prEN ISO 28862

Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)

This document specifies performance requirements and methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products. This document is intended for type approval only (see 2.5) and is not intended for quality assurance purposes.
This document applies to non-reclosable packages of the single-use type consisting of one or more individual units.
Non-reclosable packages for pharmaceutical products are excluded from the scope of this document. These are the subject of a separate standard, ISO 14375, Child-resistant non-reclosable packaging for pharmaceutical products — Requirements and testing.

Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte (ISO 28862:2018)

Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques (ISO 28862:2018)

Le présent document spécifie les exigences de performances et les méthodes d’essais des emballages non refermables revendiqués comme étant à l’épreuve des enfants et destinés à des produits non pharmaceutiques. Le présent document est uniquement destiné à l’approbation de type (voir 2.5), et non à l’assurance de la qualité.
Le présent document s’applique aux emballages non refermables à usage unique et contenant une ou plusieurs doses unitaires.
Les emballages non refermables destinés aux produits pharmaceutiques sont exclus du domaine d’application du présent document. Ils sont couverts par une norme séparée, à savoir l’ISO 14375, Emballages à l’épreuve des enfants, non refermables pour produits pharmaceutiques — Exigences et essais.

Embalaža - Embalaža, varna za otroke - Zahteve in preskusni postopki za embalažo, ki je ni mogoče večkrat zapreti in ni za farmacevtske proizvode (ISO 28862:2018)

General Information

• Status: Not Published
• Publication Date: 12-Nov-2024
• ICS: 55.020 - Packaging and distribution of goods in general
• Technical Committee: CEN/TC 261 - Packaging
• Drafting Committee: CEN/TC 261/SC 5/WG 27 - Child resistant packaging
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 16-Feb-2023
• Due Date: 09-Oct-2023
• Completion Date: 16-Feb-2023
• Ref Project: oSIST prEN ISO 28862:2022 - Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 28862:2022
01-december-2022
Embalaža - Embalaža, varna za otroke - Zahteve in preskusni postopki za
embalažo, ki je ni mogoče večkrat zapreti in ni za farmacevtske proizvode (ISO
28862:2018)

Packaging - Child-resistant packaging - Requirements and testing procedures for non-

reclosable packages for non-pharmaceutical products (ISO 28862:2018)
Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für
nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte (ISO
28862:2018)

Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour

emballages non refermables pour les produits non pharmaceutiques (ISO 28862:2018)

Ta slovenski standard je istoveten z: prEN ISO 28862
ICS:
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 28862:2022 en,fr,de

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

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oSIST prEN ISO 28862:2022
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oSIST prEN ISO 28862:2022
INTERNATIONAL ISO
STANDARD 28862
First edition
2018-07
Packaging — Child-resistant
packaging — Requirements and
testing procedures for non-reclosable
packages for non-pharmaceutical
products
Emballages — Emballage à l'épreuve des enfants — Exigences et
méthodes d'essai pour emballages non refermables pour les produits
non pharmaceutiques
Reference number
ISO 28862:2018(E)
ISO 2018
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oSIST prEN ISO 28862:2022
ISO 28862:2018(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 28862:2022
ISO 28862:2018(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

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

6.1 General ........................................................................................................................................................................................................... 6

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

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

6.4 Additional (optional) information to be recorded ................................................................................................... 7

6.5 Overall test result .................................................................................................................................................................................. 7

Annex A (informative) Guidance for persons supervising tests with children ........................................................8

Annex B (normative) Test charts ...........................................................................................................................................................................10

Annex C (informative) Suitability of the sequential procedures chosen .....................................................................12

Bibliography .............................................................................................................................................................................................................................13

© ISO 2018 – All rights reserved iii
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oSIST prEN ISO 28862:2022
ISO 28862:2018(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 862) 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 862 document apart from the addition of Clause 2,

Normative references.
iv © ISO 2018 – All rights reserved
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oSIST prEN ISO 28862:2022
ISO 28862:2018(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 this type of 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 this 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 has to 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.

This document aims to reduce 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 may

be reduced. Future development of standards based on mechanical test methods is required 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 potentially dangerous products out of the reach of 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.

Mechanical test methods may be used to generate test data for comparison and demonstration that the

notified packaging is as safe as the original reference one. Mechanical tests are test methods generating

data by destructive or non-destructive tests of a specific reference package having shown child-

resistant properties. Consequently, the development of mechanical test methods by manufacturers

allied to current standards should be pursued as a means of reducing the reliance on child panel testing.

© ISO 2018 – All rights reserved v
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oSIST prEN ISO 28862:2022
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oSIST prEN ISO 28862:2022
INTERNATIONAL STANDARD ISO 28862:2018(E)
Packaging — Child-resistant packaging — Requirements
and testing procedures for non-reclosable packages for
non-pharmaceutical products
1 Scope

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

that has been designated child-resistant and which is intended to contain non-pharmaceutical products.

This document is intended for type approval only (see 2.5) and is not intended for quality assurance

purposes.

This document applies to non-reclosable packages of the single-use type consisting of one or more

individual units.

Non-reclosable packages for pharmaceutical products are excluded from the scope of this document.

These are the subject of a separate standard, ISO 14375, Child-resistant non-reclosable packaging for

pharmaceutical products — Requirements and testing.
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 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
EXAMPLE Powder, tablets or liquids (uncoloured water), etc.
3.4
unit

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

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oSIST prEN ISO 28862:2022
ISO 28862:2018(E)
3.5
type approval

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

set of materials
3.6
single use package

package of one or several units which are not only individually protected but also individually packed

for single use
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

(4.2.1). Accessibility to its contents by adults can be checked according to the optional adult test (4.2.2).

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

specified in this document (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 a single use package if within 10 min,

or 5 min when no demonstration has been given, the child gains access to one or more units from the

packaging provided.

When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1, the packaging shall be

child-resistant.
4.2.2 Adult test

This test is optional unless a tool is supplied to open the container at the point of sale.

When tested in accordance with 5.3.3 and evaluated in accordance with 5.4.2, at least 90 % of the adults

shall be able to access at least 1 unit 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

for children. A test group of up to 200 children aged 42 to 51 months is divided into pairs. Each child

...