ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic gas scavenging systems. It is applicable in conjunction with IEC 60601-1:1988.
The requirements of ISO 11197:2004 take priority over those of IEC 60601-1:1988.
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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