21 CFR 213.65
§ 213.65 Equipment construction.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 213.65, § 213.65 Equipment construction, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86042
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Full text
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or medical gases shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.
(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, containers, closures, in-process materials, or medical gases so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.