High-Intensity Mercury Vapor Discharge Lamps: Scope of Performance Standard and Requirements for General Purpose Lighting vs. Specialized Applications
This guidance clarifies that the performance standard (21 CFR 1040.30) for High-Intensity Mercury Vapor Discharge Lamps (HID) applies only to lamps used for general purpose lighting (e.g., in gymnasia, auditoriums, and stores), not to specialized applications like projection televisions.
Recommended Actions
- Determine if your HID lamp is intended for general purpose lighting or specialized application
- 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
- 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
- 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
Related references and norms
- 21 CFR 1040.30: Performance Standard for High-Intensity Mercury Vapor Discharge Lamps
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 summary file ID: 0ff6e9adb39cf8c1f435a46d466a2a41
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