SIST EN ISO 13127:2013

Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems (ISO 13127:2012)

This International Standard specifies test methods for mechanical testing of reclosable child resistant packaging. The data generated by these mechanical test methods are suitable for comparing child resistant characteristics of related reclosable packaging systems. This International Standard is not intended for routine quality assurance purposes.

Verpackung - Kindergesicherte Verpackung - Mechanische Prüfverfahren für wiederverschließbare kindergesicherte Verpackungssysteme (ISO 13127:2012)

Dieses Dokument legt Prüfpläne für mechanische Prüfungen von wiederverschließbaren kindergesicherten Verpackungen fest. Es ist dafür bestimmt, Daten zu einer bestehenden, nach ISO 8317 typgeprüften Packung als Referenzdaten zu erzeugen. Diese Daten können für den Nachweis der Gleichwertigkeit eines kindergesicherten
Packungssystems mit der entsprechenden typgeprüften Packung verwendet werden (z. B. bei Änderung der Packungseigenschaften entweder durch Material oder Abmessung) und helfen, Zielgruppenprüfungen zu reduzieren. Die vorliegende Internationale Norm ist nicht für Zwecke der Qualitätssicherung und Qualitätskontrolle
gedacht. ANMERKUNG Der Einsatz von Kindern und Erwachsenen für Prüfungen nach ISO 8317 ist ein wesentliches Merkmal
dieser Norm.

Emballages - Emballages à l'épreuve des enfants - Méthodes d'essais mécaniques pour systèmes d'emballage refermables à l'épreuve des enfants (ISO 13127:2012)

L'ISO 13127:2012 spécifie les méthodes d'essais mécaniques pour les emballages refermables à l'épreuve des enfants. Les données obtenues par le biais de ces méthodes d'essais mécaniques conviennent à la comparaison des caractéristiques de résistance à l'ouverture par des enfants des systèmes d'emballage refermables correspondants.

Embalaža - Embalaža, varna za otroke - Mehanske preskusne metode za embalažo, ki jo je mogoče večkrat zapreti in je varna za otroke (ISO 13127:2012)

Ta mednarodni standard določa preskusne metode za mehansko preskušanje embalaže, ki jo je mogoče večkrat zapreti in je varna za otroke. Podatki, pridobljeni s temi mehanskimi preskusnimi metodami, so primerni za primerjavo lastnosti, ki se nanašajo na varnost za otroke, pri podobni embalaži, ki jo je mogoče večkrat zapreti. Ta mednarodni standard ni namenjen za rutinsko zagotavljanje kakovosti.

General Information

• Status: Published
• Public Enquiry End Date: 19-Oct-2009
• Publication Date: 20-Jan-2013
• ICS: 55.020 - Packaging and distribution of goods in general
• ICS: 97.190 - Equipment for children
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Jan-2013
• Due Date: 11-Mar-2013
• Completion Date: 21-Jan-2013
• Ref Project: EN ISO 13127:2012 - Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems (ISO 13127:2012)

Relations

• Corrected By: SIST EN ISO 13127:2013/AC:2013 - Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems - Technical Corrigendum 1 (ISO 13127:2012/Cor 1:2012)
• Effective Date: 01-Feb-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13127:2013
01-februar-2013
(PEDODåD(PEDODåDYDUQD]DRWURNH0HKDQVNHSUHVNXVQHPHWRGH]DHPEDODåR
NLMRMHPRJRþHYHþNUDW]DSUHWLLQMHYDUQD]DRWURNH,62
Packaging - Child resistant packaging - Mechanical test methods for reclosable child
resistant packaging systems (ISO 13127:2012)
Verpackung - Kindergesicherte Verpackung - Mechanische Prüfverfahren für
wiederverschließbare kindergesicherte Verpackungssysteme (ISO 13127:2012)
Emballages - Emballages à l'épreuve des enfants - Méthodes d'essais mécaniques pour
systèmes d'emballage refermables à l'épreuve des enfants (ISO 13127:2012)
Ta slovenski standard je istoveten z: EN ISO 13127:2012
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 13127:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 13127:2013

---------------------- Page: 2 ----------------------

SIST EN ISO 13127:2013


EUROPEAN STANDARD
EN ISO 13127

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2012
ICS 55.020
English Version
Packaging - Child resistant packaging - Mechanical test
methods for reclosable child resistant packaging systems (ISO
13127:2012)
Emballages - Emballages à l'épreuve des enfants - Verpackung - Kindergesicherte Verpackung - Mechanische
Méthodes d'essais mécaniques pour systèmes d'emballage Prüfverfahren für wiederverschließbare kindergesicherte
refermables à l'épreuve des enfants (ISO 13127:2012) Verpackungssysteme (ISO 13127:2012)
This European Standard was approved by CEN on 30 September 2012.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13127:2012: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 13127:2013
EN ISO 13127:2012 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 13127:2013
EN ISO 13127:2012 (E)
Foreword
This document (EN ISO 13127:2012) has been prepared by Technical Committee CEN/TC 261 "Packaging",
the secretariat of which is held by AFNOR, in collaboration with Technical Committee ISO/TC 122
"Packaging".
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 April 2013, and conflicting national standards shall be withdrawn at the
latest by April 2013.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 13127:2013

---------------------- Page: 6 ----------------------

SIST EN ISO 13127:2013
INTERNATIONAL ISO
STANDARD 13127
First edition
2012-10-01
Packaging — Child resistant packaging —
Mechanical test methods for reclosable
child resistant packaging systems
Emballages — Emballages à l’épreuve des enfants — Méthodes
d’essais mécaniques pour systèmes d’emballage refermables à
l’épreuve des enfants
Reference number
ISO 13127:2012(E)
©
ISO 2012

---------------------- Page: 7 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

---------------------- Page: 8 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Rationale . 2
4.2 Reference data . 2
4.3 Package modifications . 2
4.4 Testing facilities . 4
4.5 Test methods . 5
4.6 Test method selection . 5
4.7 Component verification . 5
5 Samples . 5
5.1 Sample selection . 5
5.2 Sample preparation . 5
6 Testing . 5
6.1 Applicability of tests . 5
6.2 Specific tests . 6
6.3 Assessment of test results . 6
7 Test report . 6
7.1 General . 6
7.2 Test facility (name and address) . 6
7.3 Applicant (name and address) . 6
7.4 Report number . 7
7.5 Date . 7
7.6 Manufacturer . 7
7.7 Packaging description . 7
7.8 References . 7
7.9 Test description and results . 7
7.10 Signature . 7
Annex A (normative) Torque release test . 8
Annex B (normative) Squeeze test . 9
Annex C (normative) Non-squeeze torque test .10
Annex D (normative) Press down and turn engagement test . 11
Annex E (normative) Push and turn test .12
Annex F (normative) Reverse ratchet torque test.13
Annex G (normative) Disassembly test .14
Annex H (normative) Rotational torque test .17
Annex I (normative) Push-off force .18
Annex J (normative) Application force .19
Bibliography .20
© ISO 2012 – All rights reserved iii

---------------------- Page: 9 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(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 13127 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 261, Packaging, in collaboration with ISO Technical Committee ISO/TC 122, Packaging, Subcommittee
SC 3, Performance requirements and tests for means of packaging, packages and unit loads, in accordance
with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).
iv © ISO 2012 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(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 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 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. 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 is important to recognize 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 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.
The aim of this International Standard is to establish mechanical test methods to safeguard child resistance
properties of the packaging system.
According to ISO 8317, the panel test is intended for initial type approval but it does not sufficiently cover
change management.
NOTE Change management covers, but is not limited to, for example, change of supplier, packaging material,
component manufacturing site, material brand or scale up.
Those changes need to be assessed using risk management procedures. Mechanical test methods deliver
scientific data which introduce a more scientific means of ensuring compliance with the originally type tested
package. The test results are essential for an appropriate risk assessment.
The object of this International Standard is to permit the comparison, by mechanical testing, of the physical
parameters of the packaging system under test with those of the individual units tested for certification purposes. It
is the responsibility of the component manufacturer to provide access to test methods and test data to the customer.
© ISO 2012 – All rights reserved v

---------------------- Page: 11 ----------------------

SIST EN ISO 13127:2013

---------------------- Page: 12 ----------------------

SIST EN ISO 13127:2013
INTERNATIONAL STANDARD ISO 13127:2012(E)
Packaging — Child resistant packaging — Mechanical test
methods for reclosable child resistant packaging systems
1 Scope
This International Standard specifies test methods for mechanical testing of reclosable child resistant packaging.
The data generated by these mechanical test methods are suitable for comparing child resistant characteristics
of related reclosable packaging systems.
This International Standard is not intended for routine quality assurance purposes.
NOTE The use of children and adults for testing in accordance with ISO 8317 is an essential feature of that standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 8317, Child-resistant packaging — Requirements and testing procedures for reclosable packages
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 8317 and the following apply.
3.1
mechanical testing
documented and reproducible test methods intended to measure the resistance of the relevant features of a
child resistant packaging system
3.2
essential characteristics
those elements of the container/closure system that are critical for maintaining the child resistant functionality
NOTE See 4.3 for examples of essential characteristics.
3.3
thread system
child resistant packaging system having a combination of container and closure that is reliant on having
compatible threads in order to maintain the child resistance functions and sealing integrity
3.4
squeeze and turn system
child resistant packaging system which requires the user to squeeze the closure at designated points while
simultaneously applying a torque to unscrew the closure from the container
3.5
push and turn system
press and turn system
child resistant packaging system which requires the user to apply a downward force while simultaneously
applying a torque to unscrew the closure from the container
© ISO 2012 – All rights reserved 1

---------------------- Page: 13 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
3.6
snap-cap system
align and lift system
child resistant packaging system which requires the user to align marks on the container and closure before
pushing off the closure
3.7
liner
medium used to form a seal between a closure and a container
3.8
original specification
full description of all components of the test specimens, including reference to number and issue of drawings,
dimensions, tolerances and material specification for all components
NOTE Components include, but are not limited to, closures, liners or containers.
3.9
reference data
data generated from type-approved child resistant packages using the testing methods specific to the packaging
type as given in this International Standard
NOTE Reference data provide the link between packages tested and found to be compliant with ISO 8317 and the
packages to be tested according to this International Standard.
4 General requirements
4.1 Rationale
This International Standard is intended to be used to generate mechanical test data from reclosable child
resistant packaging systems. These data may be used for the verification of equivalency of a child resistant
packaging system to a type-approved package (e.g. in the course of change management) and aims to avoid
unnecessary panel tests.
4.2 Reference data
Reference data shall be generated from type-approved packages using the testing methods specific to the
packaging type as given in Clause 6. Reference data should preferably be generated on the same package
lot(s) as used for type approval testing to ISO 8317. Where this is not possible, reference data may be generated
on an alternative lot, or lots, of the package, providing that the package lot is identical in design, construction
and specification to the type-approved package.
The identified test methods used to generate data from packages submitted for testing to ISO 8317, or from
packages fulfilling the specification, shall be used to set the test parameters for the range of packaging covered
by the original certification. Specifications with appropriate tolerances for the specific packaging shall be
defined when generating reference data.
4.3 Package modifications
ISO 8317 establishes that mechanical testing may be used to confirm the continued compliance of child
resistant packages, subject to minor changes to the package that was type-approved to ISO 8317.
NOTE Changes to a type-approved package that would result in the package being outside the criteria or dimensions of
a series of similar packages, require panel testing according to ISO 8317 to confirm compliance as a child resistant package.
The suitability and ability of mechanical testing to assess the impact of changes to a type-approved child
resistant package will vary according to the nature of the proposed changes. To decide upon this, for each
proposed change, a risk assessment shall be conducted to identify the potential impacts of the proposed
2 © ISO 2012 – All rights reserved

---------------------- Page: 14 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
change, and identify and assess the ability of the selected mechanical test methods to suitably measure those
impacts. The risk assessment and the rationale for the selected test methods shall be recorded.
Only where the impact of any change on child resistance performance can be reliably measured and quantified by
mechanical testing may mechanical testing alone be used to assess the continued compliance as a child resistant
package. In all other circumstances, child and adult panel testing according to ISO 8317 shall be conducted.
Changes affecting the essential characteristics shall be thoroughly evaluated in the course of the risk
assessment. The following elements are considered as essential characteristics of the container/closure
system and are important to maintain the child resistant functionality:
a) Container
— critical dimensions;
— material: glass, metal, different polymers, etc.;
— shape: round, square, rectangular, oval, etc.;
— handling: handle position, handle design, etc.;
— thread: form, position;
— neck: position, orientation, design, etc.;
— rigidity.
b) Closure
— critical dimensions;
— material: metal, different polymers, etc.;
— shape: round, square, rectangular, oval, etc.;
— handling: external gripping feature;
— thread: form, position;
— child resistant system: push down and turn, squeeze and turn, etc.;
— sealing feature: wad-liner, plug, etc.
The decision making process for the application of mechanical testing of minor changes to a type-approved
package is illustrated in Figure 1.
NOTE The mechanical test methods described in this International Standard are only capable of measuring
unidirectional (vertical and lateral) compression and tension forces, and rotational torque; they cannot measure or quantify
frictional or grip forces, for example, between a hand(s) and a package. Changes to a type-approved package that have
the potential to impact the hand grip of a child or adult on the package cannot therefore be assessed by methods described
in this International Standard.
© ISO 2012 – All rights reserved 3

---------------------- Page: 15 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
Risk assessment (NOTE 1)

Idenfy essenal characteriscs impacted by proposed change
& potenal effects of these on child resistant funconality

Can effects be
No
assessed by
mechanical tests

in 6.3?
Yes
Record the test raonale
conduct mechanical tesng
Data for all or most
tests fall outside of
the range of the
Reference Data or
Some, but not all test
No No
All test package data fall Specificaon
package data fall within

within the same range
and/or the
the same range as the
as the Reference deviaons show no
Reference Data
Data/Specificaon? consistent trend to
/Specificaon?
be all lower, or all

higher.
Yes

Yes

Test results are
Test results are higher
No
lower than
than Reference
Reference

Data/Specificaon?
Data/Specificaon?

Conduct Child Panel Test Conduct Adult Panel Test Conduct Full Panel
Approved
(NOTE 2) (NOTE 2) Test (N OTE 2)

Pass
Not Approved
Fail
NOTE 1 The use of suitable risk assessment methodology should be considered (e.g. IEC ISO 31010).
NOTE 2 Or reject modification.
Figure 1 — Decision flowchart for the use of mechanical testing of modifications
to a type-approved package
4.4 Testing facilities
Tests shall be carried out at a testing facility capable of meeting the operational provisions specified in
ISO/IEC 17025.
NOTE This does not imply a requirement for accreditation but, if appropriate, such external approval may be obtained
from either a national accreditation body or from the competent authority.
4 © ISO 2012 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 13127:2013
ISO 13127:2012(E)
4.5 Test methods
A number of mechanical test methods for different types of packaging systems are given in Annexes A to J.
Commercially available test equipment with appropriate jigs and fixtures for the packaging under test may be
used where appropriate.
4.6 Test method selection
Specific test methods, as given in 6.2, shall be chosen depending on the packaging type to be tested. Additional
test methods identified by the risk assessment can also be applied after validation. Their use and the rationale
for their use shall be recorded in the test report.
4.7 Component verification
It is the responsibility of the person(s) carrying out the mechanical test to ensure that the components match
the specification and that all functional parts of the system are present.
5 Samples
5.1 Sample selection
Child resistant packages submitted for mechanical testing shall be new and unfilled. Some safety features will
require the testing of individual components. Where the package depends for its child resistant properties on
the interaction between two or more components (e.g. lugs on the container engaging with features on the cap)
the system shall always be tested as a whole.
5.2 Sample preparation
A minimum of 10 samples per test shall be used.
Packages which incorporate an exterior and/or interior tamper-evident seal in addition to being child resistant
shall have the seal broken.
Containers and closures shall be assembled and closed according to their specification. Where torque is
required to apply the closure, the specified application torque shall be that recorded in the ISO 8317 test report
for the certified package.
A sample of the test package shall be opened and properly reclosed to check its functionality. This sample shall
then be discarded.
The assembled containers and closures shall be stored for 72 h at (23 ± 2)°C and (50 ± 5)% RH prior to
conducting tests. This is to allow materials (e.g. closure or liner) to take “a set”.
Testing shall be conducted immediately after conditioning of the packages.
NOTE It is recommended that assembly should not be carried out less than 24h after moulding to allow dimensional
stability to be achieved.
6 Testing
6.1 Applicability of tests
For generation of reference data, the child resistant package shall undergo the specific tests given in 6.2. For
modified packages, the system shall be tested according to the relevant tests in 6.2 as identified by the risk
assessment described in 4.3. Additional tests may be applied if required.
© ISO 2012 – All rights reserved 5

---------------------- Page: 17 ----------------------

SIST EN ISO 13127:2013
ISO 13127:20
...