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ILNAS-EN ISO 10651-4:2009 Edition 04/2009
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
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Abstract

ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators. Rationale statements are given for ISO 10651-4:2002.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 215 : Respiratory and anaesthetic equipment

Directives

93/42/EEC : Medical devices
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

Implementation

start of the vote on the project      date of ratification (dor)    21/03/2009
end of the vote on the project      date of anouncement (doa)    31/07/2009
start of the vote on the final project    20/11/2008   date of publication (dop)    31/10/2009
end of the vote on the final project    20/02/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions

Relations to older standards
ILNAS-EN ISO 10651-4:2002/AC:2006
ILNAS-EN ISO 10651-4:2002

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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