SIST EN 862:2002
(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 the requirements and test methods for non-reclosable child-resistant packages designated as resistant to opening by children.
The standard applies to non-reclosable packages of the 'single-use' type of one or several individual units.
Non-reclosable packages for pharmaceutical products are excluded.
Acceptance criteria are given for the package when tested by specific methods. These methods do not only provide a measure of the effectiveness of the package but also cover the accessibility to the contents by adults.
This European Standard is intended for type approval only (see 4.1) and is not intended for quality assurance purposes.
NOTE The term 'non-reclosable child-resistant package' covers not only packages where the seal is provided by a system to prevent access by young children, designed for that purpose (for example, a package comprising separate compartments and including a supporting medium, pre-formed or not, which contains the product, along with a film material which constitutes the closure) but also those packages where there is no specific method of opening (for example, completely sealed sachets, etc.).
Verpackung - Kindergesicherte Verpackung - Anforderungen und Prüfverfahren für nichtwiederverschließbare Verpackungen für nichtpharmazeutische Produkte
Diese Europäische Norm legt Anforderungen und Prüfverfahren für nichtwiederverschließbare kindergesicherte Verpackungen fest, die Schutz gegen die Öffnung durch Kinder bieten sollen.
Diese Norm gilt für nichtwiederverschließbare Verpackungen, die für den "Einmal-Gebrauch" bestimmt sind und eine oder mehrere einzelne Einheiten enthalten.
Sie gilt nicht für nichtwiederverschließbare Verpackungen für pharmazeutische Produkte.
Für Verpackungen, die einer Prüfung nach den vorgeschriebenen Verfahren unterzogen wurden, werden Annahmekriterien vorgelegt. Diese Verfahren stellen nicht nur einen Maßstab für die Wirksamkeit dar, mit der die Verpackung dem Zugriff durch Kinder widersteht, sondern erstrecken sich auch auf die Erreichbarkeit des Packungsinhalts für den Erwachsenen.
Die vorliegende Europäische Norm sollte lediglich zur Typprüfung dienen (siehe 4.1), ist also nicht zur Qualitätssicherung gedacht.
ANMERKUNG Der Begriff ¿nichtwiederverschließbare kindergesicherte Verpackung" umfasst nicht nur Verpackungen,bei denen der Verschluss, um den Kindern den Zugang zu verwehren, als System vorgesehen ist (z.B. eine Verpackung,die mehrere Fächer umfasst, mit einem Trägermaterial, das vorgeformt sein kann, zur Aufnahme des Produkts, und einer Folie, die als Abdeckung dient), sondern auch solche Verpackungen, bei denen das Verfahren des Öffnens nicht eindeutig definiert, aber in gewisser Weise Bestandteil der Verpackung selbst ist (z.B. rundum versiegelte Beutelchen usw.).
Emballages - Emballage a l'épreuve des enfants - Exigences et méthodes d'essai pour emballages non refermables pour les produits non pharmaceutiques
La présente Norme européenne a pour objet de spécifier les exigences et les méthodes d'essais des emballages de protection non refermables considérés comme résistants à l'ouverture par les enfants.
Elle s'applique aux emballages non refermables du type "à usage unique", avec une ou plusieurs unités individuelles.
Les emballages non refermables destinés aux produits pharmaceutiques sont exclus.
Des critères d'acceptabilité sont donnés pour les emballages lorsqu'ils sont testés par des méthodes spécifiques. Ces méthodes permettent non seulement de mesurer l'efficacité de l'emballage, mais couvrent aussi l'accessibilité au contenu par des adultes.
La présente Norme européenne s'applique à l'approbation par type seulement (voir 4.1) et n'a pas pour but de déterminer l'assurance de la qualité.
NOTE Le terme "emballage de protection non refermable" recouvre à la fois les emballages dont la fermeture est assurée par un dispositif prévu à cet effet et dont la conception vise à empêcher les jeunes enfants d'accéder au produit qu'ils contiennent (par exemple, un conditionnement alvéolaire constitué d'un support, préformé ou non, recevant le produit, et d'un matériau pelliculaire constituant la fermeture) et les emballages qui n'ont pas de système d'ouverture spécifique (par exemple : sachets hermétiques, etc.).
Embalaža - Embalaža, varna za otroke - Zahteve in preskusni postopki za embalažo, ki se ne zapira ponovno in ni za farmacevtske proizvode
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2002
1DGRPHãþD
SIST EN 862:1998
Embalaža - Embalaža, varna za otroke - Zahteve in preskusni postopki za
embalažo, ki se ne zapira ponovno in ni za farmacevtske proizvode
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 862:2001
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.
EUROPEAN STANDARD
EN 862
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2001
ICS 55.020 Supersedes EN 862:1997
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 9 May 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, 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
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 862:2001 E
worldwide for CEN national Members.
Contents
page
Introduction .4
1 Scope .6
2 Normative references .6
3 Terms and definitions.6
4 General.7
4.1 Compliance with the European Standard.7
4.2 Packages for testing.7
5 Requirements .7
5.1 General safety requirements .7
5.2 Design requirements .7
5.3 Acceptance requirements.7
5.4 Child test.8
5.5 Adult test (optional) .9
6 Assessment of results.9
6.1 Child test.9
6.2 Sequential method.9
6.3 Adult test (optional) .10
6.4 Overall result .10
7 Test report .10
7.1 General.10
7.2 Child test.11
7.3 Adult test (optional) .11
7.4 Additional (option) information to be recorded.11
7.5 Overall test result.11
Annex A (normative) Tables for sequential test procedure .12
Annex B (normative) Charts for a sequential test procedure .20
Annex C (informative) Non-closable child-resistant packaging — Advice on providing opening
instructions.24
Annex D (informative) Guidance for persons supervising tests with children .25
Annex E (informative) Notes for guidance in adult testing .26
Bibliography .27
Foreword
This European Standard 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 January 2002, and conflicting national standards shall be withdrawn at the latest
by January 2002.
This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association
This European Standard supersedes EN 862:1997.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
Introduction
The use of potentially hazardous agents in certain products is necessary to achieve effectiveness. Consequently,
steps are taken to limit the occurrence of accidents. One approach has been to try to increase general awareness
of hazards associated with various products ; this approach has been used but public education aimed at protecting
the child by educating the parents and other adults about correct storage practices, etc., has never been
completely effective. Nevertheless, proper labelling and information by the manufacturer is important for the safe
use of products in the home.
Another approach has been the use of child-resistant packaging to put a physical barrier between the child and the
hazardous product. Such packaging could only be used for products as mentioned above since, if used in other
circumstances, it could lead to confusion among consumers. It has to be recognized that it is unrealistic to expect
that any functional packaging can be totally impossible for a child to open and this type of packaging cannot be a
substitute for normal safety precautions. The packaging functions acts as a last defence if other barriers separating
children and hazardous products have failed.
This standard is designed to meet the requirements of the Directive 67/548/EEC as amended for the fourteenth
time by Council Directive 91/410/EEC and complement the EN 28317 relating to child-resistant reclosable
packages. There are now around the world various types of packagings which are recognized as child-resistant
based on a test of the nature described. There is evidence that since these test methods were introduced the
incidence of ingestion by children of hazardous products has fallen. The degree to which this is due to the use of
child-resistant packaging against other factors, such as greater public awareness, is not easily assessed but there
is little doubt that child-resistant packaging has made a positive contribution.
Over the last decade 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. The development of
European Standards incorporating mechanical test methods based on current European or national standards is
appropriate to avoid unnecessary child panel testing and is essential in developing physical package attributes
usable by manufacturers.
Because of the increasing use of child-resistant packaging, it is desirable to achieve European agreement on
testing procedures in order to avoid confusion and misunderstanding in an area of great importance to the safety of
young children. A European Standard should also serve to reduce the number of children exposed to ‘training’
during panel testing. However, it should not be supposed that the provision of a standard method for assessing
child resistance is all that is needed either nationally or internationally. The test should be administered by some
responsible authority in each country adopting the European Standard, which should have confidence in the
manner in which testing is carried out and thus common procedures should be adopted by all administering
authorities covering such questions as :
how is it decided that a child-resistant packaging is needed ?
how is the test to be authorized and carried out ?
how and by whom will the results be evaluated and recorded ?
what minimum qualifications are required of supervisors who carry out the procedure ?
how is it ensured that no child takes part in more than two tests and then only on packagings that are
significantly different ?
how is it ensured that an identical package format is not tested more than once by different laboratories other
than for enforcement ?
Attention is drawn to the need to have adequate accreditation bodies. Evidence of conformity with this standard
may be certified only by laboratories which conform with European Standards Series EN 45000.
This European Standard has been prepared to specify requirements and testing procedures for child-resistant
packaging intended for potentially harmful products. It has been written as the best consensus which can be
achieved at present and should be reviewed in 2 years and revised if necessary in the light of experience.
NOTE 1 This European Standard refers only to accessibility to the contents of the package. Attention is drawn to the need,
when designing a child-resistant package, to give consideration to possible dangers linked to the risk of spillage which can
happen unexpectedly when opening or trying to open the package.
NOTE 2 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.
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.
NOTE 3 A fundamental change to the test period philosophy is applied because
there is a significant difference in the performance required from a non-reclosable packaging and ;
there is the difficulty in keeping the children motivated during a test period of 5 minutes.
NOTE 4 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.
A standard is in preparation to complement this EN 862.
1 Scope
This European Standard specifies the requirements and test methods for non-reclosable child-resistant packages
designated as resis
...
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