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ILNAS-EN 1282-2:2005+A1:2009 Edition 08/2009
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
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  • 28.5 / copy
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Abstract

This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given. This document is not applicable to specialized tracheostomy tubes.

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Standard - Superseded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)    16/07/2009
end of the vote on the project      date of anouncement (doa)    30/11/2009
start of the vote on the final project      date of publication (dop)    28/02/2010
end of the vote on the final project      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 5366:2016

Relations to older standards
EN 1282-2:2005/prA1
ILNAS-EN 1282-2:2005

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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