SIST EN ISO 10555-4:2024
(Main)Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
This document specifies requirements for balloon dilatation catheters supplied sterile and intended for
single use.
This document does not specify requirements for vascular stents (see ISO 25539-2).
NOTE Guidance on the selection of balloon materials is given in Annex G.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO 10555-4:2023)
Dieses Dokument legt Anforderungen an Ballondilatationskatheter fest, die steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
Dieses Dokument legt keine Anforderungen für Gefäßstents fest (siehe ISO 25539 2).
ANMERKUNG Ein Leitfaden hinsichtlich der Auswahl von Ballonwerkstoffen ist in Anhang G angegeben.
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters de dilatation à ballonnets (ISO 10555-4:2023)
Le présent document spécifie les exigences générales relatives aux cathéters de dilatation à ballonnets fournis stériles et non réutilisables.
Le présent document ne spécifie pas d’exigence relative aux endoprothèses vasculaires (voir l’ISO 25539-2).
NOTE Des recommandations relatives au choix des matériaux de ballonnets sont données à l’Annexe G.
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za širjenje žil (ISO 10555-4:2023)
Ta dokument določa zahteve za balonske katetre za širjenje žil, dobavljene v sterilnem stanju in namenjene za
enkratno uporabo.
Ta dokument ne določa posebnih zahtev za žilne opornice (glej standard ISO 25539-2).
OPOMBA: Smernica glede izbire materialov za balonske katetre je v dodatku G.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10555-4:2024
01-marec-2024
Nadomešča:
SIST EN ISO 10555-4:2013
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za
širjenje žil (ISO 10555-4:2023)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation
catheters (ISO 10555-4:2023)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4:
Ballondilatationskatheter (ISO 10555-4:2023)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters
de dilatation à ballonnets (ISO 10555-4:2023)
Ta slovenski standard je istoveten z: EN ISO 10555-4:2023
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-4:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10555-4:2024
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SIST EN ISO 10555-4:2024
EN ISO 10555-4
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 10555-4:2013
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 4: Balloon dilatation catheters (ISO 10555-4:2023)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 4: Cathéters de dilatation à einmaligen Verwendung - Teil 4:
ballonnets (ISO 10555-4:2023) Ballondilatationskatheter (ISO 10555-4:2023)
This European Standard was approved by CEN on 24 November 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-4:2023 E
worldwide for CEN national Members.
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SIST EN ISO 10555-4:2024
EN ISO 10555-4:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10555-4:2024
EN ISO 10555-4:2023 (E)
European foreword
This document (EN ISO 10555-4:2023) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and 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 May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-4:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement n
...
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