SIST EN 14375:2017

SLOVENSKI STANDARD
kSIST FprEN 14375:2016
01-februar-2016
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Child-resistant non-reclosable packaging for pharmaceutical products - Requirements
and testing
Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische
Produkte - Anforderungen und Prüfungen
Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques -
Exigences et essais
Ta slovenski standard je istoveten z: FprEN 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
kSIST FprEN 14375:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST FprEN 14375:2016


FINAL DRAFT
EUROPEAN STANDARD
FprEN 14375
NORME EUROPÉENNE

EUROPÄISCHE NORM

November 2015
ICS 11.120.99; 55.020; 97.190 Will supersede EN 14375:2003
English Version

Child-resistant non-reclosable packaging for
pharmaceutical products - Requirements and testing
Emballages à l'épreuve des enfants, non refermables Kindergesicherte, nichtwiederverschließbare
pour produits pharmaceutiques - Exigences et essais Verpackungen für pharmazeutische Produkte -
Anforderungen und Prüfung
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 14375:2015 E
worldwide for CEN national Members.

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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 6
5 Testing . 6
6 Test report . 11
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

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European foreword
This document (FprEN 14375:2015) 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 14375:2003.
Annexes A and C are informative.
Annex B is normative.
This document has been revised from EN 14375:2003 to correct Clause 5.4.1.3.1.
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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 European Standard 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.
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1 Scope
This European Standard specifies performance requirements and methods of test for non-reclosable
packaging that have been designated child-resistant. This European Standard is intended for type
approval only (see 3.5) and is not intended for quality assurance purposes.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
Not applicable.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
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
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
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, which has met the requirements of this European Standard
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4 Requirements
4.1 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 (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 European Standard (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 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.
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 this European Standard 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
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more than eight unit doses within 10 min and at least 85 % of the children are unable to access more
than eight unit doses within the first 5 min. The package’s accessibility by a test group of 100 adults is
also assessed. Each adult is given a non-reclosable package, any associated opening tools and written
instructions, and is allowed 5 min to familiarize 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
dose in 1 min.
5.2 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. For both the child and
adult tests, there shall be at least 10 unit doses available for each participant.
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 unit
doses.
5.3 Procedure
5.3.1 General
The test procedure is carried out in two stages:
a) child test (see 5.3.2);
b) adult test (see 5.3.3).
5.3.2 Child test
5.3.2.1 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 which might affect manual dexterity. They shall not have taken part in
more than one previous test and, in that test, a packaging of a different type and design shall have been
used. If a child is used for more than one test there shall be at least 4 weeks between tests. Parental or
guardian consent
...