SIST EN ISO 8317:2005

SLOVENSKI STANDARD
SIST EN ISO 8317:2005
01-marec-2005
1DGRPHãþD
SIST EN 28317:1996
SIST EN 28317:1996/AC:2004
(PEDODåDYDUQD]DRWURNH=DKWHYHLQSUHVNXVQLSRVWRSNL]DHPEDODåRNLMRMH
PRJRþHYHþNUDW]DSUHWL,62
Child-resistant packaging - Requirements and testing procedures for reclosable
packages (ISO 8317:2003)
Kindersichere Verpackung - Anforderungen und Prüfverfahren für wiederverschließbare
Verpackungen (ISO 8317:2003)
Emballages a l'épreuve des enfants - Exigences et méthodes d'essai pour emballages
refermables (ISO 8317:2003)
Ta slovenski standard je istoveten z: EN ISO 8317:2004
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 8317:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8317:2005

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SIST EN ISO 8317:2005
EUROPEAN STANDARD
EN ISO 8317
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2004
ICS 55.020 Supersedes EN 28317:1992
English version
Child-resistant packaging - Requirements and testing
procedures for reclosable packages (ISO 8317:2003)
Emballages à l'épreuve des enfants - Exigences et Kindersichere Verpackung - Anforderungen und
méthodes d'essai pour emballages refermables (ISO Prüfverfahren für wiederverschließbare Verpackungen (ISO
8317:2003) 8317:2003)
This European Standard was approved by CEN on 15 July 2004.
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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8317:2004: E
worldwide for CEN national Members.

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SIST EN ISO 8317:2005
EN ISO 8317:2004 (E)






Foreword



The text of ISO 8317:2003 has been prepared by Technical Committee ISO/TC 122 "Packaging”
of the International Organization for Standardization (ISO) and has been taken over as EN ISO
8317:2004 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 March 2005, and conflicting national
standards shall be withdrawn at the latest by March 2005.

This document supersedes EN 28317:1992.

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.


Endorsement notice

The text of ISO 8317:2003 has been approved by CEN as EN ISO 8317:2004 without any
modifications.

2

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SIST EN ISO 8317:2005

INTERNATIONAL ISO
STANDARD 8317
Second edition
2003-04-15


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 8317:2003(E)
©
ISO 2003

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SIST EN ISO 8317:2005
ISO 8317:2003(E)
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ii © ISO 2003 — All rights reserved

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SIST EN ISO 8317:2005
ISO 8317:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Terms and definitions. 1
3 General. 2
4 Requirements . 2
5 Test procedures . 6
6 Assessment of results. 9
7 Test report. 10
Bibliography . 12

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SIST EN ISO 8317:2005
ISO 8317:2003(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 8317 was prepared by Technical Committee 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 second edition cancels and replaces the first edition (ISO 8317:1989), which has been technically revised.

iv © ISO 2003 — All rights reserved

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SIST EN ISO 8317:2005
ISO 8317:2003(E)
Introduction
A significant number of suspected cases of ingestion by children of products used about the home is 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 do not appear on the list of products which have caused
injury. However, whether ingestion (actual or suspected) causes injuries or not, such incidents can have
traumatic effects on both the child and its 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; this approach has been used, but
public education aimed to protect the child by educating the parent 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 should 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 that this
type of packaging cannot be a substitute for normal safety precautions. The packaging functions as a last
defence if other barriers separating children and hazardous products have failed.
Historically, the United States of America was the first country to introduce a standard method of testing based
on the inability of 200 children of a specific age and sex distribution to open the package and the ability of
100 adults of a particular age and sex distribution to open and, where applicable, reclose the package
properly. Since then, a number of other countries have introduced standard test methods based on similar
principles. 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-restraint packaging as 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. So far, it has not
been possible to achieve an objective set of tests and criteria which would render the use of children in
subjective testing unnecessary, but work should be directed towards achieving this aim as a matter of some
urgency.
Because of the increasing use of child-restraint packaging, it is desirable to achieve international agreement
on testing procedures in order to avoid confusion and misunderstanding in an area of great importance to the
safety of young children. An International 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 has to
be administered by some responsible authority in each country adopting the International Standard, as all
have to have confidence in the manner in which testing is carried. 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?
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SIST EN ISO 8317:2005
ISO 8317:2003(E)
 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?
Attention is drawn to the need to have adequate supervisory and accreditation bodies, and reference should
be made to ISO/IEC Guide 23, Methods of indicating conformity with standards for third-party certification
systems, and ISO/IEC 17025:1999, General requirements for the competence of testing and calibration
laboratories, which provide useful guidance on these topics.
This International 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 more frequently than other International Standards and
revised in the light of experience.
NOTE 1 This International 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 Studies are at present being carried out to determine whether it is feasible to develop an International
Standard for non-reclosable packages and other International Standards may be published in future detailing mechanical
methods which may be suitable for regulatory and quality assurance purposes.
The rationale for the proposed amendments to ISO 8317:1989 is as follows.
The publication and adoption of ISO 8317:1989 has resulted in a wider use of reclosable child-resistant
packaging, which has enforced a growing awareness that the elderly and physically handicapped have
difficulty in opening this style of packaging.
This, on occasion, can result in the child-resistant closure not being properly reapplied. The US Consumer
Product Safety Commission (CPSC) has also recognized this concern and, in 1996, introduced amendments
to their adult test protocol.
ISO/TC 122/SC 3/WG 3, when reviewing ISO 8317:1989, considered that certain aspects of the changes
made by the CPSC to its protocol were worthy of incorporation into ISO 8317:1989, principally to adopt the
older age range of adults forming the test panel and the method of the test.
ISO/TC 122/SC 3/WG 3 do not see these changes invalidating the classification of packages certified as child-
resistant under the previous International Standard for the child panel test, but, as the main purpose of the
adult test was to prove that adults could resecure the closure properly, the revised adult test protocol will
require repeating to reaffirm full child-resistant status of the package.
During the review, the opportunity was taken to incorporate Annexes A, B and C, together with the
amendment, into the main body of the document.

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SIST EN ISO 8317:2005
INTERNATIONAL STANDARD ISO 8317:2003(E)

Child-resistant packaging — Requirements and testing
procedures for reclosable packages
1 Scope
This International Standard specifies the requirements and test methods for reclosable packages designated
as resistant to opening by children.
Acceptance criteria are given for the package when tested by specified methods. These methods not only
provide a measure of the effectiveness of the package in restricting access by children, but also cover the
accessibility to the contents by adults.
Reclosable packages for any product intended to be exposed or removed from the packaging in normal use
are covered by the procedures.
This International Standard is intended for type approval only (see 3.1) 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 package
package consisting of a container and appropriate closure which is difficult for young children under the age of
fifty-two months to open (or gain access to the contents), but which is not difficult for adults to use properly
when tested and approved in accordance with the requirements of this International Standard
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 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. Liquid substitute product is always uncoloured water.
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SIST EN ISO 8317:2005
ISO 8317:2003(E)
3 General
3.1 Compliance with this International Standard
A child-resistant package tested in accordance with the requirements of this International Standard is shown
to be capable, when correctly made and used, of providing a satisfactory degree of resistance to opening by
children while maintaining accessibility to its contents by adults; in other words, the test is designed for type
approval. Manufacturers and fillers of child-resistant packaging shall be required to identify the attributes of
the packaging which confer resistance to opening by children of less than 52 months old and to devise and
institute tests as part of an implemented and documented quality control procedure to ensure that all
packages meet these child-resistance criteria. The type of testing required may be specific to the design of the
child-resistant package, but the test parameters of various classifications of the Coleman Research
Corporation (CRC) can be found in the American Society for Testing and Materials (ASTM) Standards Annual
Volume 15.09 [1], which can be used as a basis for developing an appropriate protocol.
The data compiled from mechanical test methods can be used to prove compliance of a package falling within
a “series of similar packaging”.
3.2 Packages for testing
Before child testing is carried out on reclosable child-resistant packages, both manufacturers and fillers shall
satisfy themselves that the life expectancy of the child-resistant package will exceed 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.
3.3 Test panels
Testing is carrie
...