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INTERNATIONAL
STANDARD
ISO
10555-5
Second edition
2013-06-15
Intravascular catheters — Sterile and
single-use catheters —
Part 5:
Over-needle peripheral catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 5: Cathéters périphériques à aiguille interne
Reference number
ISO 10555-5:2013(E)
© ISO 2013
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ISO 10555-5:2013(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 [email protected]
Web www.iso.org
Published in Switzerland
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© ISO 2013 – All rights reserved
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ISO 10555-5:2013(E)

Contents
Page
Foreword......................................................................................................................................................................................................................................... iv
1 Scope.................................................................................................................................................................................................................................. 1
2
3
Normative references....................................................................................................................................................................................... 1
Terms and definitions...................................................................................................................................................................................... 1
4 Requirements........................................................................................................................................................................................................... 2
4.1
General............................................................................................................................................................................................................ 2
4.2
Multilumen catheters......................................................................................................................................................................... 2
4.3
Physical requirements....................................................................................................................................................................... 3
4.4
Information to be supplied by the manufacturer....................................................................................................... 4
Annex A (normative) Determination of strength of union of needle hub and needle tube.......................... 5
Annex B (informative) Colours for opaque catheter hubs.............................................................................................................. 6
Annex C (informative) Needle point geometries....................................................................................................................................... 7
Annex D (normative) Determination of liquid leakage from vent fitting....................................................................... 8
Bibliography.............................................................................................................................................................................................................................. 10
© ISO 2013 – All rights reserved

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ISO 10555-5:2013(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 10555-5 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 10555-5:1996), which has been technically
revised. It also incorporates the Amendment ISO 10555-5:1996/Amd 1:1999 and the Technical
Corrigendum ISO 10555-5:1996/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, and to ISO 14972, which specifies requirements for sterile obturators for use
with over-needle peripheral catheters.
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