21 CFR 880.6992
§ 880.6992 Medical washer-disinfector.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.6992, § 880.6992 Medical washer-disinfector, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90620
- Permanent ID
ys:prov:90620@1- SHA-256
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Full text
(a) Identification. A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.”
(1) Medical washer-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
(2) Medical washer-disinfectors that are intended to clean, low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.