EN ISO 10555-4:2013

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)

ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO 10555-4:2013)

Dieser Teil der ISO 10555 legt Anforderungen an Ballondilatationskatheter fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
ANMERKUNG   Zu beachten sind ISO 11070, die Anforderungen an Zubehörteile zum Gebrauch mit intravaskulären Kathetern festlegt, ISO 25539 2, die Anforderungen an Einführsysteme festlegt, sofern sie einen integralen Bestandteil bei der Entfaltung des Gefäßstents darstellen und ISO 14630.

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters de dilatation à ballonnets (ISO 10555-4:2013)

L'ISO 10555-4:2013 spécifie les exigences générales relatives aux cathéters de dilatation à ballonnets fournis dans des conditions stériles, non réutilisables.

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za širjenje žil (ISO 10555-4:2013)

Ta del standarda ISO 10555 določa zahteve za balonske katetre za širjenje žil, dobavljene v sterilnem stanju in namenjene za enkratno uporabo.

General Information

• Status: Withdrawn
• Publication Date: 09-Jul-2013
• Withdrawal Date: 28-Nov-2023
• 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 - Non-active medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10555-4:2013 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)

Relations

• Replaces: EN ISO 10555-4:1997 - Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:1996)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 10555-4:1997/AC:2002 - Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:1996/Cor.1:2002)
• Effective Date: 17-Jul-2013
• Replaced By: EN ISO 10555-4:2023 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
• Effective Date: 07-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-4:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 10555-4:2000
SIST EN ISO 10555-4:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za
širjenje žil (ISO 10555-4:2013)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation
catheters (ISO 10555-4:2013)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4:
Ballondilatationskatheter (ISO 10555-4:2013)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters
de dilatation à ballonnets (ISO 10555-4:2013)
Ta slovenski standard je istoveten z: EN ISO 10555-4:2013
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-4:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-4:2013

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SIST EN ISO 10555-4:2013


EUROPEAN STANDARD
EN ISO 10555-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-4:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
4: Balloon dilatation catheters (ISO 10555-4:2013)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 4: Cathéters de dilatation à ballonnets Verwendung - Teil 4: Ballondilatationskatheter (ISO 10555-
(ISO 10555-4:2013) 4:2013)
This European Standard was approved by CEN on 29 May 2013.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-4:2013: E
worldwide for CEN national Members.

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SIST EN ISO 10555-4:2013
EN ISO 10555-4:2013 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 10555-4:2013
EN ISO 10555-4:2013 (E)
Foreword
This document (EN ISO 10555-4:2013) has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” in collaboration with 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 January 2014, and conflicting national standards shall be withdrawn at
the latest by January 2014.
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 10555-4:1997.
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 EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne
...