EN 794-1:1997+A2:2009

Lung ventilators - Part 1: Particular requirements for critical care ventilators EN 794-1:1997+A2:2009

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Apr 15, 2011

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

The scope given in clause 1 of the EN 60601-1:1989 applies except that 1.1 is replaced by the following.
1.1 This Part of this European Standard specifies requirements for lung ventilators intended for medical use. Additional Parts, e.g. concerning emergency and transport ventilators, home care ventilators, and recent developments such as jet and very high frequency ventilation and oscillation are under consideration. Requirements for ventilators intended for anaesthetic applications are given in prEN 740.

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

NOW

WITHDRAWN
EN 794-1:1997+A2:2009
99.60 Withdrawal effective
Apr 15, 2011

REVISED BY

WITHDRAWN
EN ISO 80601-2-12:2011