DIN EN ISO 13127-2013 Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems (ISO 13127 2012 + Cor 1 2012) German version .pdf

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1、March 2013 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、55.040!$#1“1970014www.din.deDDIN EN ISO 13127Packaging Child resistant packaging Mechanical test methods for reclosable child resistant packagingsystems (ISO 13127:2012 + Cor. 1:2012);English version EN ISO 13127:2012 + AC:2012,English translation of DIN EN ISO 13127:2013-03Verpackung Kindergesicher

3、te Verpackung Mechanische Prfverfahren fr wiederverschliebare kindergesicherteVerpackungssysteme (ISO 13127:2012 + Cor. 1:2012);Englische Fassung EN ISO 13127:2012 + AC:2012,Englische bersetzung von DIN EN ISO 13127:2013-03Emballages Emballages lpreuve des enfants Mthodes dessais mcaniques pour syst

4、mes demballage refermables lpreuve desenfants (ISO 13127:2012 + Cor. 1:2012);Version anglaise EN ISO 13127:2012 + AC:2012,Traduction anglaise de DIN EN ISO 13127:2013-03SupersedesDIN 55560-1:1988-07www.beuth.deDocument comprises 26 pagesIn case of doubt, the German-language original shall be conside

5、red authoritative.04.13 DIN EN ISO 13127:2013-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 13127:2012 + AC:2012) has been prepared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France) in collaboration with Technical Committee ISO/TC 122 “P

6、ackaging“. The responsible German body involved in its preparation was the Normenausschuss Verpackungswesen (Packaging Standards Committee), Working Committee NA 115-02-05 AA Kinder-gesicherte Verpackungen. The DIN Standards corresponding to the International Standards referred to in this document a

7、re as follows: ISO 8317 DIN EN ISO 8317 ISO 9001 DIN EN ISO 9001 ISO/IEC 31010 DIN EN 31010 (VDE 0050-1) ISO/IEC 17025 DIN EN ISO/IEC 17025 Amendments This standard differs from DIN 55560-1:1988-07 as follows: a) the content of DIN 55560-1:1988-07 has been incorporated in this standard (see Annex E)

8、; b) nine further test methods have been included (Annexes A to I); c) the terms and definitions are in accordance with ISO 8317; d) Clauses 4 “General requirements”, 5 “Samples”, 6 “Testing” and 7 “Test report” have been included for all test methods; e) the standard has been editorially revised. P

9、revious editions DIN 55560-1: 1988-07 National Annex NA (informative) Bibliography DIN EN ISO 8317, Child-resistant packaging Requirements and testing procedures for reclosable packages DIN EN ISO 9001, Quality management systems Requirements DIN EN 31010 (VDE 0050-1), Risk management Risk assessmen

10、t techniques DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13127 October 2012 + AC December 2012 ICS 55.020 English Version Packaging Child resistant packaging Mechanical test methods for

11、 reclosable child resistant packaging systems (ISO 13127:2012 + Cor 1:2012) Emballages Emballages lpreuve des enfants Mthodes dessais mcaniques pour systmes demballage refermables lpreuve des enfants (ISO 13127:2012 + Cor 1:2012) Verpackung Kindergesicherte Verpackung Mechanische Prfverfahren fr wie

12、derverschliebare kindergesicherte Verpackungssxsteme (ISO 13127:2012 + Cor 1:2012) EN ISO 13127:2012 was approved by CEN on 2012-09-30 and Corrigendum AC:2012 on 2012-12-01. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europ

13、ean 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

14、 (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, Bel

15、gium, 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, Switz

16、erland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. R

17、ef. No. EN ISO 13127:2012 + AC:2012 E Contents PageForeword .3Introduction 41 Scope 52 Normative references .53 Terms and definitions .54 General requirements .64.1 Rationale 64.2 Reference data .64.3 Package modifications .64.4 Testing facilities .84.5 Test methods 94.6 Test method selection 94.7 C

18、omponent verification .95 Samples .95.1 Sample selection .95.2 Sample preparation .96 Testing 96.1 Applicability of tests .96.2 Specific tests .6.3 Assessment of test results 7 Test report .107.1 General .107.2 Test facility (name and address) .107.3 Applicant (name and address) .107.4 Report number

19、 .117.5 Date .117.6 Manufacturer .117.7 Packaging description .117.8 References 117.9 Test description and results .117.10 Signature .11Annex A (normative) Torque release test .12Annex B (normative) Squeeze test 13Annex C (normative) Non-squeeze torque test 14Annex D (normative) Press down and turn

20、engagement test 15Annex E (normative) Push and turn test 16Annex F (normative) Reverse ratchet torque test17Annex G (normative) Disassembly test 18Annex H (normative) Rotational torque test 21Annex I (normative) Push-off force 22Annex J (normative) Application force .23Bibliography .2410102DIN EN IS

21、O 13127:2013-03 EN ISO 13127:2012 + AC:2012 (E) Foreword This document (EN ISO 13127:2012/AC:2012) 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

22、 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

23、 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,

24、 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, S

25、witzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13127:2012/Cor 1:2012 has been approved by CEN as EN ISO 13127:2012/AC:2012 without any modification. “”3DIN EN ISO 13127:2013-03 EN ISO 13127:2012 + AC:2012 (E) IntroductionA significant number of suspected cases of inges

26、tion 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 alk

27、aline 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

28、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. N

29、evertheless, 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 product

30、s 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 norm

31、al 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 metho

32、ds 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 materi

33、al, 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 ar

34、e 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

35、 the component manufacturer to provide access to test methods and test data to the customer.4DIN EN ISO 13127:2013-03 EN ISO 13127:2012 + AC:2012 (E) 1 ScopeThis International Standard specifies test methods for mechanical testing of reclosable child resistant packaging. The data generated by these

36、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 fe

37、ature of that standard.2 Normative referencesThe 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 8

38、317, Child-resistant packaging Requirements and testing procedures for reclosable packages3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 8317 and the following apply.3.1mechanical testingdocumented and reproducible test methods intended to measure th

39、e resistance of the relevant features of a child resistant packaging system3.2essential characteristicsthose elements of the container/closure system that are critical for maintaining the child resistant functionalityNOTE See 4.3 for examples of essential characteristics.3.3thread systemchild resist

40、ant 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 integrity3.4squeeze and turn systemchild resistant packaging system which requires the user to squeeze the closure at design

41、ated points while simultaneously applying a torque to unscrew the closure from the container3.5push and turn systempress and turn systemchild resistant packaging system which requires the user to apply a downward force while simultaneously applying a torque to unscrew the closure from the container5

42、DIN EN ISO 13127:2013-03 EN ISO 13127:2012 + AC:2012 (E) 3.6snap-cap systemalign and lift systemchild resistant packaging system which requires the user to align marks on the container and closure before pushing off the closure3.7linermedium used to form a seal between a closure and a container3.8or

43、iginal specificationfull description of all components of the test specimens, including reference to number and issue of drawings, dimensions, tolerances and material specification for all componentsNOTE Components include, but are not limited to, closures, liners or containers.3.9reference datadata

44、 generated from type-approved child resistant packages using the testing methods specific to the packaging type as given in this International StandardNOTE 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

45、International Standard.4 General requirements4.1 RationaleThis 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-

46、approved package (e.g. in the course of change management) and aims to avoid unnecessary panel tests.4.2 Reference dataReference 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 gene

47、rated 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 packa

48、ge.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 modificationsISO 8317 establishes that mechanical testing may be used to confirm the continued compliance of child res