SIST EN ISO 10555-3:2013

SLOVENSKI STANDARD
SIST EN ISO 10555-3:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 10555-3:2000
SIST EN ISO 10555-3:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 3. del: Osrednji venski
katetri (ISO 10555-3:2013)
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous
catheters (ISO 10555-3:2013)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 3: Zentrale
venöse Katheter (ISO 10555-3:2013)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 3: Cathéters
veineux centraux (ISO 10555-3:2013)
Ta slovenski standard je istoveten z: EN ISO 10555-3:2013
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-3:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10555-3:2013

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

SIST EN ISO 10555-3:2013


EUROPEAN STANDARD
EN ISO 10555-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-3:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
3: Central venous catheters (ISO 10555-3:2013)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 3: Cathéters centraux veineux (ISO Verwendung - Teil 3: Zentrale venöse Katheter (ISO 10555-
10555-3:2013) 3:2013)
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 10555-3:2013: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

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

---------------------- Page: 4 ----------------------

SIST EN ISO 10555-3:2013
EN ISO 10555-3:2013 (E)
Foreword
This document (EN ISO 10555-3:2013) 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 10555-3:1997.
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 10555-3:2013 has been approved by CEN as EN ISO 10555-3:2013 without any modification.
3

---------------------- Page: 5 ----------------------

SIST EN ISO 10555-3:2013
EN ISO 10555-3:2013 (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 10555-3
7.3 4.1
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
12.9 4.2*
4.3*
13.1 4.1
13.2 4.1
13.3 a) 4.1
13.3 b) 4.1
4

---------------------- Page: 6 ----------------------

SIST EN ISO 10555-3:2013
EN ISO 10555-3:2013 (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
13.3 k) 4.1
4.5 d)
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 h 4.5 c)**
13.6 k) 4.1
13.6 l) 4.1
13.6 n) 4.1
13.6 q) 4.1
(*) Not applicable for the patient.
(**) The information is on cleaning even though it is not a reusable devices.

WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

5

---------------------- Page: 7 ----------------------

SIST EN ISO 10555-3:2013

---------------------- Page: 8 ----------------------

SIST EN ISO 10555-3:2013
INTERNATIONAL ISO
STANDARD 10555-3
Second edition
2013-06-15
Intravascular catheters — Sterile and
single-use catheters —
Part 3:
Central venous catheters
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 3: Cathéters centraux veineux
Reference number
ISO 10555-3:2013(E)
©
ISO 2013

---------------------- Page: 9 ----------------------

SIST EN ISO 10555-3:2013
ISO 10555-3:2013(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.
...