§ 213.65. Equipment construction.
92 words·~1 min read·
/us/cfr/t21/s§ 213.65·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.