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)

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.

Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung 2:2004)

Dieser Teil der ISO 10555 legt allgemeine Anforderungen für intravaskulären Katheter jedes Verwendungszwecks
fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
Sie gilt nicht für Zubehörteile zu intravaskulären Kathetern, die in einer gesonderten Norm erfasst werden.

Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales (ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)

La présente partie de l'ISO 10555 fixe les prescriptions générales relatives aux cathéters intravasculaires fournis dans des conditions stériles, non réutilisables, pour toute application. Elle n'est pas applicable aux accessoires de cathéters intravasculaires, qui feront l'objet d'une norme distincte.

Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:1995, vključno z Amd 1:1999 in Amd 2:2004)

General Information

• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 09-Jul-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 6 - Catheters and enteral feeding tubes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 10-Jul-2013
• Completion Date: 10-Jul-2013
• Directive: 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST 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)

Relations

• Replaces: EN ISO 10555-1:1996/A2:2004 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM 2:2004)
• Effective Date: 20-May-2009
• Replaces: EN ISO 10555-1:1996 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995)
• Effective Date: 20-May-2009
• Replaces: EN ISO 10555-1:1996/A1:1999 - Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1996/AM1:1999)
• Effective Date: 20-May-2009
• Replaced By: EN ISO 10555-1:2013 - Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
• Effective Date: 22-May-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-1:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 10555-1:2000
SIST EN ISO 10555-1:2000/A1:2000
SIST EN ISO 10555-1:2000/A2:2004
6WHULOQLåLOQLNDWHWUL]DHQNUDWQRXSRUDERGHO6SORãQH]DKWHYH,62
YNOMXþQR]$PGLQ$PG
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-
1:1995, including Amd 1:1999 and Amd 2:2004)
Sterile intravaskuläre Katheter zur einmaligen Verwendung -Teil 1: Allgemeine
Anforderungen (ISO 10555-1:1995, einschließlich Änderung 1:1999 und Änderung
2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie 1: Prescriptions générales
(ISO 10555-1:1995, y compris Amd 1:1999 et Amd 2:2004)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2009
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-1:2009

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SIST EN ISO 10555-1:2009
EUROPEAN STANDARD
EN ISO 10555-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.25 Supersedes EN ISO 10555-1:1996
English Version
Sterile, single-use intravascular catheters - Part 1: General
requirements (ISO 10555-1:1995, including Amd 1:1999 and
Amd 2:2004)
Cathéters intravasculaires stériles, non réutilisables - Partie Sterile intravaskuläre Katheter zur einmaligen Verwendung
1: Prescriptions générales (ISO 10555-1:1995, y compris -Teil 1: Allgemeine Anforderungen (ISO 10555-1:1995,
Amd 1:1999 et Amd 2:2004) einschließlich Änderung 1:1999 und Änderung 2:2004)
This European Standard was approved by CEN on 19 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10555-1:2009
EN ISO 10555-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 10555-1:2009
EN ISO 10555-1:2009 (E)
Foreword
The text of ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004 has been prepared by Technical
Committee ISO/TC 84 “Medical devices for injections” of the International Organization for Standardization
(ISO) and has been taken over as EN ISO 10555-1:2009 by Technical Committee CEN/TC 205 “Non-active
medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:1996.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national
...