DIN EN ISO 8317-2016 Child-resistant packaging - Requirements and testing procedures for reclosable packages (ISO 8317 2015) German version EN ISO 8317 2015《防儿童拆开的包装 可再次包装件的要求和试验程序.pdf

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1、May 2016 English price group 13No 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!%SM“2484204www.din.deDIN EN I

2、SO 8317Child-resistant packaging Requirements and testing procedures for reclosable packages (ISO 8317:2015);English version EN ISO 8317:2015,English translation of DIN EN ISO 8317:2016-05Kindergesicherte Verpackungen Anforderungen und Prfverfahren fr wiederverschliebare Verpackungen (ISO 8317:2015)

3、;Englische Fassung EN ISO 8317:2015,Englische bersetzung von DIN EN ISO 8317:2016-05Emballages lpreuve des enfants Exigences et mthodes dessai pour emballages refermables (ISO 8317:2015);Version anglaise EN ISO 8317:2015,Traduction anglaise de DIN EN ISO 8317:2016-05SupersedesDIN EN ISO 8317:2004-11

4、 andDIN EN ISO 8317Corrigendum 1:2005-10www.beuth.deDocument comprises 22 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.16 DIN EN ISO 8317:2016-05 2 A comma is used as the decimal marker. National foreword This document (E

5、N ISO 8317:2015) has been prepared by Technical Committee ISO/TC 122 “Packaging” in collaboration with Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Verpackungswesen (DIN Standards Committee Pa

6、ckaging), Working Committee NA 115-02-05 AA Kindergesicherte Verpackungen. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 13127 DIN EN ISO 13127 ISO/IEC 17025 DIN EN ISO/IEC 17025 Amendments This standard differs from DIN EN ISO 8317:2

7、004-11 and DIN EN ISO 8317 Corrigendum 1:2005-10 as follows: a) the Introduction has been rendered more precise; b) Subclauses 2.6 to 2.11 with further terms and definitions have been added; c) the former Clauses 3 and 4 have been combined in a new Clause 3, and subsequent clauses have been renumber

8、ed; d) the requirements given in the previous edition in Subclauses 3.1, 3.2 and 4.2 have been moved to the Introduction; e) the instructions for the evaluation of a series of similar packaging submitted at the same time, separately per component type (3.1.2.2, 3.1.2.3, 3.1.2.4) have been rendered m

9、ore precise; f) a new Subclause 3.1.2.5 dealing with additions to a series and minor modifications has been added; g) the charts for sequential testing have been updated (Figures 1 and 2); h) for torque-dependant closure systems on packages to be tested, use of a torque meter for the preparation of

10、packages for testing has been specified (4.3); i) the limit (35 %) for the percentage of child tests administered by an individual tester has been deleted (4.4.3); j) the limit for the number of adults (30) obtained from or tested at any one site and the number of adult tests (35) administered by an

11、 individual tester have been deleted (4.5.2); k) the standard has been editorially revised. Previous editions DIN 55559: 1978-11, 1980-10 DIN EN 28317: 1993-02, 1994-03 DIN EN ISO 8317: 2004-11 DIN EN ISO 8317 Corrigendum 1: 2005-10 DIN EN ISO 8317:2016-05 3 National Annex NA (informative) Bibliogra

12、phy DIN EN ISO 13127, Packaging Child resistant packaging Mechanical test methods for reclosable child resistant packaging systems DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO 8317:2016-05 4 This page is intentionally blank EUROPEAN

13、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8317 December 2015 ICS 55.020 Supersedes EN ISO 8317:2004English Version Child-resistant packaging - Requirements and testing procedures for reclosable packages (ISO 8317:2015) Emballages lpreuve des enfants - Exigences et mthodes dessai pour emballag

14、es refermables(ISO 8317:2015) Kindergesicherte Verpackungen - Anforderungen und Prfverfahren fr wiederverschliebare Verpackungen (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 th

15、e 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

16、 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 nationa

17、l 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, Slovak

18、ia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means

19、reserved worldwide for CEN national Members. Ref. No. EN ISO 8317:2015 EEuropean foreword .3Introduction .51 Scope . 62 Terms and definitions . 63 Requirements 73.1 Test requirements 73.1.1 General 73.1.2 Evaluation of a series of similar packaging . 83.2 Test panels 93.3 Performance requirements 93

20、.3.1 Requirements concerning children . 93.3.2 Requirements concerning adults . 94 Test procedures 114.1 Test supervision 114.2 Sample packages 124.3 Preliminary checking and preparation . 124.4 Child test 124.4.1 Guidance for persons supervising tests 124.4.2 Composition of test group 134.4.3 Test

21、location 134.4.4 Procedure 134.4.5 Expression of results (see also 5.1) 144.5 Adult test (50 years to 70 years old inclusive) . 144.5.1 General. 144.5.2 Composition of test group 144.5.3 Procedure 144.5.4 Expression of results (see also 5.2) 155 Assessment of results .155.1 Child test 155.1.1 Succes

22、s/failure .155.1.2 Sequential method 155.1.3 Full test 165.2 Adult test . 165.3 Overall test result . 166 Test report 166.1 General 166.2 Child test 166.3 Adult test . 176.4 Additional (optional) information to be recorded 176.5 Overall test result . 17Bibliography .18Contents PageDIN EN ISO 8317:20

23、16-05 EN ISO 8317:2015 (E)2Foreword .4European 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 t

24、he 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 su

25、bject 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

26、 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, Slo

27、vakia, 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. DIN EN ISO 8317:2016-05 EN ISO 8317:2015 (E)3 ForewordISO (the International Organization for Standardizatio

28、n) 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 rep

29、resented 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 dev

30、elop 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 IS

31、O/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

32、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

33、 of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 122, Pa

34、ckaging, 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 8317:200

35、3/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,

36、 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; introduc

37、tion 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 min

38、or 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 preparatio

39、n 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); 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 individ

40、ual tester (4.5.2).DIN EN ISO 8317:2016-05 EN ISO 8317:2015 (E)4 IntroductionA 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 ef

41、fects 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.

42、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 occ

43、urrence 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

44、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 tha

45、t 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 fa

46、iled. 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, ISO 131271describes appropriate methodology that may be used.Attention is drawn to the need to have adequate super

47、visory and accreditation bodies, please see ISO/IEC 17025,2which 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

48、thata) 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 closin

49、gs which are likely to occur in practice, without resulting in unacceptable impairment of the child resistant property or function, andc) the package meets the requirements of packaging, such as being appropriate for, and compatible with, the contents, providing mechanical protection and functioning