SIST EN 862:2017
(Main)Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
This European Standard 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 standard is intended for type approval only (2.5) and is not intended for quality assurance purposes.
This European Standard 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 standard. These are the subject of a separate standard, EN 14375 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing.
Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte
Diese Europäische Norm legt Leistungsanforderungen an und Prüfverfahren für nichtwiederverschließbare Verpackungen fest, die als kindergesichert bezeichnet werden und die dafür vorgesehen sind, nichtpharmazeutische Produkte zu enthalten. Diese Europäische Norm dient lediglich der Typprüfung (2.5) und nicht der Qualitätssicherung.
Diese Europäische Norm gilt für nichtwiederverschließbare Verpackungen vom Typ Einmalverpackungen, die aus einer oder mehreren einzelnen Einheiten bestehen.
Nichtwiederverschließbare Verpackungen für pharmazeutische Produkte sind ausgeschlossen vom Anwendungsbereich dieser Europäischen Norm. Solche Verpackungen sind Gegenstand der separaten Norm EN 14375, Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte — Anforderungen und Prüfungen.
Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques
La présente Norme européenne spécifie les exigences de performances et les méthodes d'essais des emballages non refermables conçus pour être à l’épreuve des enfants et destinés à des produits non pharmaceutiques. La présente Norme européenne est uniquement destinée à l’approbation de type (2.5) et non à l’assurance qualité.
La présente Norme européenne s'applique aux emballages non refermables du type « à usage unique », avec une ou plusieurs doses unitaires.
Les emballages non refermables destinés aux produits pharmaceutiques sont exclus du domaine d’application de la présente Norme européenne. Ils constituent le sujet d’une norme séparée EN 14375, Emballage non refermable à l'épreuve des enfants 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
Ta evropski standard določa zahteve glede učinkovitosti in preskusne metode za embalažo, ki je ni mogoče večkrat zapreti in je varna za otroke ter je namenjena za shranjevanje nefarmacevtskih proizvodov. Ta standard je namenjen samo za odobritev tipa (2.5) in ne za namene zagotavljanja kakovosti.
Ta evropski standard se uporablja za embalažo, ki je ni mogoče večkrat zapreti, za enkratno uporabo, ki je sestavljena iz ene ali več posameznih enot.
Embalaža, ki je ni mogoče večkrat zapreti, za farmacevtske proizvode je izključena s področja uporabe tega standarda. Ti so predmet ločenega standarda EN 14375 Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za otroke - Zahteve in preskusni postopki.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 862:2017
01-marec-2017
1DGRPHãþD
SIST EN 862:2006
(PEDODåD(PEDODåDYDUQD]DRWURNH=DKWHYHLQSUHVNXVQLSRVWRSNL]D
HPEDODåRNLMHQLPRJRþHYHþNUDW]DSUHWLLQQL]DIDUPDFHYWVNHSURL]YRGH
Packaging - Child-resistant packaging - Requirements and testing procedures for non-
reclosable packages for non-pharmaceutical products
Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für
nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte
Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour
emballages non refermables pour les produits non pharmaceutiques
Ta slovenski standard je istoveten z: EN 862:2016
ICS:
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
97.190 Otroška oprema Equipment for children
SIST EN 862:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 862:2017
---------------------- Page: 2 ----------------------
SIST EN 862:2017
EN 862
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2016
EUROPÄISCHE NORM
ICS 55.020; 97.190 Supersedes EN 862:2005
English Version
Packaging - Child-resistant packaging - Requirements and
testing procedures for non-reclosable packages for non-
pharmaceutical products
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
nichtpharmazeutische Produkte
This European Standard was approved by CEN on 27 May 2016.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 862:2016 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 862:2017
EN 862:2016 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 4
2 Terms and definitions . 5
3 Requirements . 5
4 Testing . 6
5 Test report . 10
Annex A (informative) Guidance for persons supervising tests with children . 13
Annex B (normative) Test charts . 14
Annex C (informative) Suitability of the sequential procedures chosen . 17
Bibliography . 18
2
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SIST EN 862:2017
EN 862:2016 (E)
European foreword
This document (EN 862:2016) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the
secretariat of which is held by AFNOR.
The document has been revised from edition EN 862:2005 to correct Clause 4.4.1.3.1.
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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 862:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
3
---------------------- Page: 5 ----------------------
SIST EN 862:2017
EN 862:2016 (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 European Standard 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 EN or national standards should be pursued as a means of reducing the reliance on child panel
testing.
1 Scope
This European Standard 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 European standard is intended for type approval only (2.5) and is not
intended for quality assurance purposes.
4
---------------------- Page: 6 ----------------------
SIST EN 862:2017
EN 862:2016 (E)
This European Standard 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 European
standard. These are the subject of a separate standard, EN 14375, Child-resistant non-reclosable
packaging for pharmaceutical products - Requirements and testing.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
child-resistant package
package which is difficult for young children to open (or gain access to the contents), but which it is
possible for adults to use properly
2.2
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
2.3
substitute product
inert substitute resembling the product it replaces
EXAMPLE Powder, tablets or liquids (uncoloured water), etc.
2.4
unit
discrete quantity of any product to be removed from its immediate packaging in its entirety
2.5
type approval
procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified
set of materials, which has met the requirements of this European standard
2.6
single use package
package of one or several units which are not only individually protected but also individually packed
for single use
3 Requirements
3.1 General requirements
A non-reclosable child-resistant package, when tested in accordance with the requirements of this
European Standard, shall be capable of providing a satisfactory degree of resistance to opening by
children (3.2.1). Accessibility to its contents by adults can be checked according to the optional adult
test (3.2.2).
A non-reclosable child-resistant package, in addition to conforming to the performance requirements
specified in this European Standard (3.2), shall be appropriate for the contents, provide mechanical
protection and function properly for the life of the content and packaging.
5
---------------------- Page: 7 ----------------------
SIST EN 862:2017
EN 862:2016 (E)
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 European Standard.
NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to
demonstrate their capability of supplying conforming products to customers.
3.2 Performance requirements
3.2.1 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 4.3.2 and evaluated in accordance with 4.4.1, the packaging shall be
child-resistant.
3.2.2 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 4.3.3 and evaluated in accordance with 4.4.2, 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.
4 Testing
4.1 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 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 one or more units within 10 min and at least
85 % of the children are unable to access one or more units within the first 5 min. The package’s
accessibility may also be assessed by an optional full panel test for adults using a test group of
100 adults. Each adult is given a non-reclosable package, any associated opening tools and written
instructions, and is allowed 5 min to familiarise themselves with the packaging. The number of adults
opening the package within a 1 min test period is recorded. The package is deemed to comply with the
requirements of this European Standard if at least 90 % of the adults are able to access at least 1 unit in
1 min.
4.2 Samples and sample preparation
Sufficient packages shall be produced by the proposed manufacturing process to enable a
representative sample to be selected by the supervisor for testing and to provide a reserve for reference
purposes. Dangerous products shall not be used to fill the package to be tested; an appropriate
substitute product shall be used. The material and design of the test samples shall conform to the
technical specification and they shall be representative of an average batch of original packages.
Packages for the child panel test shall be unprinted.
In every test, a new package shall be provided for each member of the test group.
6
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SIST EN 862:2017
EN 862:2016 (E)
Each sample package shall be checked for integrity before the test is conducted. The packages shall be
presented to the children without the outer retail packaging, giving them access to the individual units.
4.3 Procedure
4.3.1 General
The test procedure is carried out in two stages:
a) child test (4.3.2);
b) adult test (4.3.3).
4.3.2 Child test
4.3.2.1 Composition of child test group
The test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with
approximately equal numbers of girls and boys. As far as possible, there shall be an even distribution of
ages and sexes within the p
...
SLOVENSKI STANDARD
kSIST FprEN 862:2016
01-februar-2016
(PEDODåD(PEDODåDYDUQD]DRWURNH=DKWHYHLQSUHVNXVQLSRVWRSNL]D
HPEDODåRNLMHQLPRJRþHYHþNUDW]DSUHWLLQQL]DIDUPDFHYWVNHSURL]YRGH
Packaging - Child-resistant packaging - Requirements and testing procedures for non-
reclosable packages for non-pharmaceutical products
Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für
nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte
Emballages - Emballage à l'épreuve des enfants - Exigences et méthodes d'essai pour
emballages non refermables pour les produits non pharmaceutiques
Ta slovenski standard je istoveten z: FprEN 862
ICS:
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
97.190 Otroška oprema Equipment for children
kSIST FprEN 862:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN 862:2016
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kSIST FprEN 862:2016
FINAL DRAFT
EUROPEAN STANDARD
FprEN 862
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2015
ICS 55.020; 97.190 Will supersede EN 862:2005
English Version
Packaging - Child-resistant packaging - Requirements and
testing procedures for non-reclosable packages for non-
pharmaceutical products
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
nichtpharmazeutische Produkte
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the
Technical Committee CEN/TC 261.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN 862:2015 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
kSIST FprEN 862:2016
FprEN 862:2015 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Terms and definitions . 5
3 Requirements . 6
4 Testing . 6
5 Test report . 10
Annex A (informative) Guidance for persons supervising tests with children . 12
Annex B (normative) Test charts . 13
Annex C (informative) Suitability of the sequential procedures chosen . 16
Bibliography . 17
2
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kSIST FprEN 862:2016
FprEN 862:2015 (E)
European foreword
This document (FprEN 862:2015) has been prepared by Technical Committee CEN/TC 261 “Packaging”,
the secretariat of which is held by AFNOR.
This document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN 862:2005.
The document has been revised from edition EN 862:2005 to correct Clause 4.4.1.3.1.
3
---------------------- Page: 5 ----------------------
kSIST FprEN 862:2016
FprEN 862:2015 (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 European Standard 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 EN or national standards should be pursued as a means of reducing the reliance on child panel
testing.
4
---------------------- Page: 6 ----------------------
kSIST FprEN 862:2016
FprEN 862:2015 (E)
1 Scope
This European Standard 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 European standard is intended for type approval only (2.5) and is not
intended for quality assurance purposes.
This European Standard 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 European
standard. These are the subject of a separate standard, EN 14375, Child-resistant non-reclosable
packaging for pharmaceutical products - Requirements and testing.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
child-resistant package
package which is difficult for young children to open (or gain access to the contents), but which it is
possible for adults to use properly
2.2
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
2.3
substitute product
inert substitute resembling the product it replaces
EXAMPLE Powder, tablets or liquids (uncoloured water), etc.
2.4
unit
discrete quantity of any product to be removed from its immediate packaging in its entirety
2.5
type approval
procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified
set of materials, which has met the requirements of this European standard
2.6
single use package
package of one or several units which are not only individually protected but also individually packed
for single use
5
---------------------- Page: 7 ----------------------
kSIST FprEN 862:2016
FprEN 862:2015 (E)
3 Requirements
3.1 General requirements
A non-reclosable child-resistant package, when tested in accordance with the requirements of this
European Standard, shall be capable of providing a satisfactory degree of resistance to opening by
children (3.2.1). Accessibility to its contents by adults can be checked according to the optional adult
test (3.2.2).
A non-reclosable child-resistant package, in addition to conforming to the performance requirements
specified in this European Standard (3.2), 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 European Standard.
NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to
demonstrate their capability of supplying conforming products to customers.
3.2 Performance requirements
3.2.1 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 4.3.2 and evaluated in accordance with 4.4.1, the packaging shall be
child-resistant.
3.2.2 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 4.3.3 and evaluated in accordance with 4.4.2, 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.
4 Testing
4.1 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 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 one or more units within 10 min and at least
85 % of the children are unable to access one or more units within the first 5 min. The package’s
accessibility may also be assessed by an optional full panel test for adults using a test group of
100 adults. Each adult is given a non-reclosable package, any associated opening tools and written
instructions, and is allowed 5 min to familiarise themselves with the packaging. The number of adults
opening the package within a 1 min test period is recorded. The package is deemed to comply with the
6
---------------------- Page: 8 ----------------------
kSIST FprEN 862:2016
FprEN 862:2015 (E)
requirements of this European Standard if at least 90 % of the adults are able to access at least 1 unit in
1 min.
4.2 Samples and sample preparation
Sufficient packages shall be produced by the proposed manufacturing process to enable a
representative sample to be selected by the supervisor for testing and to provide a reserve for reference
purposes. Dangerous products shall not be used to fill the package to be tested; an appropriate
substitute product shall be used. The material and design of the test samples shall conform to the
technical specification and they shall be representative of an average batch of original packages.
Packages for the child panel test shall be unprinted.
In every test, a new package shall be provided for each member of the test group.
Each sample package shall be checked for integrity before the test is conducted. The packages shall be
presented to the children without the outer retail packaging, giving them access to the individual units.
4.3 Procedure
4.3.1 General
The test procedure is carried out in two stages:
a) child test (4.3.2);
b) adult test (4.3.3).
4.3.2 Child test
4.3.2.1 Composition of child test group
The test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with
approximately equal numbers of girls and boys. As far as possible, there shall be an even distribution of
ages and sexes within the panel. The children shall be selected at random and shall have no apparent
physical or mental disability that might affect manual dexterity. They shall not have taken part in more
than one previous test and, in that test, a
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