SIST EN ISO 7439:2009

SLOVENSKI STANDARD
SIST EN ISO 7439:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 7439:2002
SIST EN ISO 7439:2002/kprA1:2009
,QWUDXWHULQLNRQWUDFHSFLMVNLSULSRPRþNL]EDNUHQLPQRVLOFHP=DKWHYHSUHVNXVL
,62
Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO
7439:2002)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen, Prüfungen
(ISO 7439:2002)
Dispositifs intra-utérins contenant du cuivre - Exigences, essais (ISO 7439:2002)
Ta slovenski standard je istoveten z: EN ISO 7439:2009
ICS:
11.200 1DþUWRYDQMHGUXåLQH Birth control. Mechanical
0HKDQVNLNRQWUDFHSFLMVNL contraceptives
SULSRPRþNL
SIST EN ISO 7439:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7439:2009

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SIST EN ISO 7439:2009
EUROPEAN STANDARD
EN ISO 7439
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.200 Supersedes EN ISO 7439:2002
English Version
Copper-bearing intra-uterine contraceptive devices -
Requirements, tests (ISO 7439:2002)
Dispositifs intra-utérins contenant du cuivre - Exigences, Kupferhaltige Intrauterinpessare zur Empfängnisverhütung
essais (ISO 7439:2002) - Anforderungen, Prüfungen (ISO 7439:2002)
This European Standard was approved by CEN on 19 April 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2009: E
worldwide for CEN national Members.

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SIST EN ISO 7439:2009
EN ISO 7439:2009 (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 7439:2009
EN ISO 7439:2009 (E)
Foreword
The text of ISO 7439:2002 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 7439:2009 by
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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 7439:2002.
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 EC Directive.
For relationship with EC 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, 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 7439:2002 has been approved by CEN as a EN ISO 7439:2009 without any modification.
3

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SIST EN ISO 7439:2009
EN ISO 7439:2009 (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 Communities 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 European 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 7439:2009
EN ISO 7439:2009 (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 European 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 European 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 European 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
European Standard.
13.6 q) is not addressed in this
European 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 7439:2009

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SIST EN ISO 7439:2009

INTERNATIONAL ISO
STANDARD 7439
Second edition
2002-03-15

Copper-bearing intra-uterine contraceptive
devices — Requirements, tests
Dispositifs intra-utérins contenant du cuivre — Spécifications, essais




Reference number
ISO 7439:2002(E)
©
ISO 2002

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SIST EN ISO 7439:2009
ISO 7439:2002(E)
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ii © ISO 2002 – All rights reserved

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SIST EN ISO 7439:2009
ISO 7439:2002(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 7439 was prepared by the European Committee for Standardization (CEN) in
collaboration with Technical Committee ISO/TC 157, Mechanical contraceptives, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International Standard.".
This second edition cancels and replaces the first edition of ISO/TR 7439 (ISO/TR 7439:1981), which has been
technically revised.
Annex ZZ forms a normative part of this International Standard.
Annex ZZ provides a list of corresponding International and European Standards for which equivalents are not
given in the text.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives
has been removed.
© ISO 2002 – All rights reserved iii

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SIST EN ISO 7439:2009
ISO 7439:2002(E)
Contents
v
Foreword.
vi
Introduction
........................................................................................................................................................
1 Scope 1
......................................................................................................................................................
2 Normative references 1
...............................................................................................................................
3 Terms and definitions 1
...............................................................................................................................
4 Intended performance 2
..............................................................................................................................
5 Design attributes 2
......................................................................................................................................
6 Materials 3
..................................................................................................................................................
7 Design evaluation 3
.....................................................................................................................................
8 Manufacturing and inspection 7
..................................................................................................................
9 Sterilization 7
..............................................................................................................................................
10 Packaging 7
................................................................................................................................................
11 Information supplied by the manufacturer 7
.................................................................................................
Annex ZZ Corresponding International and European Standards for which equivalents are not given
10
in the text .
Bibliography 11
........................................................................................................................................................
iv © ISO 2002 – All rights reserved

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SIST EN ISO 7439:2009
ISO 7439:2002(E)
Foreword
This document (EN ISO 7439:2002) has been prepared by Technical Committee CEN/TC 285 "Non-active surgical


implants", the secretariat of which is held by NEN in collaboration with Technical Committee ISO/TC 157
"Mechanical contraceptives".
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 September 2002, and conflicting national standards shall be withdrawn at the
latest by September 2002.
This European Standard needs to be considered in conjunction with EN ISO 14630, which contains requirements that
apply to all non-active surgical implants. Although contraceptive intra-uterine devices are not implants, most of
surgical
the requirements of EN ISO 14630 may be applicable to contraceptive intra-uterine devices.
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).
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
© ISO 2002 – All rights reserved v

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SIST EN ISO 7439:2009
ISO 7439:2002(E)
Introduction
Although every object in the uterus exhibits a certain contraceptive effect, the method by which copper-bearing
foreign

intra-uterine contraceptive devices (IUDs) function is by the continuous release of copper ions. This interferes with
some enzymatic functions, immobilizes sperm cells and inhibits fertilization. In addition, growth and development of
the ovum, tubal function and implantation are inhibited and the biochemical environment of the uterus is altered. These
contribute to the high effectiveness of contraception.
The effectiveness of copper-bearing contraceptive intra-uterine devices is many times greater than that of a simple
plastics body.
Contraceptive intra-uterine devices containing copper are regarded as medical devices incorporating a substance with
an ancillary action and are subject to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Contraceptive intra-uterine devices whose primary purpose is to release progestogens are regulated as medicinal
products and are subject to 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.
vi © ISO 2002 – All rights reserved

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SIST EN ISO 7439:2009
ISO 7439:2002(E)
1 Scope
This European Standard applies to single-use copper-bearing intra-uterine contraceptive devices and their insertion

instruments. Intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive
devices whose primary purpose is to release progestogens are not included in the scope of this standard.
NOTE Some aspects of this standard can be applicable to medicated intra
...