SIST EN ISO 10555-5:2013

SLOVENSKI STANDARD
SIST EN ISO 10555-5:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 10555-5:2000
SIST EN ISO 10555-5:2000/A1:2000
SIST EN ISO 10555-5:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 5. del: Periferni katetri z
notranjo iglo (ISO 10555-5:2013)
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral
catheters (ISO 10555-5:2013)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 5: Periphere
Katheter mit innen liegender Kanüle (ISO 10555-5:2013)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 5: Cathéters
périphériques à aiguille interne (ISO 10555-5:2013)
Ta slovenski standard je istoveten z: EN ISO 10555-5:2013
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-5:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-5:2013

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SIST EN ISO 10555-5:2013


EUROPEAN STANDARD
EN ISO 10555-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-5:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
5: Over-needle peripheral catheters (ISO 10555-5:2013)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 5: Cathéters périphériques à aiguille Verwendung - Teil 5: Periphere Katheter mit innen
interne (ISO 10555-5:2013) liegender Kanüle (ISO 10555-5:2013)
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 10555-5:2013: E
worldwide for CEN national Members.

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SIST EN ISO 10555-5:2013
EN ISO 10555-5:2013 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 10555-5:2013
EN ISO 10555-5:2013 (E)
Foreword
This document (EN ISO 10555-5:2013) 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 10555-5:1997.
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 10555-5:2013 has been approved by CEN as EN ISO 10555-5:2013 without any modification.
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SIST EN ISO 10555-5:2013
EN ISO 10555-5:2013 (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 10555-5
7.3 4.1
7.5 4.1
8.1 4.1
8.3 4.1
8.4 4.1
9.1 4.1
4.3.3.3
9.2 4.1
4.2
4.3.3.2
4.3.3.3
4.3.3.4
4.3.4
12.7.1 4.1
4.3.3.2
12.7.4 4.1
12.8.1 4.1
12.9 4.2
13.1 4.1
13.2 4.1
4

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SIST EN ISO 10555-5:2013
EN ISO 10555-5:2013 (E)
13.3 a) 4.1
13.3 b) 4.1
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
4.4 a) and c)
13.3 k) 4.1
4.4 b)
13.3 m) 4.1
13.4 4.1
13.6 a) 4.1
13.6 b) 4.1
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 10555-5:2013

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SIST EN ISO 10555-5:2013
INTERNATIONAL ISO
STANDARD 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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SIST EN ISO 10555-5:2013
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
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Tel. + 41 22 749 01 11
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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 10555-5:2013
ISO 10555-5:2013(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 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 iii

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SIST EN ISO 10555-5:2013
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: Gene
...