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

This part of ISO 10555 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, Nichtaktive chirurgische Implantate  Allgemeine Anforderungen und ISO 12006

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
Published
Public Enquiry End Date
19-Jan-2012
Publication Date
08-Oct-2013
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Oct-2013
Due Date
06-Dec-2013
Completion Date
09-Oct-2013

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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
---------------------- Page: 2 ----------------------
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

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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, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 10555-4:2013 has been approved by CEN as EN ISO 10555-4:2013 without any modification.

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SIST EN ISO 10555-4:2013
EN ISO 10555-4:2013 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC

This European Standard has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC

amended by Directive 2007/47/EEC.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented

as a national standard in at least one Member State, compliance with the normative clauses of this standard given in

Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential

Requirements of that Directive.

NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC amended by

Directive 2007/47/EEC
Essential Requirements (ERs) of Directive Clause(s)/sub-clause(s) of this
93/42/EEC EN ISO 10555-4
7.3 4.1
4.4
7.5 4.1
8.1 4.1
8.3 4.1
8.4 4.1
9.1 4.1
9.2 4.1
4.2
4.3
4.4
12.7.1 4.1
4.4
12.7.4 4.1
12.8.1 4.1
13.1 4.1
4.5 a)
13.2 4.1
13.3 a) 4.1
13.3 b) 4.1
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SIST EN ISO 10555-4:2013
EN ISO 10555-4:2013 (E)
13.3 c) 4.1
13.3 d) 4.1
13.3 e) 4.1
13.3 f) 4.1
13.3 i) 4.1
13.3 j) 4.1
4.5 b), c), d) and e)
13.3 k) 4.1
13.3 m) 4.1
13.4 4.1
13.6 a) 4.1
13.6 b) 4.1
4.5 a), b) and c)
13.6 c) 4.1
13.6 e) 4.1
13.6 f) 4.1
13.6 g) 4.1
13.6 k) 4.1
13.6 l) 4.1
13.6 n) 4.1
13.6 q) 4.1

WARNING — Other requirements and other EU Directives may be applicable to the product(s)

falling within the scope of this standard.
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SIST EN ISO 10555-4:2013
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SIST EN ISO 10555-4:2013
INTERNATIONAL ISO
STANDARD 10555-4
Second edition
2013-06-15
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 10555-4:2013(E)
ISO 2013
---------------------- Page: 9 ----------------------
SIST EN ISO 10555-4:2013
ISO 10555-4:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013

All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
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SIST EN ISO 10555-4:2013
ISO 10555-4:2013(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 1

4.1 General ........................................................................................................................................................................................................... 1

4.2 Radio-detectability .............................................................................................................................................................................. 1

4.3 Designation of nominal size ......................................................................................................................................................... 1

4.4 Physical requirements ...................................................................................................................................................................... 2

4.5 Information to be supplied by the manufacturer ...................................................................................................... 2

Annex A (normative) Test for balloon rated burst pressure (RBP) ...................................................................................... 3

Annex B (normative) Balloon fatigue test for freedom from leakage and damage on inflation ............5

Annex C (normative) Test for balloon deflation time.......................................................................................................................... 7

Annex D (normative) Test for balloon diameter to inflation pressure ............................................................................. 9

Annex E (informative) Guidance on the selection of balloon materials........................................................................11

Bibliography .............................................................................................................................................................................................................................12

© ISO 2013 – All rights reserved iii
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SIST EN ISO 10555-4:2013
ISO 10555-4:2013(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International

Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies

casting a vote.

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.

ISO 10555-4 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal

products and intravascular catheters.

This second edition cancels and replaces the first edition (ISO 10555-4:1996), which has been technically

revised. It also incorporates the Technical Corrigendum ISO 10555-4:1996/Cor 1:2002.

ISO 10555 consists of the following parts, under the general title Intravascular catheters — Sterile and

single-use catheters:
— Part 1: General requirements
— Part 3: Central venous catheters
— Part 4: Balloon dilatation catheters
— Part 5: Over-needle peripheral catheters
The following part is under preparation:
— Part 6: Subcutaneous implanted ports

The following part has been withdrawn and the content has been included in ISO 10555-1:

— Part 2: Angiographic catheters

Attention is drawn to ISO 11070, which specifies requirements for accessory devices for use with

intravascular catheters, to ISO 25539-2 which specifies requirements for delivery systems if they

comprise an integral component of the deployment of the vascular stent, and to ISO 14630.

iv © ISO 2013 – All rights reserved
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SIST EN ISO 10555-4:2013
INTERNATIONAL STANDARD ISO 10555-4:2013(E)
Intravascular catheters — Sterile and single-use catheters —
Part 4:
Balloon dilatation catheters
1 Scope

This part of ISO 10555 specifies requirements for balloon dilatation catheters supplied in the sterile

condition, and intended for single use.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements
ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes,
...

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