SIST EN ISO 7439:2015

SLOVENSKI STANDARD
SIST EN ISO 7439:2015
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
SIST EN ISO 7439:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7439:2015

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SIST EN ISO 7439:2015

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.

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SIST EN ISO 7439:2015
EN ISO 7439:2015 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 7439:2015
EN ISO 7439:2015 (E)
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.


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SIST EN ISO 7439:2015

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SIST EN ISO 7439:2015
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

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SIST EN ISO 7439:2015
ISO 7439:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© 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.
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 2015 – All rights reserved

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SIST EN ISO 7439:2015
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 General . 8
11.2 Labelling of the primary container . 8
11.3 Labelling of the secondary container . 8
11.4 Instructions for use . 8
11.5 Information intended for the woman . 9
© ISO 2015 – All rights reserved iii

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SIST EN ISO 7439:2015
ISO 7439:2015(E)

Contents Page
Bibliography .11
iv © ISO 2015 – All rights reserved

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SIST EN ISO 7439:2015
ISO 7439:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
This third edition cancels and replaces the second edition (ISO 7439:2011), of which it constitutes a
minor revision.
© ISO 2015 – All rights reserved v

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SIST EN ISO 7439:2015
ISO 7439:2015(E)

Introduction
Although every foreign object in the uterus exhibits a certain contraceptive effect, the method by which
copper-bearing contraceptive intrauterine devices (IUDs) function is by the continuous release of copper
ions. This interferes with some enzymatic functions, immobilizes sperm cells and inhibits fertilization.
These contribute to the high effectiveness of the contraception.
The effectiveness of copper-bearing IUDs is many times greater than that of a simple plastics body.
Contraceptive IUDs containing copper are regarded as medical devices incorporating a substance
with an ancillary action and are subject to the European Council Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Contraceptive IUDs whose primary purpose is to release progestogens are regulated as medicinal
products and are subject to the European Council Directive 65/65/EEC of 26 January 1965 on the
approximation of provisions laid down by law, regulation or administrative action relating to proprietary
medicinal products. The relevant essential requirements of Annex I to Directive 93/42/EEC apply as far
as safety and performance-related device features are concerned. It is advisable that significant changes
in the design of the IUD, insertion device, specification or insertion technique be
...