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EN ISO 10555-1:2009

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

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Jul 10, 2013

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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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

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Life cycle

PREVIOUSLY

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EN ISO 10555-1:1996

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EN ISO 10555-1:1996/A1:1999

WITHDRAWN
EN ISO 10555-1:1996/A2:2004

NOW

WITHDRAWN
EN ISO 10555-1:2009
99.60 Withdrawal effective
Jul 10, 2013

REVISED BY

WITHDRAWN
EN ISO 10555-1:2013

Relations

Adopted from ISO 10555-1:1995 IDENTICAL

Adopted from ISO 10555-1:1995/Amd 1:1999 IDENTICAL

Adopted from ISO 10555-1:1995/Amd 2:2004 IDENTICAL