SIST 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)
This International Standard specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. 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 (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
SIST EN ISO 7439:2011
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
SIST EN ISO 7439:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7439:2011
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SIST EN ISO 7439:2011
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.
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SIST EN ISO 7439:2011
EN ISO 7439:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 7439:2011
EN ISO 7439:2011 (E)
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.
3
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SIST EN ISO 7439:2011
EN ISO 7439:2011 (E)
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
4
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SIST EN ISO 7439:2011
EN ISO 7439:2011 (E)
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.
5
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SIST EN ISO 7439:2011
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SIST EN ISO 7439:2011
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
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SIST EN ISO 7439:2011
ISO 7439:2011(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
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SIST EN ISO 7439:2011
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 2011 – All rights reserved iii
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SIST EN ISO 7439:2011
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
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SIST EN ISO 7439:2011
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.
© ISO 2011 – All rights reserved v
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SIST EN ISO 7439:2011
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SIST EN ISO 7439:2011
INTERNATIONAL STANDARD ISO 7439:2011(E)
Copper-bearing contraceptive intrauterine devices —
Requirements and tests
1 Scope
This International Standard specifies requirements and tests for single-use, copper-bearing contraceptive
intrauterine devices (IUDs) and their insertion instruments.
It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release
progestogens.
NOTE Some aspects of this International Standard can be applicable to medicated intrauterine devices and IUDs not
containing copper.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14630:2008, Non-active surgical implants — General requirements
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
2)
European Pharmacopoeia (Ph. Eur.)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
contraceptive intrauterine device
IUD
copper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy
2) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe.
© ISO 2011 – All rights reserved 1
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SIST EN ISO 7439:2011
ISO 7439:2011(E)
3.2
insertion instrument
instrument designed to place an IUD in the uterine cavity
3.3
thread
attachment to an IUD for the purposes of verifying the presence and enabling the removal of the IUD
NOTE The thread is intended to lie in the cervical canal and the vagina when the body of the device is placed
correctly in the uterine cavity.
3.4
visco-elastic property
property of an IUD enabling an approximate return to its initial configuration after deformation
3.5
active surface area
surface area of copper in the IUD that is intended to come into contact with uterine fluids
4 Intended performance
4.1 General
ISO 14630:2008, Clause 4, shall apply.
4.2 Clinical performance
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen (ISO/FDIS 7439:2011)Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO/FDIS 7439:2011)Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO/FDIS 7439:2011)11.200SULSRPRþNLBirth control. Mechanical contraceptivesICS:Ta slovenski standard je istoveten z:FprEN ISO 7439kSIST FprEN ISO 7439:2011en01-april-2011kSIST FprEN ISO 7439:2011SLOVENSKI
STANDARD
kSIST FprEN ISO 7439:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 7439
February 2011 ICS 11.200 Will supersede EN ISO 7439:2009English Version
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO/FDIS 7439:2011)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO/FDIS 7439:2011)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen (ISO/FDIS 7439:2011) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 285.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
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 worldwide for CEN national Members. Ref. No. FprEN ISO 7439:2011: EkSIST FprEN ISO 7439:2011
FprEN ISO 7439:2011 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST FprEN ISO 7439:2011
FprEN ISO 7439:2011 (E) 3 Foreword This document (FprEN 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 document is currently submitted to the Unique Acceptance Procedure. This document will supersede 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. Endorsement notice The text of ISO/FDIS 7439:2011 has been approved by CEN as a FprEN ISO 7439:2011 without any modification. kSIST FprEN ISO 7439:2011
FprEN ISO 7439:2011 (E) 4 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 EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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 kSIST FprEN ISO 7439:2011
FprEN ISO 7439:2011 (E) 5 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), 13.6 b), 13.6 e) and 13.6 f), 13.6 k), 13.6.l) The part of ER 13.3.a) relating to the information on the authorized 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.
kSIST FprEN ISO 7439:2011
kSIST FprEN ISO 7439:2011
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TOSUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICHTHEY ARE AWARE AND TO PROVIDE SUPPORT-ING DOCUMENTATION. IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-LOGICAL, COMMERCIAL AND USER PURPOSES,DRAFT INTERNATIONAL STANDARDS MAY ONOCCASION HAVE TO BE CONSIDERED IN THELIGHT OF THEIR POTENTIAL TO BECOME STAN-DARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
Reference numberISO/FDIS 7439:2011(E)© ISO 2011 FINAL DRAFT ISO/TC 157 Secretariat: DSM Voting begins on: 2011-02-10 Voting terminates on: 2011-04-10
INTERNATIONAL STANDARD ISO/FDIS7439Copper-bearing contraceptive intrauterine devices —Requirements and tests Dispositifs intra-utérins contenant du cuivre — Exigences, essais
kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to 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
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copyright@iso.org Web
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ii © ISO 2011 – All rights reserved
kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) © ISO 2011 – All rights reserved iii ISO/CEN PARALLEL PROCESSING This Minor Revision has been developed within the International Organization for Standardization (ISO), and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. This final draft is hereby submitted to a parallel two-month approval vote in ISO and three-month UAP vote in CEN. Positive votes shall not be accompanied by comments. Negative votes shall be accompanied by the relevant technical reasons.
In accordance with the provisions of Council Resolution 15/1993, this document is circulated in the English language only.
kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) iv © ISO 2011 – All rights reserved Contents Page Foreword.v Introduction.vi 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 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC.11 Bibliography.13
kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) © ISO 2011 – All rights reserved v 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. This second edition1) 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. kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) vi © ISO 2011 – All rights reserved 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. kSIST FprEN ISO 7439:2011
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 7439:2011(E) © ISO 2011 – All rights reserved 1 Copper-bearing contraceptive intrauterine devices — Requirements and tests 1 Scope This International Standard specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens. NOTE Some aspects of this International Standard can be applicable to medicated intrauterine devices and IUDs not containing copper. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements ISO 14630:2008, Non-active surgical implants — General requirements ISO 14971, Medical devices — Application of risk management to medical devices ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements European Pharmacopoeia (Ph. Eur.) 2) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 contraceptive intrauterine device IUD copper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy
2) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe. kSIST FprEN ISO 7439:2011
ISO/FDIS 7439:2011(E) 2 © ISO 2011 – All rights reserved 3.2 insertion instrument instrument designed to place an IUD in the uterine cavity 3.3 thread attachment to an IUD for the purposes of verifying the presence and enabling the removal of the IUD NOTE The thread is intended to lie in the cervical canal and the vagina when the body of the device is placed correctly in the uterine cavity. 3.4 visco-elastic property property of an IUD enabling an approximate return to its initial configuration after deformation 3.5 active surface area surface area of copper in the IUD that is intended to come into contact with uterine fluids 4 Intended performance 4.1 General ISO 14630:2008, Clause 4, shall apply. 4.2 Clinical performance An IUD shall meet the following requirements for a period of five years (the minimum intended lifetime of use): ⎯ the upper limit of the 95 % confidence level, two-sided confidence interval for the one-year pregnancy rate computed using life table methods shall be u 2 %; ⎯ one-year expulsion rates computed using life table methods shall be u 10 %; ⎯ one-year discontinuation rates computed using life table methods shall be u 35 %. 5 Design attributes 5.1 General ISO 14630:2008, Clause 5, shall apply. Thread and copper shall be integral parts of the IUD. 5.2 Shape When tested by visual and tactile
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