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
INTERNATIONAL STANDARD ISO 10555-4:2023(E)
Intravascular catheters — Sterile and single-use
catheters —
Part 4:
Balloon dilatation catheters
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10555-1:2023, Intravascular catheters — Sterile and single-use catheters — Part 1: General
requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10555-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
balloon dilatation catheter
intravascular catheter fitted with a balloon, which is introduced into an artery or vein to dilate a part
or parts of the vascular system
3.2
balloon rated burst pressure
RBP
pressure at which the balloon bursts or leaks with an appropriate safety margin
3.3
crossing profile
maximum outer diameter found between the proximal end of the uninflated balloon and the distal tip
of the catheter
3.4
effective length of the balloon
length of the balloon intended to treat the lesion
ISO 10555-4:2023(E)
4 Requirements
4.1 General
Unless otherwise specified in this document, balloon dilatation catheters shall conform with the
requirements in ISO 10555-1.
4.2 Detectability of the balloon position
The balloon position shall be detectable by X-ray or by other means (ultra-sound, MRI, etc.).
Detectability shall be demonstrated by an appropriate test method, e.g. the test method specified in
ASTM F640-20 or DIN 13273-7.
4.3 Designation of nominal size
The nominal size of the catheter shall be designated by the following:
a) diameter(s) expressed in millimetres (rounded to the nearest 0,1 mm or 0,01 mm) of the inflated
balloon(s) or, for multidiameter balloon(s), the diameter of each portion at nominal pressure;
b) effective length of the balloon at nominal pressure(s);
c) diameter of the largest guidewire that can be used with the catheter, if applicable;
d) minimum inner diameter of the introducer, guide catheter, sheath, etc. that can be used with the
catheter.
NOTE For stent delivery systems, refer to ISO 25539-2.
4.4 Physical requirements
4.4.1 Balloon rated burst pressure (RBP)
Determine the RBP when tested in accordance with Annex A.
Longitudinal burst is the desirable balloon burst mode, though other modes are acceptable with
appropriate justification.
4.4.2 Balloon fatigue; freedom from leakage and damage on inflation
Evaluate the ability of the balloon to withstand 10 repeated inflation cycles to the RBP. When tested as
described in Annex B, there shall be no leakage or evidence of damage, such as herniation or bursting
of the catheter. In cases where 10 repeated inflation cycles are not clinically relevant, the clinically
relevant number of cycles including a safety margin can be used when supported by risk assessment.
If a number of cycles other than 10 is applied, the test method given in Annex B shall be used but in a
revised version adapted to the alternative number of cycles.
4.4.3 Balloon deflation time
Determine the time required to deflate the balloon from the RBP as described in Annex C.
4.4.4 Balloon diameter to inflation pressure (balloon compliance)
Determine the relationship between the balloon diameter and the balloon inflation pressure as
described in Annex D.
ISO 10555-4:2023(E)
4.4.5 Crossing profile
Determine the crossing profile as described in Annex E.
NOTE The largest diameter over the effective length of the catheter, including the proximal balloon bond, is
evaluated when measuring the outside diameter (see ISO 10555-1).
4.4.6 Balloon removal
Demonstrate that the balloon can be removed without damage after inflation and deflation in
accordance with the procedure described in Annex F.
4.5 Information to be supplied with the catheter
Information supplied with the catheter shall fulfil the requirements of ISO 10555-1:2023, 6.3 and shall
also include the following information:
a) nominal size of the catheter, as designated in 4.3;
b) position(s) of detectable marker(s);
c) RBP of the balloon, expressed in kPa;
d) balloon inflation pressure, expressed in kPa, required to achieve the nominal balloon diameter(s);
e) guidewire, guide catheter or sheath or introducer compatibility and size recommendations
appropriate to the intended clinical use.
Units of measurement systems other than those specified in this document should additionally be given
if clinically relevant.
NOTE The crossing profile, expressed in mm, can be given.
ISO 10555-4:2023(E)
Annex A
(normative)
Test for rated burst pressure (RBP)
A.1 Principle
The catheter is connected via its hub or proximal end to a pressure generating device which is filled
with fluid for inflation. Pressure is applied at a rate that allows accurate detection of burst pressure
until catheter balloon leaks or bursts. The burst pressure is recorded, and the RBP of the balloon is
determined.
A.2 Apparatus
A.2.1 Recommended guidewire or equivalent.
A.2.2 Water bath, controlled at (37 ± 2) °C.
A.2.3 Leak detection mechanism, e.g. dye in test fluid, pressure drop monitor, flow rate monitor.
A.2.4 Timing mechanism, with specified accuracy of at least ±1 s.
A.2.5 Pressure generating device, fitted with a means of measuring pressure with an accuracy of
±5 % of the reported value while maintaining the inflation pressure and fitted with a male 6 % (Luer)
taper for leak proof connection to the catheter.
A.3 Reagent
Fluid for inflation, e.g. room temperature water or other justified clinically relevant media.
A.4 Test procedure
A.4.1 Fill the pressure generating device (A.2.5) with fluid f
...
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