---
kind: "section"
citation: "21 C.F.R. § 880.6600"
title: "21"
number: "880.6600"
heading: "Ultraviolet (UV) radiation chamber disinfection device."
url: "https://uscodex.org/cfr/21/880.6600"
---

# §880.6600. Ultraviolet (UV) radiation chamber disinfection device.

- (a) **Identification.** An ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of non-porous equipment surfaces by dose-controlled UV irradiation. This classification does not include self-contained open chamber UV radiation disinfection devices intended for whole room disinfection in a health care environment.
- (b) **Classification—** Class II (special controls). The special controls for this device are:
  - (1) Performance testing must demonstrate the following:
    - (i) **The chamber's ability to control the UV radiation dose during operation.**
    - (ii) **The chamber's disinfection performance through microbial challenge testing.**
    - (iii) **Evidence that the equipment intended to be processed is UV compatible.**
    - (iv) **Validation of the cleaning and disinfection procedures.**
    - (v) **The ability of the device to continue to perform to all specification after cleaning and disinfection.**
    - (vi) Whether the device generates ozone (if so, [21 CFR 801.415](/cfr/21/801.415.md), Maximum acceptable level of ozone, applies).
  - (2) Appropriate software verification, validation, and hazard analysis must be performed.
  - (3) Appropriate analysis and/or testing must validate electrical safety, mechanical safety, and electromagnetic compatibility of the device in its intended use environment.
  - (4) The labeling must include:
    - (i) **UV hazard warning labels.**
    - (ii) **Explanation of all displays and/or labeling on user interface.**
    - (iii) **Explanation of device safety interlocks.**
    - (iv) **Explanation of all disinfection cycle signals, cautions and warnings.**
    - (v) **Device operating procedures.**
    - (vi) Identification of the expected UV lamp operational life and instructions for procedures on replacement of the UV lamp when needed.
    - (vii) **Procedures to follow in case of UV lamp malfunction or failure.**
    - (viii) **Procedures for disposing of mercury-containing UV lamps, if applicable.**
    - (ix) Identification of specific equipment that is compatible with the UV radiation dose generated by the device and that can safely undergo UV radiation low-level disinfection in the chamber device.
    - (x) Description of the required preparation of equipment for disinfection in the UV radiation chamber device.
    - (xi) **Identification of the specific microbes used in successful performance testing of the device.**
    - (xii) **Validated instructions for cleaning and disinfection of the device.**

## Notes

### Amendments

[80 FR 72588, Nov. 20, 2015]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[80 FR 72588, Nov. 20, 2015]