Regulations last checked for updates: Jan 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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.

source: 89 FR 51770, June 18, 2024, unless otherwise noted.
cite as: 21 CFR 213.65