2026-09-09
Medical devices in a medical gas installation — table of classes, gas produced in the hospital as a medicinal product
In brief. Medical devices in a medical gas installation are a dozen or more separate devices — from the gas supply sources to the hoses — each with its own standard, CE marking and class. The class is determined by the intended purpose declared by the manufacturer and by Annex VIII to Regulation (EU) 2017/745. Oxygen supply sources, pressure regulators and concentrators are typically in class IIb (rule 12), while tubes, fittings and hoses are in class IIa (rule 2). The complete installation is an assembly of these devices and does not itself receive CE marking — the reasoning is set out in the article: a medical gas installation as an assembly of devices. Gas produced in the hospital plant room is a medicinal product described by a Pharmacopoeia monograph, and responsib...
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