oSIST prEN ISO 14375:2022

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte - Anforderungen und Prüfungen (ISO 14375:2018)

Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais (ISO 14375:2018)

Le présent document spécifie les exigences de performances et les méthodes d’essai des emballages non refermables conçus pour être à l’épreuve des enfants. Le présent document est uniquement destiné à l’approbation de type (voir 3.5) et non à l’assurance de la qualité.

Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za otroke - Zahteve in preskušanje (ISO 14375:2018)

General Information

• Status: Not Published
• Public Enquiry End Date: 02-Jan-2023
• ICS: 11.120.01 - Pharmaceutics in general
• ICS: 55.020 - Packaging and distribution of goods in general
• ICS: 97.190 - Equipment for children
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 14-Oct-2022
• Due Date: 03-Mar-2023
• Completion Date: 04-Feb-2023
• Ref Project: prEN ISO 14375 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

Relations

• Revises: SIST EN 14375:2017 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
• Effective Date: 01-Dec-2022

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14375:2022
01-december-2022

Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za

otroke - Zahteve in preskušanje (ISO 14375:2018)

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements

and testing (ISO 14375:2018)
Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische
Produkte - Anforderungen und Prüfungen (ISO 14375:2018)

Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques -

Exigences et essais (ISO 14375:2018)
Ta slovenski standard je istoveten z: prEN ISO 14375
ICS:
11.120.01 Farmacija na splošno Pharmaceutics in general
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
97.190 Otroška oprema Equipment for children
oSIST prEN ISO 14375:2022 en,fr,de

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

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oSIST prEN ISO 14375:2022
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oSIST prEN ISO 14375:2022
INTERNATIONAL ISO
STANDARD 14375
First edition
2018-07
Child-resistant non-reclosable
packaging for pharmaceutical
products — Requirements and testing
Emballages à l'épreuve des enfants, non refermables pour produits
pharmaceutiques — Exigences et essais
Reference number
ISO 14375:2018(E)
ISO 2018
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oSIST prEN ISO 14375:2022
ISO 14375:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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oSIST prEN ISO 14375:2022
ISO 14375:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General requirements ....................................................................................................................................................................... 2

4.2 Performance requirements .......................................................................................................................................................... 2

4.2.1 Child test ................................................................................................................................................................................. 2

4.2.2 Adult test................................................................................................................................................................................. 2

5 Testing ............................................................................................................................................................................................................................. 2

5.1 Principle ........................................................................................................................................................................................................ 2

5.2 Samples and sample preparation ........................................................................................................................................... 3

5.3 Procedure .................................................................................................................................................................................................... 3

5.3.1 General...................................................................................................................................................................................... 3

5.3.2 Child test ................................................................................................................................................................................. 3

5.3.3 Adult test................................................................................................................................................................................. 4

5.4 Evaluation .................................................................................................................................................................................................... 5

5.4.1 Child test ................................................................................................................................................................................. 5

5.4.2 Adult test................................................................................................................................................................................. 6

5.5 Overall test result .................................................................................................................................................................................. 6

6 Test report ................................................................................................................................................................................................................... 7

6.1 General ........................................................................................................................................................................................................... 7

6.2 Child test ....................................................................................................................................................................................................... 7

6.3 Adult test ...................................................................................................................................................................................................... 7

6.4 Additional (optional) information to be recorded ................................................................................................... 8

6.5 Overall test result .................................................................................................................................................................................. 8

Annex A (informative) Guidance for persons supervising tests with children ........................................................9

Annex B (normative) Test charts ...........................................................................................................................................................................11

Annex C (informative) Suitability of the sequential procedures chosen .....................................................................13

Bibliography .............................................................................................................................................................................................................................14

© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 14375:2022
ISO 14375:2018(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 documents should be noted (see 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 (see 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 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.

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.

This document was prepared by the European Committee for Standardization (CEN) (as EN 14375) and

was adopted, under a special “fast-track procedure”, by Technical Committee ISO/TC 122, Packaging,

Subcommittee SC 3, Performance requirements and tests for means of packaging, packages and unit loads

(as required by ISO/TC 122).
There are no changes to the content of the EN 14375 document.
iv © ISO 2018 – All rights reserved
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oSIST prEN ISO 14375:2022
ISO 14375:2018(E)
Introduction

Child-resistant packaging is used to create a physical barrier between a child and a potentially

hazardous product. Various types of packaging are recognized as being child-resistant, based on

performance testing against standards for specific product categories and packaging types.

Since child-resistant packaging was introduced, the incidence of accidental ingestion of potentially

hazardous products by children under 5 years old has fallen. The degree to which this is due to the

use of child-resistant packaging as opposed to other factors, such as greater public awareness of the

hazards, is not easily assessed, but there is little doubt that child-resistant packaging has made a

positive contribution to the reduction.

The use of child-resistant packaging needs to be confined to those products that are potentially

hazardous, or for which any legislation makes its use mandatory, since, if used in other circumstances,

there could be confusion over the degree of hazard posed by the product.

In any case, proper labelling and information by the manufacturer is important for the safe use of the

product in the home.

Child-resistant packaging acts as the last line of defence if other barriers separating the child and

hazardous product have failed. However, it should be recognized that it is unrealistic to expect that any

functional packaging can be totally impossible for a child of 42 to 51 months inclusive to open and that

child-resistant packaging cannot be a substitute for other safety precautions.

There has been an increasing use of child-resistant packaging, therefore it is desirable to achieve

agreement on testing procedures in order to avoid confusion and misunderstanding in an area of great

importance to the safety of young children.

The on-going development of non-reclosable packaging offers a significant area for innovation in

packaging. The styles of non-reclosable packages can be wide-ranging in design.

This document aims to minimize the number of children “exposed to training” during panel testing.

Since the introduction of performance testing much has been learned about the use of children for

testing child-resistant packaging and attention has been focused on how the number of children

involved can be reduced. Future development of standards based on mechanical test methods is needed

to avoid unnecessary child panel testing and is essential in developing physical package attributes

useable by manufacturers.

Child-resistant packaging is only the last in a series of protective measures, and does not release

parents or guardians from their duty to keep medicinal products out of the reach of children.

© ISO 2018 – All rights reserved v
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oSIST prEN ISO 14375:2022
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oSIST prEN ISO 14375:2022
INTERNATIONAL STANDARD ISO 14375:2018(E)
Child-resistant non-reclosable packaging for
pharmaceutical products — Requirements and testing
1 Scope

This document specifies performance requirements and methods of test for non-reclosable packaging

that have been designated child-resistant. This document is intended for type approval only (see 3.5)

and is not intended for quality assurance purposes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
child-resistant package

package which is difficult for young children to open (or gain access to the contents), but which is

possible for adults to use properly
3.2
non-reclosable child-resistant package

child-resistant package (3.1) or part of a child-resistant package which, when all or part of the contents

have been removed, cannot be properly closed again
3.3
substitute product
inert substitute resembling the product it replaces
Note 1 to entry: This is sometimes referred to as a placebo product.
EXAMPLE Powder, tablets or liquids (uncoloured water), etc.
3.4
unit dose

discrete quantity of any product to be removed from its immediate packaging in its entirety

3.5
type approval

procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified

set of materials
© ISO 2018 – All rights reserved 1
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oSIST prEN ISO 14375:2022
ISO 14375:2018(E)
4 Requirements
4.1 General requirements

A non-reclosable child-resistant package, when tested in accordance with the requirements of this

document, shall be capable of providing a satisfactory degree of resistance to opening by children

(see 4.2.1) and a satisfactory level of accessibility to its contents by adults (see 4.2.2).

A non-reclosable child-resistant package, in addition to conforming to the performance requirements

specified in this document (see 4.2), shall be appropriate for the contents, provide mechanical

protection and function properly for the life of the content and packaging.

Manufacturers, component manufacturers, fillers and packers of such packages shall initiate and

operate procedures to control the quality of packaging materials so that type approved packaging is in

accordance with the requirements of this document.

NOTE ISO 9001 specifies requirements for quality management systems where organizations need to

demonstrate their capability of supplying conforming products to customers.
4.2 Performance requirements
4.2.1 Child test

An individual child test shall be considered a failure in relation to unit, strip or blister packages if within

10 min the child accesses more than 8 unit doses from the packaging provided.

When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1.3, the packaging shall be

deemed to be child-resistant.

NOTE The figure of eight units is based on existing national standards published by certain CEN members and

does not address the issue of toxicity. Some pharmaceutical products on the market can cause harm to children

by the ingestion of fewer than eight units. However, reliable data on child toxicity exists for few pharmaceutical

products. A harmful dose can be established for some existing pharmaceutical products and a maximum safe

dose can be established for all pharmaceutical products by one means or another. Such information is not

currently available for all products and there is no central register where this information could be held. In the

absence of European legislation on this topic, the drafters of EN 14375 acknowledge these concerns and believe

that research and collection of data should continue with a view to considering the substitution of a toxicity

based pass/fail criterion for the child panel test in a later revision.
4.2.2 Adult test

When tested in accordance with 5.3.3.2, at least 90 % of the adults shall be able to access at least 1 unit

dose within the 1 min test period, without a demonstration.

To minimize the exposure of children to unnecessary testing, the adult test should be carried out before

the child test.
5 Testing
5.1 Principle

Type approval for non-reclosable child-resistant packaging is obtained by a sequential test method or

full panel test for children and a full panel test for adults. A test group of up to 200 children aged 42 to

51 months is divided into pairs. Each child is given a number of non-reclosable packages to be opened by

whatever means they wish to use. If a child fails to gain access within 5 min, the method of opening is

demonstrated by the supervisor and the child is given a further 5 min to open the package. The results

are recorded sequentially, as obtained. The package is deemed child-resistant if the trail of results on

the test charts passes into the acceptance zone or if at least 80 % of the children are unable to access

more than eight unit doses within 1
...