EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

Publication date:   Feb 28, 2010

General information

99.60 Withdrawal effective   Mar 9, 2016

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.01   Medical equipment in general

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11197:2004

NOW

WITHDRAWN
EN ISO 11197:2009
99.60 Withdrawal effective
Mar 9, 2016

REVISED BY

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EN ISO 11197:2016

Relations

Adopted from ISO 11197:2004 IDENTICAL