prEN ISO 10555-4

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO/DIS 10555-4:2022)

Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4: Ballondilatationskatheter (ISO/DIS 10555-4:2022)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters de dilatation à ballonnets (ISO/DIS 10555-4:2022)

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za širjenje žil (ISO/DIS 10555-4:2022)

General Information

• Status: Not Published
• Publication Date: 17-Dec-2024
• 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
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 09-Jun-2023
• Completion Date: 09-Jun-2023
• Ref Project: oSIST prEN ISO 10555-4:2023 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO/DIS 10555-4:2022)

Relations

• Revises: EN ISO 10555-4:2013 - Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
• Effective Date: 07-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 10555-4:2023
01-januar-2023
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 4. del: Balonski katetri za
širjenje žil (ISO/DIS 10555-4:2022)
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation
catheters (ISO/DIS 10555-4:2022)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 4:
Ballondilatationskatheter (ISO/DIS 10555-4:2022)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 4: Cathéters
de dilatation à ballonnets (ISO/DIS 10555-4:2022)
Ta slovenski standard je istoveten z: prEN ISO 10555-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 10555-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 10555-4:2023

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oSIST prEN ISO 10555-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2022-11-22 2023-02-14
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
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10555-4:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10555-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:

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
ICS: 11.040.25
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 10555-4:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
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 .18
iii
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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 medical
products and catheters.
This third edition cancels and replaces the second edition (ISO 10555-4:2013), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— Defined Rated Burst Pressure (RBP) (see 3.2).
— Defined crossing profile (see 3.3), added requirement (see 4.4.5), and created test method
(see Annex E).
— 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).
— Add requirement (see 4.4.6) and test method (see Annex F) for balloon removal without damage
after inflation and deflation.
— Added informative 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.
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.
iv
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
Introduction
To be developed, if necessary (not mandatory).
v
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oSIST prEN ISO 10555-4:2023

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oSIST prEN ISO 10555-4:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 10555-4:2022(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, 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 terminological 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
1
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
4 Requirements
4.1 General
Unless otherwise specified in this document, balloon dilatation catheters shall comply 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 Where a balloon dilation catheter is used as a stent delivery system, refer to the appropriate standard
for stents for designation of nominal size.
4.4 Physical requirements
4.4.1 Balloon rated burst pressure (RBP)
Determine the RBP when tested in accordance with Annex A.
NOTE Longitudinal burst is the desirable balloon burst mode, though other modes may be acceptable with
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.
2
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(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,
should be evaluated when measuring the outside diameter (see ISO 10555-1).
4.4.6 Balloon removal
Demonstrate 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:####, 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.
NOTE 1 Units of measurement systems other than those specified in this document can additionally be given.
NOTE 2 The crossing profile, expressed in mm, can be given.
3
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(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 for inflation (A.3).
A.4.2 The following steps of A.4.2 may be completed in any order.
A.4.2.1 Replace the air in the balloon catheter with fluid for inflation by applying vacuum and
allowing the fluid for inflation to return in place of the air. A small amount of air remaining, indicative
of normal use, is acceptable.
A.4.2.2 If the instructions for use specify that a guidewire should be used during balloon inflation,
insert the appropriate guidewire (A.2.1) in the device.
A.4.2.3 Connect the pressure generating device to the catheter under test and immerse at least the
balloon portion(s) in the water bath (A.2.2) at (37 ± 2) °C.
A.4.3 Allow the immersed portion of the catheter to equilibrate for a minimum of 2 min.
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oSIST prEN ISO 10555-4:2023
ISO/DIS 10555-4:2022(E)
A.4.4 Inflate the balloon using a pre-determined pressure profile versus time that will allow accurate
detection of burst pressure until the catheter bursts or fails. Record the burst pressure, burst mode and
location of the burst.
A.4.5 Calculate the RBP.
A.5 Test report
The test report shall include the following information:
a) identity of the catheter (e.g. description, lot, part number etc.);
b) reference to this document (including its year of publication) and annex;
c) mean, maximum, minimum and standard deviation of the burst pressure, expressed in kilopascals;
d) RBP, expressed in kilopascals;
e) all observed burst modes (e.g. longitudinal burst, bond leak etc.) and locations and whether
fragments were produced;
f) any deviations from the procedure;
g) the date of test.
Units of measurement systems other than those specified in this document should additionally be given
when clinically relevant.
5
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oSIST prEN ISO 1055
...