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ILNAS-EN ISO 10651-6:2009 Edition 04/2009
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
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Abstract

ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988. The requirements of ISO 10651-6:2004 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.

Status

Standard - Superseded

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)    14/03/2009
end of the vote on the project      date of anouncement (doa)    31/07/2009
start of the vote on the final project    13/11/2008   date of publication (dop)    31/10/2009
end of the vote on the final project    13/02/2009   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
ILNAS-EN ISO 80601-2-79:2019
ILNAS-EN ISO 80601-2-80:2019

Relations to older standards
ILNAS-EN ISO 10651-6:2004

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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