EN ISO 7439:2015

SLOVENSKI STANDARD
01-julij-2015
1DGRPHãþD
SIST EN ISO 7439:2011
,QWUDXWHULQLNRQWUDFHSFLMVNLSULSRPRþNL]EDNUHQLPQRVLOFHP=DKWHYHLQSUHVNXVL
,62
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO
7439:2015)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen und
Prüfungen (ISO 7439:2015)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2015)
Ta slovenski standard je istoveten z: EN ISO 7439:2015
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7439
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.200 Supersedes EN ISO 7439:2011
English Version
Copper-bearing contraceptive intrauterine devices -
Requirements and tests (ISO 7439:2015)
Dispositifs contraceptifs intra-utérins contenant du cuivre - Kupferhaltige Intrauterinpessare zur Empfängnisverhütung -
Exigences et essais (ISO 7439:2015) Anforderungen und Prüfungen (ISO 7439:2015)
This European Standard was approved by CEN on 13 September 2014.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2015 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 7439:2015) has been prepared by Technical Committee ISO/TC 157 "Non-systemic
contraceptives and STI barrier prophylactics" in collaboration Technical Committee CEN/TC 285 “Non-active
surgical implants” 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 October 2015, and conflicting national standards shall be withdrawn at
the latest by October 2015.
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 7439:2011.
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.
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 7439:2015 has been approved by CEN as EN ISO 7439:2015 without any modification.

INTERNATIONAL ISO
STANDARD 7439
Third edition
2015-02-15
Copper-bearing contraceptive
intrauterine devices —
Requirements and tests
Dispositifs contraceptifs intra-utérins contenant du cuivre —
Exigences et essais
Reference number
ISO 7439:2015(E)
©
ISO 2015
ISO 7439:2015(E)
© ISO 2015
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.
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Published in Switzerland
ii © ISO 2015 – All rights reserved

ISO 7439:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 2
4.1 General . 2
4.2 Clinical performance . 2
5 Design attributes . 2
5.1 General . 2
5.2 Shape . 2
5.3 Dimensions . 2
5.3.1 IUD . 2
5.3.2 Copper components . 2
5.3.3 Thread . 3
5.3.4 Insertion instrument . 3
5.4 Tensile force. 3
5.5 Stability . 3
5.5.1 Shelf-life stability . 3
5.5.2 In situ stability . 3
5.6 Visco-elastic property . 3
5.7 In situ detection . 3
6 Materials . 3
7 Design evaluation . 4
7.1 General . 4
7.2 Determination of dimensions . 4
7.3 Determination of tensile force . 4
7.3.1 Principle . 4
7.3.2 Apparatus . 4
7.3.3 Procedure . 4
7.3.4 Test report . 4
7.4 Test of visco-elastic property (memory test) . 5
7.4.1 Principle . 5
7.4.2 Procedure . 5
7.4.3 Test report . 5
7.5 Determination of barium sulfate content and identification of barium and sulfate . 5
7.5.1 Ash content test . 5
7.5.2 Identity test . 5
7.6 Pre-clinical evaluation . 6
7.7 Clinical evaluation . 6
8 Manufacturing and inspection . 7
9 Sterilization . 7
10 Packaging . 7
11 Information to be supplied by the manufacturer . 8
11.1 G
...