EN ISO 28862:2023
(Main)Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)
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)
Dieses Dokument legt Leistungsanforderungen an und Prüfverfahren für nichtwiederverschließbare Verpackungen fest, die als kindergesichert bezeichnet werden und die dafür vorgesehen sind, nicht-pharmazeutische Produkte zu enthalten. Dieses Dokument dient lediglich der Typprüfung (siehe 2.5) und nicht der Qualitätssicherung.
Dieses Dokument ist anwendbar für nichtwiederverschließbare Verpackungen vom Typ Einwegverpackungen, die aus einer oder mehreren einzelnen Einheiten bestehen.
Nichtwiederverschließbare Verpackungen für pharmazeutische Produkte sind vom Anwendungsbereich dieses Dokuments ausgeschlossen. Solche Verpackungen sind Gegenstand der separaten Norm ISO 14375, Child-resistant non-reclosable packaging for pharmaceutical products — Requirements and testing.
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)
Ta dokument določa zahteve glede učinkovitosti in preskusne metode za embalažo, ki je ni mogoče večkrat zapreti in je varna za otroke ter namenjena za shranjevanje nefarmacevtskih proizvodov. Ta dokument se uporablja samo za odobritev tipa (glej točko 2.5) in ne za namene zagotavljanja kakovosti.
Ta dokument se uporablja za embalažo za enkratno uporabo, ki je ni mogoče večkrat zapreti in je sestavljena iz ene ali več posameznih enot.
Embalaža, ki je ni mogoče večkrat zapreti, za farmacevtske proizvode je izključena s področja uporabe tega dokumenta. Ta je predmet ločenega standarda ISO 14375, Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za otroke – Zahteve in preskusni postopki.
Vsebina dokumenta standarda EN 862 ni bila spremenjena, razen dodane točke 2 – zveze s standardi.
General Information
Relations
Overview
EN ISO 28862:2023 - Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018) is a CEN-adopted ISO standard that specifies performance requirements and test methods for single‑use, non-reclosable packages designated as child‑resistant. The standard is intended for type approval of packaging designs (not for routine quality assurance) and excludes pharmaceutical packaging, which is covered by ISO 14375.
Key topics and technical requirements
- Scope and intent
- Applies to non-reclosable, single‑use packaging for non‑pharmaceutical products.
- Intended for type approval of child‑resistant packaging only.
- Performance testing
- Specifies child tests and adult tests to assess whether packaging resists opening by children but remains accessible to adults.
- Test procedures include sample selection, preparation, sequential test steps and defined evaluation criteria (see Clauses 4–5).
- Test programme and reporting
- Details required sample sizes, test procedures, evaluation methods, and test report contents (Clause 6).
- Includes annexes with guidance for supervising child tests, normative test charts and suitability notes on sequential procedures (Annexes A–C).
- Design and innovation considerations
- Encourages development of mechanical test methods and objective physical measurements to reduce reliance on child panel testing.
- Notes responsibility for correct labelling and that child‑resistant packaging is a last line of defense.
Practical applications and users
Who uses EN ISO 28862:2023:
- Packaging designers and manufacturers developing single‑use, non‑reclosable child‑resistant formats (e.g., household chemicals, hazardous consumer products).
- Regulatory bodies and conformity assessors requiring type approval evidence for market access in CEN member countries.
- Testing laboratories performing child and adult panel tests and preparing compliance test reports.
- Product safety engineers and brands seeking to demonstrate that packaging meets recognized international performance criteria.
Practical benefits:
- Provides a standardized pathway to demonstrate child resistance for non‑pharmaceutical products.
- Offers consistent test methods for international recognition and market acceptance.
- Supports innovation by recommending mechanical test development to complement or reduce human panel testing.
Related standards
- ISO 14375 - Child‑resistant non‑reclosable packaging for pharmaceutical products (separate standard for pharmaceuticals).
- ISO/TC 122 (Packaging) - technical committee responsible for packaging performance standards.
Keywords: EN ISO 28862:2023, child‑resistant packaging, non‑reclosable packages, testing procedures, packaging standards, type approval, non‑pharmaceutical products, performance requirements.
Frequently Asked Questions
EN ISO 28862:2023 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products (ISO 28862:2018)". This standard covers: 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.
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.
EN ISO 28862:2023 is classified under the following ICS (International Classification for Standards) categories: 55.020 - Packaging and distribution of goods in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 28862:2023 has the following relationships with other standards: It is inter standard links to EN 862:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 28862:2023 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
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: EN ISO 28862:2023
ICS:
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
97.190 Otroška oprema Equipment for children
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 28862
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 55.020
English Version
Packaging - Child-resistant packaging - Requirements and
testing procedures for non-reclosable packages for non-
pharmaceutical products (ISO 28862:2018)
Emballages - Emballage à l'épreuve des enfants - Verpackung - Kindergesicherte Verpackung -
Exigences et méthodes d'essai pour emballages non Anforderungen und Prüfverfahren für
refermables pour les produits non pharmaceutiques nichtwiederverschließbare Verpackungen für
(ISO 28862:2018) nichtpharmazeutische Produkte (ISO 28862:2018)
This European Standard was approved by CEN on 17 March 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 28862:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 28862:2018 has been prepared by Technical Committee ISO/TC 122 "Packaging” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 28862:2023 by
Technical Committee CEN/TC 261 “Packaging” the secretariat of which is held by AFNOR.
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 September 2023, and conflicting national standards
shall be withdrawn at the latest by September 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
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 28862:2018 has been approved by CEN as EN ISO 28862:2023 without any modification.
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
ISO 28862:2018(E)
© 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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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 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
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.
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
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
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