evaluation, production testing, reliability testing, and quality audits for manufacturers of high-intensity mercury vapor discharge lamps.

  1. Establish comprehensive quality assurance program with written procedures
  2. Implement pre-production evaluation process:
    • Design review
    • Component evaluation
    • Prototype testing
  3. Set up production testing program:
    • Component and in-process testing
    • Final product testing with proper sampling
    • Documentation of results
  4. Establish reliability testing program to verify continued compliance
  5. Implement quality audit procedures:
    • Procedures audits
    • Product audits
    • Personnel evaluations
  6. Ensure proper labeling and warnings on products and packaging
  7. Maintain calibration of test equipment
  8. Keep complete records for 5 years
  9. Train personnel on proper test procedures and safety precautions
  10. Review and update procedures based on audit findings

Key Considerations

Non-clinical testing

  • Perform pre-production evaluation including design review, component evaluation, and prototype testing
  • Conduct production quality control testing including component, in-process, and final product testing
  • Implement reliability and life testing to verify continued compliance during useful life
  • Follow specified test conditions for lamp breakage and operation
  • Use valid sampling plans for testing based on MIL-STD-105D or MIL-STD-414

Labelling

  • Include manufacturer name, date of manufacture, and “T” or “R” designation on lamp
  • Apply required warning labels on lamp packaging
  • Ensure labels are permanent, legible and accessible
  • Include certification statement on packaging
  • Include warning statements in advertisements for non-self-extinguishing lamps

Safety

  • Verify self-extinguishing mechanism functions within 15 minutes after envelope breakage
  • Consider adverse effects of tolerances and environmental factors on safety mechanisms
  • Follow proper test procedures to avoid hazards from UV radiation, electrical shock, mercury vapor, etc.

Other considerations

  • MIL-STD-105D: Sampling Procedures and Tables for Inspection by Attributes
  • MIL-STD-414: Sampling Procedures and Tables for Inspection by Variables
  • ANSI C82.5-1977: American National Standards Specifications for High-Intensity Discharge Lamp Reference Ballasts

Original guidance

  • Quality Control Practices for Mercury Vapor Lamp Manufacturing and Testing
  • HTML / PDF
  • Issue date: 1980-05-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 9096e4ee29a11ff8277a566cc4a559cc
This post is licensed under CC BY 4.0 by the author.