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ILNAS-EN ISO 8835-2:2009 Edition 04/2009
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
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Abstract

ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions. ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.

Status

Standard - Withdrawn

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
14/03/2012
Reference

Relations

Evolutions
ILNAS-EN ISO 80601-2-13:2012

Relations to older standards
ILNAS-EN ISO 8835-2:2007

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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