EN ISO 7439:2023
(Main)Copper-bearing contraceptive intrauterine devices - Requirements and tests (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
Relations
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: +41 22 749 01 11
Email: copyright@iso.org
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 . 9
8.5 Determination of barium sulfate content and identification of barium and sulfate . 9
8.5.1 Ash content test . 9
8.5.2 Identity test . 9
8.6 Pre-clinical evaluation . . 9
9 Manufacturing and inspection .10
10 Sterilization .10
iii
ISO 7439:2023(E)
11 Packaging.10
12 Information to be supplied by the manufacturer .10
12.1 General . 10
12.2 Labelling of the primary container . 11
12.3 Labelling of the secondary container . 11
12.4 Instructions for the health care providers . 11
12.5 Information intended for the client after insertion of the IUD .12
12.6 Written information intended for the client . 13
Annex A (normative) Sampling requirements for testing copper bearing IUDs .14
Bibliography .16
iv
ISO 7439:2023(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 document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and
STI barrier prophylactics, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 7439:2015), which has been technically
revised.
The main changes are as follows:
— the subclause on clinical performance has been revised (see 5.2);
— the movable collar has been added in the subclause on insertion instrument (see 6.3.4);
— requirements for packaging integrity have been added;
— the instructions for health care providers have been amended in accordance with the "Family
[4]
planning: A global handbook for providers" ;
— the requirement for stability in situ has been removed since there is no practical way of controlling
it.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 7439:2023(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.
The IUD is a highly effective contraceptive device with a long history of safe use. It can be used for many
years, with a prompt return of fertility upon removal.
IUDs do not prevent sexually transmitted infections and condom use is recommended for those at risk.
IUDs containing copper are regarded as single use sterile medical devices implanted in the uterus.
These medical devices are inserted and removed by trained and competent health care providers.
vi
INTERNATIONAL STANDARD ISO 7439:2023(E)
Copper-bearing contraceptive intrauterine devices —
Requirements and tests
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14630:2012, 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 information to be supplied by the manufacturer
— Part 1: General requirements
ASTM D 3078, Standard test method for determination of leaks in flexible packaging by bubble emission
ASTM F 1929standard test method for detecting seal leaks in porous medical packaging by dye penetration
1)
European Pharmacopoeia, (Ph. Eur.)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
contraceptive intrauterine device
IUD
copper-bearing device placed in the uterine cavity for the purpose of preventing pregnancy
1) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe.
ISO 7439:2023(E)
3.2
insertion instrument
instrument designed to place an IUD in the uterine cavity
3.3
thread
retrieval string attached to an IUD for the purposes of verifying the presence and facilitating the
removal by a trained health care provider
Note 1 to entry: 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
viscoelastic 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
3.6
lot
quantity of IUDs produced during essentially the same time using the same process, same lots of raw
materials, common equipment and which are sterilized at the same time
3.7
client
recipient or patient receiving a contraceptive product
3.8
unique device identifier
series of numeric or alphanumeric characters that is created through a globally accepted device
identification and coding standard
Note 1 to entry: The unique identifier might include information on the lot or serial number and be able to be
applied anywhere in the world. It allows the unambiguous identification of a specific medical device.
4 Quality verification
Copper bearing IUDs should be manufactured within an integrated quality management system
conforming to ISO 13485.
NOTE For most countries and regions, this is a regulatory requirement.
For quality verification purposes, the sample size requirements and acceptance criteria specified in
Annex A shall be used. These requirements are based on ISO 2859-1.
The sampling plans have been simplified to take into account typical industry lot sizes, the specific
characteristics of IUDs and the nature of the manufacturing processes used to produce them. The
sample sizes and acceptance criteria have been selected to provide an acceptable level of consumer
protection taking into account the costs of sampling and testing. In addition to verification testing, it
is strongly recommended that manufacturers conduct process validation and capability studies, and
adopt statistical process control procedures such as the use of control charts to ensure acceptable
product quality.
The sampling and acceptance criteria given in Annex A are intended to cover the following situations:
a) continuing production of lots within a stable manufacturing environment;
ISO 7439:2023(E)
b) the assessment of isolated lots (e.g. fewer than 5), for example when purchasers wish to conduct
confirmatory testing on a limited number of lots, when production is interrupted or intermittent,
or for surveillance testing.
In addition, the rules for switching between normal and tightened inspection in ISO 2859-1 have been
adopted to provide greater level of consumer protection should the quality of a manufacturing process
deteriorate. These rules are applied as follows:
— Normal inspection – the specified sample sizes for normal inspection apply at the start of production.
Normal inspection continues to apply unless two nonconforming lots are found in any sequence of
5 or fewer lots tested. If this occurs the number of samples used to assess the conformity for future
lots shall be increased to those specified for tightened inspection.
— Tightened inspection – the specified sample sizes for tightened inspection shall apply until a sequence
of 5 lots have been accepted. Following the acceptance of 5 sequential lots, the manufacturer may
return to the sample sizes for normal inspection.
The switch to reduced inspection has not been adopted for the testing of copper bearing IUDs. Switching
to smaller sample sizes is not considered acceptable given the potential for increased consumer risk
because of the small sample sizes specified under normal inspection for many of the tests.
5 Intended clinical performance
5.1 General
ISO 14630:2012, Clause 4, shall apply.
ISO 14155 shall apply.
5.2 Clinical performance
5.2.1 General
An IUD shall meet the requirements specified in 5.2.2.to 5.2.9, based on a single-arm clinical study
over a period of five years of user wear-time (the minimum intended lifetime of use). The manufacturer
shall present these data in a final report of the clinical evaluation before releasing a modified or newly
designed IUD onto the market.
[2]
NOTE 1 Guidance conducting a clinical study of Cu-IUDs is provided in ISO 11249 .
The IUD and IUD insertion instrument shall be carefully designed to work together. The clinical study
design shall ensure that the insertion instrument used in
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