1、BSI Standards PublicationBS EN ISO 8317:2015Child-resistant packaging Requirements and testingprocedures for reclosablepackagesBS EN ISO 8317:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 8317:2015.It supersedes BS EN ISO 8317:2004 which is withdrawn.
2、The UK participation in its preparation was entrusted to TechnicalCommittee PKW/0/3, Child Resistant Packaging.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. User
3、s are responsible for its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 79696 8ICS 55.020; 97.190Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority
4、of theStandards Policy and Strategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8317 December 2015 ICS 55.020 Supersedes EN ISO 8317:2004English Version Child-resistant packaging - Re
5、quirements and testing procedures for reclosable packages (ISO 8317:2015) Emballages lpreuve des enfants - Exigences et mthodes dessai pour emballages refermables (ISO 8317:2015) Kindergesicherte Verpackungen - Anforderungen und Prfverfahren fr wiederverschliebare Verpackungen (ISO 8317:2015) This E
6、uropean Standard was approved by CEN on 17 October 2015. 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 reference
7、s 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 mem
8、ber 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, Fr
9、ance, 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 COMIT EUROPEN DE NORMALISATION EUROPISCHES
10、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 reserved worldwide for CEN national Members. Ref. No. EN ISO 8317:2015 EBS EN ISO 8317:2015EN ISO 8317:2015 (E) 3 European foreword This document (EN I
11、SO 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 the status of a national standard, either by publication of an identical tex
12、t 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 subject of patent rights. CEN and/or CENELEC shall not be held responsible fo
13、r 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 this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
14、 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.
15、 Endorsement notice The text of ISO 8317:2015 has been approved by CEN as EN ISO 8317:2015 without any modification. BS EN ISO 8317:2015ISO 8317:2015(E)Foreword ivIntroduction vi1 Scope . 12 Terms and definitions . 13 Requirements 23.1 Test requirements 23.1.1 General 23.1.2 Evaluation of a series o
16、f similar packaging . 33.2 Test panels 43.3 Performance requirements 43.3.1 Requirements concerning children . 43.3.2 Requirements concerning adults . 44 Test procedures . 64.1 Test supervision . 64.2 Sample packages . 74.3 Preliminary checking and preparation 74.4 Child test . 74.4.1 Guidance for p
17、ersons supervising tests . 74.4.2 Composition of test group . 84.4.3 Test location . 84.4.4 Procedure . 84.4.5 Expression of results (see also 5.1) . 94.5 Adult test (50 years to 70 years old inclusive) 94.5.1 General 94.5.2 Composition of test group . 94.5.3 Procedure . 94.5.4 Expression of results
18、 (see also 5.2) 105 Assessment of results .105.1 Child test 105.1.1 Success/failure .105.1.2 Sequential method 105.1.3 Full test 115.2 Adult test . 115.3 Overall test result . 116 Test report 116.1 General 116.2 Child test 116.3 Adult test . 126.4 Additional (optional) information to be recorded 126
19、.5 Overall test result . 12Bibliography .13 ISO 2015 All rights reserved iiiContents PageBS EN ISO 8317:2015ISO 8317:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International
20、 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, a
21、lso take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1.
22、 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 ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the eleme
23、nts 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 the development of the document will be in the Introduction and/or on the ISO list of patent declarations received
24、 (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 of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adheren
25、ce 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, Packaging, Subcommittee SC 3, Performance requirements and tests for means of packaging, packages and unit loads (as
26、 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 8317:2003/Corr 1:2005.In addition to a number of editorial revisions, the following technical revisions have been made wit
27、h respect to the previous edition: introduction revised to remove historical discussion; definitions added for mechanical testing, mechanical test data, liner, essential characteristics, and minor modifications (2.6 to 2.10) former Clauses 3 and 4 consolidated into new Clause 3 and subsequent clause
28、s 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; introduction need to consider essential characteristics for a series of similar packaging (3.1.1); clarified instructions
29、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 minor modifications (3.1.2.5); reference made to ISO 13127 (Introduction and 3.1.2.5); charts for sequential testing
30、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 preparation of packages with torque dependent closures (4.3); deleted the limit (35 %) for the percentage of child tests adm
31、inistered by an individual tester (4.4.3);iv ISO 2015 All rights reservedBS EN ISO 8317:2015ISO 8317:2015(E) 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 individual tester (4.5.2). ISO 2015 All rights reserved
32、 vBS EN ISO 8317:2015ISO 8317:2015(E)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 effects involve products known
33、 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 (
34、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 occurrence of accidents. One ap
35、proach 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
36、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 that any functional packaging c
37、an 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 failed. Hence, the overall res
38、ponsibility 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 supervisory and accreditation bod
39、ies, 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 thata) appropriate quality s
40、ystems are in place to ensure that the child resistant packaging are correctlymanufactured and remain in compliance with this International Standard,b) the life expectancy of the child resistant packaging exceeds the maximum expected numberof openings and correct closings which are likely to occur i
41、n practice, without resulting inunacceptable impairment of the child resistant property or function, andc) the package meets the requirements of packaging, such as being appropriate for, and compatiblewith, the contents, providing mechanical protection and functioning properly for the life of thepac
42、kage in the intended geographical regions and climatic conditions.NOTE Certain products can affect the physical or mechanical properties of a packaging system which can lead to a loss of the child resistant function over time. In such a case, the packaging might not remain in compliance with this In
43、ternational Standard. Compatibility between the packaging and the contents needs to be assessed using appropriate methodology.ISO/TC 122/SC 3 do not see the changes made in this edition invalidating the classification of packages certified as child resistant under the previous edition of this Intern
44、ational Standard since the adult and child panel tests remain unchanged.vi ISO 2015 All rights reservedBS EN ISO 8317:2015INTERNATIONAL STANDARD ISO 8317:2015(E)Child-resistant packaging Requirements and testing procedures for reclosable packages1 ScopeThis International Standard specifies performan
45、ce requirements and test methods for reclosable packages designated as resistant to opening by children.Acceptance criteria are given for the packages when tested by specified methods. These methods not only provide a measure of the effectiveness of the packaging in restricting access by children, b
46、ut also cover the accessibility to the contents by adults.This International Standard is applicable to reclosable packages for any product intended to be exposed or removed from the packaging in normal use.This International Standard is intended for type approval only and is not intended for quality
47、 assurance purposes.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1containervessel 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 a
48、ttachment of a closure2.2closurecap or securing device of metal, plastic or a combination of materials designed to fit an appropriate container providing a secure seal against environmental challenges2.3child-resistant packagingpackage consisting of a container and appropriate closure which is diffi
49、cult for young children under the age of 52 months to open (or gain access to the contents), but which is not difficult for adults to use properly2.4reclosable packagepackage 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 security2.5substitute productinert substitute resembling the product it replacesNote 1 to entry: Solid substitute products for child-resistant packages normall
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