DIN EN 862-2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products German version EN 862 2016《包.pdf

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1、September 2016 English price group 11No 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 55.020; 97.190!%0O“2561344www.

2、din.deDIN EN 862Packaging Childresistant packaging Requirements and testing procedures for nonreclosable packages for nonpharmaceutical products;English version EN 862:2016,English translation of DIN EN 862:2016-09Verpackung Kindergesicherte Verpackung Anforderungen und Prfverfahren fr nichtwiederve

3、rschliebare Verpackungen fr nichtpharmazeutische Produkte;Englische Fassung EN 862:2016,Englische bersetzung von DIN EN 862:2016-09Emballages Emballage lpreuve des enfants Exigences et mthodes dessai pour emballages non refermables pour les produits non pharmaceutiques;Version anglaise EN 862:2016,T

4、raduction anglaise de DIN EN 862:2016-09SupersedesDIN EN 862:200602www.beuth.deDocument comprises 20 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.08.16 DIN EN 862:2016-09 2 A comma is used as the decimal marker. National for

5、eword This document (EN 862:2016) has been prepared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Verpackungswesen (DIN Standards Committee Packaging), Working Committee NA 115-02-05 AA Kind

6、ergesicherte Verpackungen. Amendments This standard differs from DIN EN 862:2006-02 as follows: a) 4.4.1.3.1 and Annex C have been rendered more precise; b) the structure of the standard has been adapted to suit the current rules of presentation; c) the standard has been editorially revised. Previou

7、s editions DIN 55559: 1978-11, 1980-10, 1998-10 DIN EN 862: 1997-05, 2001-11, 2006-02 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 862 July 2016 ICS 55.020; 97.190 Supersedes EN 862:2005English Version Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclos

8、able packages for non-pharmaceutical products Emballages - Emballage lpreuve des enfants - Exigences et mthodes dessai pour emballages non refermables pour les produits non pharmaceutiques Verpackung - Kindergesicherte Verpackung - Anforderungen und Prfverfahren fr nichtwiederverschliebare Verpackun

9、gen fr nichtpharmazeutische Produkte This European Standard was approved by CEN on 27 May 2016. 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-d

10、ate 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 translatio

11、n 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, Fo

12、rmer 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 andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT

13、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 862:2016 EEN 862:2016 (E) 2 Contents Page European forew

14、ord . 3 Introduction 4 1 Scope 5 2 Terms and definitions . 5 3 Requirements . 5 4 Testing . 6 5 Test report 10 Annex A (informative) Guidance for persons supervising tests with children . 13 Annex B (normative) Test charts . 14 Annex C (informative) Suitability of the sequential procedures chosen 17

15、 Bibliography . 18 DIN EN 862:2016-09 EN 862:2016 (E) 3 European foreword This document (EN 862:2016) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the secretariat of which is held by AFNOR. The document has been revised from edition EN 862:2005 to correct Clause 4.4.1.3.1. This E

16、uropean 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 2017, and conflicting national standards shall be withdrawn at the latest by January 2017. Attention is drawn to the possibility that some of the

17、elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 862:2005. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are

18、 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, Por

19、tugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 862:2016-09 EN 862:2016 (E) 4 Introduction Child-resistant packaging is used to create a physical barrier between a child and a potentially hazardous product. Various types of packaging are recogniz

20、ed as being child-resistant, based on performance testing against standards for specific product categories and packaging types. Since this type of packaging was introduced, the incidence of accidental ingestion of potentially hazardous products by children under 5 years old has fallen. The degree t

21、o which this is due to the use of child-resistant packaging as opposed to other factors, such as greater public awareness of the hazards, is not easily assessed, but there is little doubt that this packaging has made a positive contribution to the reduction. The use of child-resistant packaging need

22、s to be confined to those products that are potentially hazardous, or for which any legislation makes its use mandatory, since, if used in other circumstances, there could be confusion over the degree of hazard posed by the product. In any case, proper labelling and information by the manufacturer i

23、s important for the safe use of the product in the home. Child-resistant packaging acts as the last line of defence if other barriers separating the child and hazardous product have failed. However, it has to be recognized that it is unrealistic to expect that any functional packaging can be totally

24、 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. There has been an increasing use of child-resistant packaging, therefore it is desirable to achieve agreement on testing procedures in order to avoid c

25、onfusion and misunderstanding in an area of great importance to the safety of young children. This European Standard aims to reduce the number of children “exposed to training” during panel testing. Since the introduction of performance testing, much has been learned about the use of children for te

26、sting child-resistant packaging and attention has been focused on how the number of children involved may be reduced. Future development of standards based on mechanical test methods is required to avoid unnecessary child panel testing and is essential in developing physical package attributes useab

27、le by manufacturers. Child-resistant packaging is only the last in a series of protective measures, and does not release parents or guardians from their duty to keep potentially dangerous products out of the reach of children. The on-going development of non-reclosable packaging offers a significant

28、 area for innovation in packaging. The styles of non-reclosable packages can be wide-ranging in design. 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 g

29、enerating data by destructive or non destructive tests of a specific reference package having shown child-resistant properties. 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 o

30、n child panel testing. DIN EN 862:2016-09 EN 862:2016 (E) 5 This European Standard applies to non-reclosable packages of the single-use type consisting of one or more individual units. Non-reclosable packages for pharmaceutical products are excluded from the scope of this European standard. These ar

31、e the subject of a separate standard, EN 14375, Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 child-resistant package package which is difficul

32、t for young children to open (or gain access to the contents), but which it is possible for adults to use properly 2.2 non-reclosable child-resistant package child-resistant package or part of a child-resistant package which, when all or part of the contents have been removed, cannot be properly clo

33、sed again 2.3 substitute product inert substitute resembling the product it replaces EXAMPLE Powder, tablets or liquids (uncoloured water), etc. 2.4 unit discrete quantity of any product to be removed from its immediate packaging in its entirety 2.5 type approval procedure to certify as child-resist

34、ant a specific type of non-reclosable package, formed from a specified set of materials, which has met the requirements of this European standard 2.6 single use package package of one or several units which are not only individually protected but also individually packed for single use 3 Requirement

35、s 3.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of this European Standard, shall be capable of providing a satisfactory degree of resistance to opening by children (3.2.1). Accessibility to its contents by adults can be checked acc

36、ording to the optional adult test (3.2.2). A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified in this European Standard (3.2), shall be appropriate for the contents, provide mechanical protection and function properly for the life of the con

37、tent and packaging. DIN EN 862:2016-09 1 Scope This European Standard specifies performance requirements and methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products. This European standard is intended for type

38、 approval only (2.5) and is not intended for quality assurance purposes. EN 862:2016 (E) 6 Manufacturers, component manufacturers, fillers and packers of such packages shall initiate and operate procedures to control the quality of packaging materials so that type approved packaging is in accordance

39、 with the requirements of this European Standard. NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to demonstrate their capability of supplying conforming products to customers. 3.2 Performance requirements 3.2.1 Child test An individual child test shal

40、l be considered a failure in relation to a single use package if within 10 min, or 5 min when no demonstration has been given, the child gains access to one or more units from the packaging provided. When tested in accordance with 4.3.2 and evaluated in accordance with 4.4.1, the packaging shall be

41、child-resistant. 3.2.2 Adult test This test is optional unless a tool is supplied to open the container at the point of sale. When tested in accordance with 4.3.3 and evaluated in accordance with 4.4.2, at least 90 % of the adults shall be able to access at least 1 unit within the 1 min test period,

42、 without a demonstration. To minimize the exposure of children to unnecessary testing, the adult test should be carried out before the child test. 4 Testing 4.1 Principle Type approval for non-reclosable child-resistant packaging is obtained by a sequential test method for children. A test group of

43、up to 200 children aged 42 to 51 months is divided into pairs. Each child is given a number of non-reclosable packages to be opened by whatever means they wish to use. If a child fails to gain access within 5 min, the method of opening is demonstrated by the supervisor and the child is given a furth

44、er 5 min to open the package. The results are recorded sequentially, as obtained. The package is deemed child-resistant if the trail of results on the test charts passes into the acceptance zone or if at least 80 % of the children are unable to access one or more units within 10 min and at least 85

45、% of the children are unable to access one or more units within the first 5 min. The packages accessibility may also be assessed by an optional full panel test for adults using a test group of 100 adults. Each adult is given a non-reclosable package, any associated opening tools and written instruct

46、ions, and is allowed 5 min to familiarise themselves with the packaging. The number of adults opening the package within a 1 min test period is recorded. The package is deemed to comply with the requirements of this European Standard if at least 90 % of the adults are able to access at least 1 unit

47、in 1 min. 4.2 Samples and sample preparation Sufficient packages shall be produced by the proposed manufacturing process to enable a representative sample to be selected by the supervisor for testing and to provide a reserve for reference purposes. Dangerous products shall not be used to fill the pa

48、ckage to be tested; an appropriate substitute product shall be used. The material and design of the test samples shall conform to the technical specification and they shall be representative of an average batch of original packages. Packages for the child panel test shall be unprinted. In every test

49、, a new package shall be provided for each member of the test group. DIN EN 862:2016-09 EN 862:2016 (E) 7 Each sample package shall be checked for integrity before the test is conducted. The packages shall be presented to the children without the outer retail packaging, giving them access to the individual units. 4.3 Procedure 4.3.1 General The test procedure is carried out in two stages: a) child test (4.3.2); b) adult test (4.3.3). 4.3.2 Child test 4.3.2.1 Composition of