Based on IEC 601-1. Specifies safety requirements for oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a medical gas pipeline system. Replaces the first edition.
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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