SIST EN 862:2006
(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 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 nicht vom Anwendungsbereich
dieser Norm abgedeckt. Solche Verpackungen sind Gegenstand der separaten Norm EN 14375
Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte — Anforderungen
und Prüfungen.
Emballages - Emballage a l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques
Embalaža – Embalaža, varna za otroke – Zahteve in preskusni postopki za embalažo, ki je ni mogoče večkrat zapreti in ni za farmacevtske proizvode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 862:2006
01-februar-2006
1DGRPHãþD
SIST EN 862:2002
(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 a 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 862:2005
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 862:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 862:2006
---------------------- Page: 2 ----------------------
SIST EN 862:2006
EUROPEAN STANDARD
EN 862
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 55.020; 97.190 Supersedes EN 862:2001
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 14 October 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 862:2005: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 862:2006
EN 862:2005 (E)
Contents
Foreword.3
Introduction .4
1 Scope.5
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
2
---------------------- Page: 4 ----------------------
SIST EN 862:2006
EN 862:2005 (E)
Foreword
This document (EN 862:2005) has been prepared 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 May 2006, and conflicting national standards shall be
withdrawn at the latest by May 2006.
This document supersedes EN 862:2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia,
Spain, Sweden, Switzerland and United Kingdom.
3
---------------------- Page: 5 ----------------------
SIST EN 862:2006
EN 862:2005 (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 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 ----------------------
SIST EN 862:2006
EN 862:2005 (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 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.
2 Terms and definitions
For the purposes of this European standard, 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, i.e. 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 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
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).
5
---------------------- Page: 7 ----------------------
SIST EN 862:2006
EN 862:2005 (E)
A non-reclosable child-resistant package, in addition to conforming to the performance requirements
specified in this 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 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.
NOTE To minimise 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 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
6
---------------------- Page: 8 ----------------------
SIST EN 862:2006
EN 862:2005 (E)
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 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 shall be obtained before the child is used as a part of the test
group. Any children having been involved in a reported poisoning accident shall be excluded from the
test.
NOTE Children should be selected to represent, as closely as is reasonabl
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.