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ILNAS-EN ISO 10555-1:2009 Edition 05/2009
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
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Abstract

Specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. Does not apply to intravascular catheter accessories, which will be covered by a separate standard.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

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)    19/04/2009
end of the vote on the project      date of anouncement (doa)    31/08/2009
start of the vote on the final project    18/12/2008   date of publication (dop)    30/11/2009
end of the vote on the final project    18/03/2009   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 10555-1:2013

Relations to older standards
ILNAS-EN ISO 10555-1:1996/A2:2004
ILNAS-EN ISO 10555-1:1996/A1:1999
ILNAS-EN ISO 10555-1:1996

International Classification for Standards (ICS codes) :

11.040.25 : Syringes, needles and catheters

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