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SSH EN ISO 8835-5:2009

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

Oct 9, 2009
95.99 Withdrawal of Standard   May 13, 2015

General information

95.99     May 13, 2015

DPS

DPS/KT 215

European Norm

11.040.10  

English  

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Scope

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.
ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.
The requirements of ISO 8835-5:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

Related directives

Directives related to this standards.

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WITHDRAWN
SSH EN 740:2000

NOW

WITHDRAWN
SSH EN ISO 8835-5:2009
95.99 Withdrawal of Standard
May 13, 2015

REVISED BY

WITHDRAWN
SSH EN ISO 80601-2-13:2012

Related project

Adopted from EN ISO 8835-5:2009