SIST EN ISO 8317:2016
(Main)Child-resistant packaging - Requirements and testing procedures for reclosable packages (ISO 8317:2015)
Child-resistant packaging - Requirements and testing procedures for reclosable packages (ISO 8317:2015)
This International Standard specifies performance requirements and test methods for reclosable
packages designated as resistant to opening by children.
Acceptance criteria are given for the packages when tested by specified methods. These methods not
only provide a measure of the effectiveness of the packaging in restricting access by children, but also
cover the accessibility to the contents by adults.
This International Standard is applicable to reclosable packages for any product intended to be exposed
or removed from the packaging in normal use.
This International Standard is intended for type approval only and is not intended for quality
assurance purposes.
Kindergesicherte Verpackungen - Anforderungen und Prüfverfahren für wiederverschließbare Verpackungen (ISO 8317:2015)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für wiederverschließbare Verpackungen fest, die Schutz gegen eine Öffnung durch Kinder bieten sollen.
Für Verpackungen, die einer Prüfung nach den festgelegten Verfahren unterzogen wurden, werden Annahmekriterien festgelegt. Diese Verfahren stellen nicht nur einen Maßstab für die Wirksamkeit dar, mit der die Verpackungen dem Zugriff durch Kinder widerstehen, sondern erstrecken sich auch auf die Erreichbarkeit des Packungsinhalts durch Erwachsene.
Dabei beziehen sich diese Verfahren auf wiederverschließbare Verpackungen für beliebige Erzeugnisse, die bei sachgemäßem Gebrauch dazu bestimmt sind, freigelegt oder der Verpackung entnommen zu werden.
Diese Internationale Norm dient lediglich der Typprüfung, ist also nicht für Zwecke der Qualitätssicherung gedacht.
Emballages à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages refermables (ISO 8317:2015)
ISO 8317:2015 spécifie les exigences de performance et méthodes d'essai relatives aux emballages refermables désignés comme résistants à l'ouverture par les enfants.
Des critères d'acceptation sont donnés pour les emballages lorsqu'ils sont soumis à l'essai selon des méthodes spécifiques. Ces méthodes permettent non seulement de mesurer l'efficacité de l'emballage à limiter l'accès par les enfants, mais couvrent aussi l'accessibilité au contenu par des adultes.
ISO 8317:2015 est applicable aux emballages refermables pour tout produit destiné à être exposé ou retiré de l'emballage dans des conditions normales d'utilisation.
ISO 8317:2015 s'applique à l'homologation de type seulement et n'est pas destinée à être utilisée à des fins d'assurance qualité.
Embalaža, varna za otroke - Zahteve in preskusni postopki za embalažo, ki jo je mogoče večkrat zapreti (ISO 8317:2015)
Ta mednarodni standard določa zahteve delovanja in preskusne postopke za embalažo, ki jo je mogoče večkrat zapreti, a hkrati preprečuje, da bi jo odpirali otroci.
Kriteriji za sprejem so podani za pakete, ki so preskušeni po določeni metodi. Te metode zagotavljajo merilo učinkovitosti embalaže v smislu omejevanja dostopa za otroke, poleg tega pa pokrivajo tudi dostopnost do vsebine s strani odraslih oseb.
Ta mednarodni standard velja za embalažo, ki jo je mogoče večkrat zapreti, in ki vsebuje kakršen koli izdelek, namenjen temu, da bi bil odprt ali odstranjen iz embalaže pri običajni uporabi.
Ta mednarodni standard je namenjen samo za odobritev vrste in ne za namene zagotavljanja kakovosti.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8317:2016
01-februar-2016
1DGRPHãþD
SIST EN ISO 8317:2005
SIST EN ISO 8317:2005/AC:2005
(PEDODåDYDUQD]DRWURNH=DKWHYHLQSUHVNXVQLSRVWRSNL]DHPEDODåRNLMRMH
PRJRþHYHþNUDW]DSUHWL ,62
Child-resistant packaging - Requirements and testing procedures for reclosable
packages (ISO 8317:2015)
Kindergesicherte Verpackungen - Anforderungen und Prüfverfahren für
wiederverschließbare Verpackungen (ISO 8317:2015)
Emballages à l'épreuve des enfants - Exigences et méthodes d'essai pour emballages
refermables (ISO 8317:2015)
Ta slovenski standard je istoveten z: EN ISO 8317:2015
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 ISO 8317:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8317:2016
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SIST EN ISO 8317:2016
EN ISO 8317
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 55.020 Supersedes EN ISO 8317:2004
English Version
Child-resistant packaging - Requirements and testing
procedures for reclosable packages (ISO 8317:2015)
Emballages à l'épreuve des enfants - Exigences et Kindergesicherte Verpackungen - Anforderungen und
méthodes d'essai pour emballages refermables (ISO Prüfverfahren für wiederverschließbare Verpackungen
8317:2015) (ISO 8317:2015)
This European Standard was approved by CEN on 17 October 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8317:2015 E
worldwide for CEN national Members.
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SIST EN ISO 8317:2016
EN ISO 8317:2015 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 8317:2016
EN ISO 8317:2015 (E)
European foreword
This document (EN ISO 8317:2015) has been prepared by Technical Committee ISO/TC 122
"Packaging" in collaboration with 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 8317:2004.
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, 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.
Endorsement notice
The text of ISO 8317:2015 has been approved by CEN as EN ISO 8317:2015 without any modification.
3
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SIST EN ISO 8317:2016
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SIST EN ISO 8317:2016
INTERNATIONAL ISO
STANDARD 8317
Third edition
2015-11-01
Child-resistant packaging —
Requirements and testing procedures
for reclosable packages
Emballages à l’épreuve des enfants — Exigences et méthodes d’essai
pour emballages refermables
Reference number
ISO 8317:2015(E)
©
ISO 2015
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Requirements . 2
3.1 Test requirements . 2
3.1.1 General. 2
3.1.2 Evaluation of a series of similar packaging . 3
3.2 Test panels . 4
3.3 Performance requirements . 4
3.3.1 Requirements concerning children . 4
3.3.2 Requirements concerning adults . 4
4 Test procedures . 6
4.1 Test supervision . 6
4.2 Sample packages . 7
4.3 Preliminary checking and preparation . 7
4.4 Child test . 7
4.4.1 Guidance for persons supervising tests . 7
4.4.2 Composition of test group . 8
4.4.3 Test location . 8
4.4.4 Procedure . 8
4.4.5 Expression of results (see also 5.1) . 9
4.5 Adult test (50 years to 70 years old inclusive) . 9
4.5.1 General. 9
4.5.2 Composition of test group . 9
4.5.3 Procedure . 9
4.5.4 Expression of results (see also 5.2) .10
5 Assessment of results .10
5.1 Child test .10
5.1.1 Success/failure .10
5.1.2 Sequential method .10
5.1.3 Full test .11
5.2 Adult test .11
5.3 Overall test result .11
6 Test report .11
6.1 General .11
6.2 Child test .11
6.3 Adult test .12
6.4 Additional (optional) information to be recorded .12
6.5 Overall test result .12
Bibliography .13
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SIST EN ISO 8317:2016
ISO 8317:2015(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. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is 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).
This third edition cancels and replaces the second edition (ISO 8317:2003), which has been technically
revised. It also incorporates the Corrigenda, ISO 8317:2003/Corr 1:2005.
In addition to a number of editorial revisions, the following technical revisions have been made with
respect to the previous edition:
— introduction revised to remove historical discussion;
— definitions added for mechanical testing, mechanical test data, liner, essential characteristics, and
minor modifications (2.6 to 2.10)
— former Clauses 3 and 4 consolidated into new Clause 3 and subsequent clauses renumbered;
— requirements in previous edition 3.1, 3.2 and 4.2 not part of the testing, have been relocated and are
now informative. These are now included in the Introduction;
— introduction need to consider essential characteristics for a series of similar packaging (3.1.1);
— clarified instructions for evaluation of a series of similar packaging submitted at one time by
separation under component type (3.1.2.2, 3.1.2.3, 3.1.2.4);
— added new subclause on additions to a series and minor modifications (3.1.2.5);
— reference made to ISO 13127 (Introduction and 3.1.2.5);
— charts for sequential testing updated to correct errors (Figures 1 and 2);
— need to disable all (or any) incorporated tamper evident features before testing added (4.3);
— use of torque meter added for sample preparation of packages with torque dependent closures (4.3);
— deleted the limit (35 %) for the percentage of child tests administered by an individual tester (4.4.3);
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
— deleted the limit for number (30) of adults obtained from and tested at any one site, and number
(35) of adult tests administered by an individual tester (4.5.2).
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
Introduction
A significant number of suspected cases of ingestion by children of products used about the home are
reported to the medical profession each year. Most are not serious and those that are associated with
more serious side effects involve products known to be hazardous, e.g. certain medicinal products,
liquid fuels and solvents, strongly acid or alkaline preparations and some garden products. Most
commonly used household detergents, cleaning agents, and maintenance and care products are not
known to have caused injury. However, whether ingestion (actual or suspected) causes injuries or not,
such incidents can have traumatic effects on both the child and the parents.
The use of potentially hazardous agents in certain products is necessary to achieve effectiveness;
consequently steps have to be taken to limit the occurrence of accidents. One approach has been to
try to increase general awareness of hazards associated with various products. 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 should only be used for products as mentioned above
since, if used in other circumstances, it could lead to confusion among consumers. 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. The packaging functions as a last defence if other barriers separating children
and hazardous products have failed. Hence, the overall responsibility rests with the parents or other
responsible adults.
For the assessment of minor modifications to packages previously tested according to ISO 8317,
[1]
ISO 13127 describes appropriate methodology that may be used.
Attention is drawn to the need to have adequate supervisory and accreditation bodies, please see
[2]
ISO/IEC 17025, which provides useful guidance on these topics.
In addition to child resistant reclosable packages meeting the requirements of this International
Standard, attention is drawn to the need for the relevant parties in the supply chain to ensure that
a) appropriate quality systems are in place to ensure that the child resistant packaging are correctly
manufactured and remain in compliance with this International Standard,
b) the life expectancy of the child resistant packaging exceeds the maximum expected number
of openings and correct closings which are likely to occur in practice, without resulting in
unacceptable impairment of the child resistant property or function, and
c) the package meets the requirements of packaging, such as being appropriate for, and compatible
with, the contents, providing mechanical protection and functioning properly for the life of the
package in the intended geographical regions and climatic conditions.
NOTE Certain products can affect the physical or mechanical properties of a packaging system which
can lead to a loss of the child resistant function over time. In such a case, the packaging might not remain in
compliance with this International Standard. Compatibility between the packaging and the contents needs to be
assessed using appropriate methodology.
ISO/TC 122/SC 3 do not see the changes made in this edition invalidating the classification of packages
certified as child resistant under the previous edition of this International Standard since the adult and
child panel tests remain unchanged.
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SIST EN ISO 8317:2016
INTERNATIONAL STANDARD ISO 8317:2015(E)
Child-resistant packaging — Requirements and testing
procedures for reclosable packages
1 Scope
This International Standard specifies performance requirements and test methods for reclosable
packages designated as resistant to opening by children.
Acceptance criteria are given for the packages when tested by specified methods. These methods not
only provide a measure of the effectiveness of the packaging in restricting access by children, but also
cover the accessibility to the contents by adults.
This International Standard is applicable to reclosable packages for any product intended to be exposed
or removed from the packaging in normal use.
This International Standard is intended for type approval only and is not intended for quality
assurance purposes.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
container
vessel of glass, metal, plastic or a combination of materials designed to provide appropriate packaging
for a product and having a neck finish suitable for the proper attachment of a closure
2.2
closure
cap or securing device of metal, plastic or a combination of materials designed to fit an appropriate
container providing a secure seal against environmental challenges
2.3
child-resistant packaging
package consisting of a container and appropriate closure which is difficult for young children
under the age of 52 months to open (or gain access to the contents), but which is not difficult for
adults to use properly
2.4
reclosable package
package which, after it has been initially opened, is capable of being reclosed with a similar degree of
security and is capable of being used a sufficient number of times to dispense the total contents without
loss of security
2.5
substitute product
inert substitute resembling the product it replaces
Note 1 to entry: Solid substitute products for child-resistant packages normally consist of powder, granules or
units of any similar shape and size, varying from 5 mm to 30 mm in any dimension, preferably of a neutral colour,
and not harmful in any way.
Note 2 to entry: Liquid substitute product is always uncoloured water.
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
2.6
mechanical testing
documented and reproducible test methods intended to measure the resistance of the relevant features
of a child resistant packaging system
2.7
mechanical test data
data generated by mechanical testing
Note 1 to entry: These data can be used for the verification of equivalency of a child resistant packaging system
to the type-approved package.
2.8
liner
medium used to form a seal between a closure and a container
2.9
essential characteristics
those elements, properties or attributes of the container/closure system that are critical for maintaining
the child resistant functionality
Note 1 to entry: See 3.1.1 for examples of essential characteristics.
2.10
minor modifications
changes that potentially have no significant effect on child resistant functionality
3 Requirements
3.1 Test requirements
3.1.1 General
Only new packages shall be submitted for testing.
The container and closure system tested shall be representative of those in normal use and shall include
any wad or liner, if this is an integral part of the closure system.
Packages may be tested individually or as part of a series of similar packaging submitted at the same time.
When testing a series of similar packaging, the requirements in 3.1.2 shall be applied.
In specifying a series of similar packaging, the following essential characteristics shall be taken into
consideration.
NOTE The following list of attributes does not claim to be exhaustive.
CR system
— push down and turn;
— squeeze and turn, etc.
Container
— critical dimensions;
— material: glass, metal, different polymers, etc.;
— shape: round, square, rectangular, oval, etc.;
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
— handling: handle position, handle design, etc.;
— thread: form, position;
— neck: position, orientation, design, etc.;
— rigidity.
Closure
— critical dimensions;
— material: metal, different polymers, etc.;
— shape: round, square, rectangular, oval, etc.;
— handling: external gripping feature;
— thread: form, position;
— sealing feature: wad-liner, plug, etc.
3.1.2 Evaluation of a series of similar packaging
3.1.2.1 Rationale
The rationale for a series of similar packaging, which discloses the degree of commonality, shall be
recorded.
3.1.2.2 Closures
If a series of closures differ only in diameter, but are similar in all essential characteristics, where
the largest diameter is smaller than or equal to 1,5 times the smallest diameter, then the largest and
smallest size shall be tested.
If a series of closures differ only in diameter, but are similar in all essential characteristics, where the
largest diameter is greater than 1,5 times the smallest diameter, then the largest, smallest and one
intermediate size shall be tested.
EXAMPLE If the smallest diameter closure is 20 mm and the largest is no greater than 30 mm, test the
smallest and the largest sizes. If the smallest diameter closure is 20 mm and the largest is greater than 30 mm,
test the smallest, the largest and one intermediate size.
3.1.2.3 Containers
If the containers of the packaging differ only in capacity and the closures are identical, tests shall be
performed only on the largest and smallest container sizes.
3.1.2.4 Containers and closures
If the containers of the packaging differ only in capacity and the closures differ only in diameter but are
similar in all essential characteristics, the largest and smallest diameters of closure fitted to the largest
and smallest container shall be tested, this means normally four container/closure combinations
subject to the 1,5 times diameter rule given in 3.1.2.2.
If several container shapes are involved, but all other characteristics are the same and the closures are
identical or differ only in diameter, a selection from the range shall be made to test each body shape and
to ensure that at least four container/closure combinations are tested.
If all the packages specified in 3.1.2.2, 3.1.2.3 and 3.1.2.4 pass the test, containers and closures of
intermediate sizes in the same series shall be regarded as conforming to this International Standard.
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SIST EN ISO 8317:2016
ISO 8317:2015(E)
3.1.2.5 Additions and modifications
If, after a range of packaging has been tested and approved, sizes of containers and closures outside the
dimensions of the accepted range are to be added, the packages shall be tested as specified in 3.1.2.2,
3.1.2.3 and 3.1.2.4 to extend the range specified.
Minor modifications of container or closure can be evaluated by the development and provision of
mechanical test data showing compliance.
[1]
NOTE Test methods for mechanical testing of reclosable child resistant packaging are specified in ISO 13127.
Other modifications, which are outside the range of a series of similar packaging, shall be treated as a
separate series and tested accordingly.
3.2 Test panels
Testing shall be performed with two panels of people
a) a test with young children aged between 42 and 51 months old, inclusive,
b) a test with adults aged between 50 and 70 years old, inclusive.
3.3 Performance requirements
3.3.1 Requirements concerning children
3.3.1.1 Using a test panel of 200 children
When the package is tested in accordance with 4.4.4, the following requirements shall be met:
a) at least 85 % of the 200 children in the test panel shall be unable
...
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