EN ISO 7439:2023

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)

This document 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 or other medicinal products.
NOTE       Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen und Prüfungen (ISO 7439:2023)

Dieses Dokument legt Anforderungen und Prüfungen für kupferhaltige Intrauterinpessare zur Empfängnisverhütung (IUD) zum Einmalgebrauch und ihre Einführinstrumente fest.
Es gilt nicht für IUD, die nur aus einem Kunststoffkörper bestehen oder deren erstrangiger Zweck die Freisetzung von Progestogenen oder anderen Arzneimitteln ist.
ANMERKUNG   Einige Aspekte dieses Dokuments können auf Arzneimittel enthaltende Intrauterinpessare und nicht-kupferhaltige Intrauterinpessare angewendet werden.

Dispositifs contraceptifs intra-utérins contenant du cuivre - Exigences et essais (ISO 7439:2023)

Le présent document spécifie les exigences et essais relatifs aux dispositifs contraceptifs intra-utérins (DIU) à usage unique, contenant du cuivre, et à leurs systèmes d'insertion.
Il ne s'applique ni aux DIU constitués uniquement d'un corps en plastique ni à ceux dont le but principal est la libération de progestatifs ou d'autres médicaments.
NOTE       Certains aspects du présent document peuvent s'appliquer à des dispositifs intra-utérins libérant un agent contraceptif et à des dispositifs intra-utérins exempts de cuivre.

Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi (ISO 7439:2023)

Ta dokument določa zahteve in preskuse za intrauterine kontracepcijske pripomočke z bakrenim nosilcem (IUD) za enkratno uporabo ter instrumente za vstavljanje.
Ne uporablja se za maternične vložke, ki so sestavljeni samo iz plastičnega telesa ali katerih glavni namen je sproščanje progestagenov ali drugih medicinskih izdelkov.
OPOMBA: Nekatere vidike tega dokumenta je mogoče uporabljati za intrauterine pripomočke in maternične vložke z zdravilom, ki ne vsebujejo bakra.

General Information

• Status: Published
• Publication Date: 18-Apr-2023
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Apr-2023
• Completion Date: 19-Apr-2023
• Ref Project: SIST EN ISO 7439:2023 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2023)

Relations

• Replaces: EN ISO 7439:2015 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2023
Nadomešča:
SIST EN ISO 7439:2015
Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi
(ISO 7439:2023)
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO
7439:2023)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung - Anforderungen und
Prüfungen (ISO 7439:2023)
Dispositifs contraceptifs intra-utérins contenant du cuivre - Exigences et essais (ISO
7439:2023)
Ta slovenski standard je istoveten z: EN ISO 7439:2023
ICS:
11.200 Načrtovanje družine. Birth control. Mechanical
Mehanski kontracepcijski contraceptives
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 7439
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2023
EUROPÄISCHE NORM
ICS 11.200 Supersedes EN ISO 7439:2015
English Version
Copper-bearing contraceptive intrauterine devices -
Requirements and tests (ISO 7439:2023)
Dispositifs contraceptifs intra-utérins contenant du Kupferhaltige Intrauterinpessare zur
cuivre - Exigences et essais (ISO 7439:2023) Empfängnisverhütung - Anforderungen und Prüfungen
(ISO 7439:2023)
This European Standard was approved by CEN on 22 January 2023.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7439:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7439:2023) 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 October 2023, and conflicting national standards shall
be withdrawn at the latest by October 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7439:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 7439:2023 has been approved by CEN as EN ISO 7439:2023 without any modification.

INTERNATIONAL ISO
STANDARD 7439
Fourth edition
2023-04
Copper-bearing contraceptive
intrauterine devices — Requirements
and tests
Dispositifs contraceptifs intra-utérins contenant du cuivre —
Exigences et essais
Reference number
ISO 7439:2023(E)
ISO 7439:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 7439:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Quality verification . 2
5 Intended clinical performance . 3
5.1 General . 3
5.2 Clinical performance . 3
5.2.1 General . 3
5.2.2 Study duration . 3
5.2.3 Study population . 3
5.2.4 Sample size . 4
5.2.5 Contraceptive performance . 4
5.2.6 Expulsion rate . 4
5.2.7 Discontinuation rate . 4
5.2.8 Investigation report . 4
5.2.9 Labelling . 5
6 Design attributes .5
6.1 General . 5
6.2 Shape . 6
6.3 Dimensions . 6
6.3.1 IUD . 6
6.3.2 Copper components . 6
6.3.3 Thread . 6
6.3.4 Insertion instrument . 6
6.4 Tensile force . 6
6.5 Stability . 7
6.5.1 Shelf-life stability . 7
6.6 Viscoelastic property . 7
6.7 Detection by X-ray . 7
7 Materials . 7
8 Design evaluation . 7
8.1 General . 7
8.2 Determination of dimensions . 8
8.3 Determination of tensile force . 8
8.3.1 Principle . 8
8.3.2 Apparatus . 8
8.3.3 Procedure . 8
8.3.4 Test report . 8
8.4 Test of elastic recovery (memory test) . 9
8.4.1 Principle . 9
8.4.2 Procedure . 9
8.4.3 Test report .
...