prEN ISO 7439

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO/DIS 7439:2022)

Kupferhaltige Intrauterinpessare zur Empfängnisverhütung – Anforderungen und Prüfungen (ISO/DIS 7439:2022)

Dispositifs contraceptifs intra-utérins contenant du cuivre - Exigences et essais (ISO/DIS 7439:2022)

Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi (ISO/DIS 7439:2022)

General Information

• Status: Not Published
• ICS: 11.200 - Birth control. Mechanical contraceptives
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 29-Sep-2022
• Completion Date: 29-Sep-2022
• Ref Project: oSIST prEN ISO 7439:2022 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO/DIS 7439:2022)

RELATIONS

• Revised: EN ISO 7439:2015 - Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
• Effective Date: 23-Dec-2020

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 7439:2022
01-junij-2022

Intrauterini kontracepcijski pripomočki z bakrenim nosilcem - Zahteve in preskusi

(ISO/DIS 7439:2022)

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO/DIS

7439:2022)
Kupferhaltige Intrauterinpessare zur Empfängnisverhütung – Anforderungen und
Prüfungen (ISO/DIS 7439:2022)

Dispositifs contraceptifs intra-utérins contenant du cuivre - Exigences et essais (ISO/DIS

7439:2022)
Ta slovenski standard je istoveten z: prEN ISO 7439
ICS:
11.200 Načrtovanje družine. Birth control. Mechanical
Mehanski kontracepcijski contraceptives
pripomočki
oSIST prEN ISO 7439:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 7439:2022
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oSIST prEN ISO 7439:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7439
ISO/TC 157 Secretariat: DSM
Voting begins on: Voting terminates on:
2022-04-14 2022-07-07
Copper-bearing contraceptive intrauterine devices —
Requirements and tests

Dispositifs contraceptifs intra-utérins contenant du cuivre — Exigences et essais

ICS: 11.200
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7439:2022(E)
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. © ISO 2022
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oSIST prEN ISO 7439:2022
ISO/DIS 7439:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
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Published in Switzerland
© ISO 2022 – All rights reserved
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oSIST prEN ISO 7439:2022
ISO/DIS 7439:2022(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 Study Duration ..................................................................................................................................................................... 3

5.2.2 Study Population ................................................................................................................................................................ 3

5.2.3 Sample size .............................................................................................................................................................................. 4

5.2.4 Contraceptive performance ...................................................................................................................................... 4

5.2.5 Expulsion rate ....................................................................................................................................................................... 4

5.2.6 Discontinuation rate ....................................................................................................................................................... 4

5.2.7 Investigation report ........................................................................................................................................................ 4

5.2.8 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

6.5.2 In situ stability ...................................................................................................................................................................... 7

6.6 Visco-elastic property ........................................................................................................................................... ........................... 7

6.7 In situ 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 visco-elastic property (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
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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 woman after insertion of the IUD ............................................................12

12.6 Written information intended for the woman ........................................................................................................ 13

Annex A (normative) Sampling requirements for testing copper bearing IUDs ...............................................14

Bibliography .............................................................................................................................................................................................................................16

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oSIST prEN ISO 7439:2022
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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 documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received. www.iso.org/patents

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT), see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 157, Non-systemic contraceptives and STI barrier

prophylactics.
This forth edition cancels and replaces the third edition (ISO 7439:2015).
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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 Cu-IUD is highly effective in the prevention of pregnancy. While in place in the uterus, its

effectiveness can last up to 12 years with no delay in the return of fertility once removed.

Copper-bearing intrauterine devices do not prevent sexually transmitted infections and condom use is

recommended for those at risk.

The effectiveness of copper-bearing IUDs is many times greater than that of a simple plastics body, with

duration of use up to 12 years.

Contraceptive IUDs containing copper are regarded as single use sterile medical devices implanted in

the uterus. These medical devices must be inserted by trained and competent Health Care Providers.

1) Less than 1 pregnancy per 100 women using an IUD over the first year (6 per 1,000 women who use the IUD

perfectly, and 8 per 1,000 women as commonly used). This means that 992 to 994 of every 1,000 women using IUDs

will not become pregnant.
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oSIST prEN ISO 7439:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 7439:2022(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 or other medicinal products.

NOTE Some aspects of this International Standard can be applicable to medicated intrauterine devices and

IUDs not containing copper.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by

acceptance quality limit (AQL) for lot-by-lot inspection

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 14630:2012, 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
European Pharmacopoeia, (Ph. Eur.)

ASTM D 3078standard 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

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

3.2
insertion instrument
instrument designed to place an IUD in the uterine cavity

2) European Directorate for the Quality of Medicines (EDQM) of the Council of Europe.

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3.3
thread

a retrieval string attached to an IUD for the purposes of verifying the presence and enabling the removal

of the IUD

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
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

3.6
lot

definite amount of IUDs produced during essentially the same time using the same process, same lots of

raw materials, common equipment and be sterilized at the same time
3.7
client
user or recipient or patient receiving a contraceptive product
3.8
UDI (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 may 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, Medical devices — Quality management systems — Requirements for

regulatory purposes for the manufacture of medical devices. 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, Sampling procedures for inspection

by attributes Part 1, Specification for sampling plans indexed by acceptable quality level (AQL) for lot-

by-lot inspection.

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.

b) The assessment of isolated lots (e.g. fewer than 5) for example when purchasers may wish to

conduct confirmatory testing on a limited number of lots, when production is interrupted or

intermittent, or for surveillance testing.
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In addition, the rules for switching between normal and tightened inspection in ISO 2859 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 14155:2020 shall apply.
5.2 Clinical performance

An IUD shall meet the following requirements, 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.

NOTE Guidance conducting a clinical study of Cu-IUDs is provided in ISO 11249, Copper-bearing intrauterine

contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies.

IUD and IUD insertion instrument

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 the study is the same (or very similar)

instrument that is marketed with or for the IUD.

NOTE Clinical validation for minor changes that don’t effect the safety and effectiveness of the insertion

device may not be necessary. Significant changes that might effect the safety and effectiveness may require a

new clinical validation.
5.2.1 Study Duration

The clinical study duration must be a minimum of five years, i.e. follow study subjects for a minimum of

five years of user wear-time. The duration must be as long as the proposed duration of use for the IUD

labelling.
5.2.2 Study Population

The clinical study population must comprise women who are at risk for pregnancy, i.e. women who

have regular unprotected heterosexual vaginal intercourse.
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5.2.3 Sample size

5.2.3.1 The study sample size shall be sufficient to yield 10,000 woman-months of use in the first year

of the clinical study.

5.2.3.2 The study sample size shall be sufficient to yield 200 women who fully complete a minimum

of five years of wear-time. Longer follow-up is required if a longer wear-time is specified.

5.2.3.3 For IUDs with innovative designs, i.e. different shapes, surface features or metallic

composition, the study sample size shall be sufficient to yield 20,000 woman-months of use in the first

year of the clinical study.

NOTE 1 This requirement applies to IUDs that are not equivalent to designs that have been subjected to

clinical validation.

NOTE 2 The developer of a new IUD should check with relevant regulatory bodies as to whether the new IUD

represents a innovative design that would be subject to the more stringent clinical study design requirements.

5.2.3.4 For IUDs with innovative designs, the study sample size shall be sufficient to yield 400 women

who fully complete five years of wear-time.

NOTE To account for IUD expulsions and IUD discontinuation in a single-arm, 5-year clinical study,

approximately 900–1 000 women should be enrolled. A statistical analysis should be undertaken to establish the

study sample size and the total number of women to be enrolled.
5.2.4 Contraceptive performance

For the first year of the clinical study, the upper limit of the 95 % confidence level, two-sided confidence

interval, for the one-year pregnancy rate computed using life table methods (ref 2 in the Bibliography)

shall be < 2 %. A one-year pregnancy rate shall be calculated by the same methodology for each

subsequent year of the study and shall meet the same performance target of < 2 %.

NOTE For clinical contraceptive studies, pregnancy is the obvious outcome of interest, but there are other

ways to analyse and present study results on effectiveness. Besides life-table analysis, some regulatory bodies

require alternate analyses, e.g. the Pearl Index. Before initiating a clinical study, a study sponsor is strongly

encouraged to consult with the relevant regulatory body that will review the study results.

5.2.5 Expulsion rate

For the first year of the clinical study, the one-year expulsion rate computed by life table methods shall

be < 10 %. A one-year expulsion rate shall be calculated by the same methodology for each subsequent

year of the study and meet the same performance target of upper limit of < 10 %.
5.2.6 Discontinuation rate

For the first year of the clinical study, the one-year discontinuation rate computed by life table methods

shall be < 35 %. A one-year discontinuation rate shall be calculated by the same methodology for each

subsequent year of the study and meet the same performance target of upper limit of < 35 %.

5.2.7 Investigation report

A Clinical Investigation Report on the clinical study shall be generated that provides all relevant clinical

information from the study. See ISO 14155, Clause 8.4 and Annex D. At a minimum, the report shall

present the following results:
Rates on the following:
— unintended pregnancies, specifying ectopic pregnancies;
© ISO 2022 – All rights reserved
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