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§ 213.65 Equipment construction.

21 CFR 213.65

Citation21 CFR 213.65
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 213.65 Equipment construction.

(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.