EN ISO 7439:2011
(Main)Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)
ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)
It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen (ISO 7439:2011)
Diese Internationale Norm legt Anforderungen und Prüfungen für kupferhaltige Intrauterinpessare zur Empfängnisverhütung (en: intrauterine devices, IUD) zum Einmalgebrauch und ihre Einführinstrumente fest. Intrauterinpessare, die nur aus einem Kunststoffkörper bestehen oder deren erstrangiger Zweck die Freisetzung von Progestogenen ist, fallen nicht in den Anwendungsbereich dieser Norm. ANMERKUNG Einige Aspekte dieser Internationalen Norm können auch auf Arzneistoffe enthaltende Intrauterinpessare und nicht-kupferhaltige Intrauterinpessare angewendet werden.
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2011)
L'ISO 7439:2011 spécifie les exigences et essais relatifs aux dispositifs contraceptifs intra-utérins à usage unique contenant du cuivre et à leurs systèmes d'insertion.
Elle ne s'applique pas aux dispositifs intra-utérins ayant seulement un corps en plastique ni à ceux dont le but principal est la libération de progestatifs.
Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi (ISO 7439:2011)
Ta mednarodni standard določa zahteve in preskuse za intrauterine kontracepcijske pripomočke z bakrenimi nosilci (IUD) in njihove instrumente za vstavljanje. Ne velja za IUD, sestavljene samo iz plastičnega telesa, ali katerih glavni namen je sproščanje progestogenov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2011
1DGRPHãþD
SIST EN ISO 7439:2002/kprA1:2009
SIST EN ISO 7439:2009
,QWUDXWHULQLNRQWUDFHSFLMVNLSULSRPRþNL]EDNUHQLPQRVLOFHP=DKWHYHLQSUHVNXVL
,62
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO
7439:2011)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen
(ISO 7439:2011)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2011)
Ta slovenski standard je istoveten z: EN ISO 7439:2011
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
June 2011
ICS 11.200 Supersedes EN ISO 7439:2009
English Version
Copper-bearing contraceptive intrauterine devices -
Requirements and tests (ISO 7439:2011)
Dispositifs intra-utérins contenant du cuivre - Exigences, Kupferhaltige Intrauterinpessare zur Empfängnisverhütung
essais (ISO 7439:2011) - Anforderungen, Prüfungen (ISO 7439:2011)
This European Standard was approved by CEN on 31 May 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 7439:2011) has been prepared by Technical Committee ISO/TC 157 "Non-systemic
contraceptives and STI barrier prophylactics" in collaboration with 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 December 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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 7439:2009.
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.
For relationship with EU Directive, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7439:2011 has been approved by CEN as a EN ISO 7439:2011 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/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 the
New Approach Directive 93/42/EEC on medical devices.
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 clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4 1, 2, 3, 4, 6 refers to 1st indent of ER 1
5.1 1, 2, 3, 4 refers to 1st indent of ER 1
5.2 1, 2, 9.2 refers to 1st indent of ER 1
5.3.1 1, 2, 9.2 refers to 1st indent of ER 1
5.3.2 3, 4
5.3.3 1, 2 refers to 1st indent of ER 1
5.3.4 1, 2, 9.2 refers to 1st indent of ER 1
5.4 9.2, 12.7.1
5.5.1 5
5.5.2 4
5.6 4
5.7 3, 4
6 7.1, 7.2, 8.1
7.1 1, 2, 3, 4, 6, 8.1 refers to 1st indent of ER 1
7.6 2, 7.1, 7.2, 7.5
7.7 1, 2, 3, 4, 6, 6.a refers to 1st indent of ER 1
8 1, 2, 3, 4, 7.1, 7.2 refers to 1st indent of ER 1
9 8.3, 8.4, 8.5
10 5, 8.3, 8.6
11.1 13.1, 13.2
11.2 13.3 a), 13.3 c) to f), 13.3 m) The part of ER 13.3.a) relating to
the information on the authorized
representative is not addressed
in this International Standard.
11.3 13.3 a), 13.3 d) to f) The part of ER 13.3.a) relating to
the information on the authorized
representative is not addressed
in this International Standard.
11.4 13.3 a) and 13.3 b), 13.3 k), The part of ER 13.3.a) relating to
13.6 b), 13.6 e) and 13.6 f), the information on the authorized
13.6 k), 13.6.l) representative is not addressed
in this International Standard.
11.5 13.4, 13.6 a) and 13.6 b),
13.6 d), 13.6.e), 13.6 i),
13.6 k) to n)
ER 13.3.f) is only partly
addressed: safety issues.
13.6 h) is not addressed in this
International Standard.
13.6 q) is not addressed in this
International Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 7439
Second edition
2011-06-01
Copper-bearing contraceptive
intrauterine devices — Requirements and
tests
Dispositifs intra-utérins contenant du cuivre — Exigences, essais
Reference number
ISO 7439:2011(E)
©
ISO 2011
ISO 7439:2011(E)
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing 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
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Published in Switzerland
ii © ISO 2011 – All rights reserved
ISO 7439:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Intended performance.2
5 Design attributes .2
6 Materials .4
7 Design evaluation.4
8 Manufacturing and inspection .8
9 Sterilization .8
10 Packaging.8
11 Information to be supplied by the manufacturer .8
Bibliography.11
ISO 7439:2011(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 7439 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier
prophylactics.
1)
This second edition cancels and replaces the first edition (ISO 7439:2002), of which it constitutes a minor
revision.
1) ISO 7439:2002 was incorrectly given as being the “second” edition, but as it replaced a Technical Report,
ISO/TR 7439:1981, as such it was the first edition as an International Standard.
iv © ISO 2011 – All rights reserved
ISO 7439:2011(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 validated.
INTERNATIONAL STANDARD ISO 7439:2011(E)
Copper-bearing contraceptive intrauterine devices —
Requirements and tests
1 Scope
This International Standard specifies r
...
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