EN ISO 10555-4:2023
(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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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 notice
The text of ISO 10555-4:2023 has been approved by CEN as EN ISO 10555-4:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 10555-4
Third edition
2023-11
Intravascular catheters — Sterile and
single-use catheters —
Part 4:
Balloon dilatation catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 4: Cathéters de dilatation à ballonnets
Reference number
ISO 10555-4:2023(E)
ISO 10555-4:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10555-4:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Detectability of the balloon position . 2
4.3 Designation of nominal size . 2
4.4 Physical requirements . 2
4.4.1 Balloon rated burst pressure (RBP) . 2
4.4.2 Balloon fatigue; freedom from leakage and damage on inflation . 2
4.4.3 Balloon deflation time . 2
4.4.4 Balloon diameter to inflation pressure (balloon compliance) . 2
4.4.5 Crossing profile . 3
4.4.6 Balloon removal . 3
4.5 Information to be supplied with the catheter . 3
Annex A (normative) Test for rated burst pressure (RBP). 4
Annex B (normative) Balloon fatigue test for freedom from leakage and damage
on inflation . 6
Annex C (normative) Test for balloon deflation time . 8
Annex D (normative) Test for balloon diameter to inflation pressure (balloon compliance) .10
Annex E (normative) Determination of crossing profile .12
Annex F (normative) Test method for balloon removal .14
Annex G (informative) Rationale and guidance .16
Bibliography .17
iii
ISO 10555-4:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and catheters, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 10555-4:2013), which has been
technically revised.
The main changes are as follows:
— added a definition for balloon rated burst pressure (RBP) (see 3.2);
— added a definition (see 3.3), requirement (see 4.4.5), and created test method (see Annex E) for
crossing profile;
— added guidance on endpoint of deflation period (see Annex C);
— defined effective length of the balloon (see 3.4);
— expanded radio-detectability to include detectability by x-ray or by other means (see 4.2);
— within designation of nominal size, added the minimum inner diameter of the introducer, guide
catheter, sheath, etc. that can be used with the catheter (see 4.3);
— added requirement (see 4.4.6) and test method (see Annex F) for balloon removal without damage
after inflation and deflation;
— added annex for rationale of changes and guidance (see Annex G).
A list of all parts in the ISO 10555 series can be found on the ISO website.
iv
ISO 10555-4:2023(E)
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
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