High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications

What You Need to Know? 👇

What is the scope of FDA’s performance standard for high-intensity mercury vapor discharge lamps?

The FDA performance standard (21 CFR 1040.30) applies only to HID lamps used for general purpose lighting in areas where people congregate, such as gymnasia, auditoriums, and stores, not to all lamps that provide illumination.

Why did FDA establish the performance standard for mercury vapor discharge lamps?

FDA issued the standard in 1980 after numerous incidents where broken lamp envelopes in school gymnasia caused ultraviolet radiation injuries to spectators, resulting in emergency room treatments for photokeratitis and erythema.

Are HID lamps used in projection televisions subject to FDA’s performance standard?

No, HID lamps installed inside projection televisions are outside the scope of the performance standard because they’re protected from external impact and used for specialized applications, not general purpose lighting.

What health risks are associated with broken mercury vapor discharge lamps?

Exposure to ultraviolet radiation from broken lamp envelopes can cause painful injuries including photokeratitis (snow-blindness) and erythema (sunburn), particularly affecting people who remain exposed for extended periods.

How does the performance standard address safety concerns for mercury vapor lamps?

The standard establishes criteria for self-extinguishing (T Type) lamps and requires warning packaging for non-self extinguishing (R Type) lamps, advising against use where people congregate for extended periods.

What should importers do if their HID lamps are detained at customs?

Importers of HID lamps for specialized applications (not general purpose lighting) can refer to this FDA guidance document to clarify that their products are outside the scope of the performance standard requirements.

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What You Need to Do 👇

Recommended Actions

1. Determine if your HID lamp is intended for general purpose lighting or specialized application
2. For general purpose lighting HID lamps:
   • Ensure compliance with self-extinguishing requirements for T Type lamps
   • Include appropriate warnings on R Type lamp packaging
   • Submit FD Form 2877 for import clearance
3. For specialized application HID lamps:
   • Document intended use clearly in product documentation
   • Reference this guidance when responding to import officers
   • No FD Form 2877 required for import
4. Maintain documentation of intended use and application to support regulatory classification

Key Considerations

Labelling

• Non-self extinguishing (R Type) lamps must have packaging warnings indicating they should not be used in locations where people congregate for more than a few minutes

Safety

• Lamps must meet performance criteria for self-extinguishing (T Type) lamps when used for general purpose lighting
• The glass outer envelope must block transmission of short wavelength ultraviolet radiation from the discharge tube

Other considerations

• The standard applies only to HID lamps manufactured or assembled after March 7, 1980
• Specialized applications (e.g., projection TV lamps) installed inside equipment and not subject to external impact are outside the scope

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Related references and norms 📂

• 21 CFR 1040.30: Performance Standard for High-Intensity Mercury Vapor Discharge Lamps

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Original guidance

• High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications
• HTML / PDF
• Issue date: 2005-11-05
• Last changed date: 2020-03-24
• Status: FINAL
• Official FDA topics: Medical Devices, Radiation-Emitting Products
• ReguVirta ID: 0ff6e9adb39cf8c1f435a46d466a2a41