1、BRITISH STANDARDBS EN862:2005Packaging Child-resistant packaging Requirements and testing procedures for non-reclosablepackages for non-pharmaceuticalproductsThe European Standard EN 862:2005 has the status of a British StandardICS 55.020; 97.190g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3
2、g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIBS EN 862:2005This British Standard was published under the authority
3、 of the Standards Policy and Strategy Committee on 10 March 2006 BSI 10 March 2006ISBN 0 580 47909 9National forewordThis British Standard is the official English language version of EN 862:2005. It supersedes BS EN 862:2001 which is withdrawn.The UK participation in its preparation was entrusted by
4、 Technical Committee PKW/0, Packaging, to Subcommittee PKW/0/3, Child resistant packaging, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or Europea
5、n publications referred to in this document may be found in the BSI Catalogueunder the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all th
6、e necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on th
7、e interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 18, an inside back cover and a
8、back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 8
9、62November 2005ICS 55.020; 97.190 Supersedes EN 862:2001English VersionPackaging - Child-resistant packaging - Requirements andtesting procedures for non-reclosable packages for non-pharmaceutical productsEmballages - Emballage lpreuve des enfants -Exigences et mthodes dessai pour emballages nonrefe
10、rmables pour les produits non pharmaceutiquesVerpackung - Kindergesicherte Verpackung -Anforderungen und Prfverfahren frnichtwiederverschliebare Verpackungen frnichtpharmazeutische ProdukteThis European Standard was approved by CEN on 14 October 2005.CEN members are bound to comply with the CEN/CENE
11、LEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN
12、 member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN member
13、s are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United
14、Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 862:2005: ELicensed
15、 Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862:2005 (E) 2ContentsForeword.3Introduction 41 Scope52 Terms and definitions .53 Requirements.54 Testing65 Test report10Annex A (informative) Guidance for persons supervising tests with children.13Annex B (normative) Te
16、st charts .14Annex C (informative) Suitability of the sequential procedures chosen 17Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862:2005 (E) 3Foreword This document (EN 862:2005) has been prepared by Technical Committee CEN/TC 261 “Packaging” the secretar
17、iat of which is held by AFNOR. 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 May 2006, and conflicting national standards shall be withdrawn at the latest by May 2006. This document supersedes E
18、N 862:2001. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy
19、, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862:2005 (E) 4IntroductionChild-resistant packaging is used to cre
20、ate a physical barrier between a child and a potentially hazardous product. Various types of packaging are recognized 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 inciden
21、ce of accidental ingestion of potentially hazardous products by children under 5 years old has fallen. The degree to 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 dou
22、bt that this packaging has made a positive contribution to the reduction. The use of child-resistant packaging needs 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
23、over the degree of hazard posed by the product. In any case, proper labelling and information by the manufacturer is 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 fai
24、led. However, it has to be recognized that it is unrealistic to expect that 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. There has been an increasing use of
25、child-resistant packaging, therefore it is desirable to achieve agreement on testing procedures in order to avoid confusion and misunderstanding in an area of great importance to the safety of young children. This standard aims to reduce the number of children “exposed to training” during panel test
26、ing. Since the introduction of performance testing much has been learned about the use of children for testing 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
27、to avoid unnecessary child panel testing and is essential in developing physical package attributes useable 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 product
28、s out of the reach of children. The on-going development of non-reclosable packaging offers a significant 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
29、that the notified packaging is as safe as the original reference one. Mechanical tests are test methods generating 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 manufac
30、turers allied to current EN or national standards should be pursued as a means of reducing the reliance on child panel testing. Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862:2005 (E) 51 Scope This European Standard specifies performance requirements and
31、methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products. This standard is intended for type approval only (2.5) and is not intended for quality assurance purposes. This European Standard applies to non-reclosa
32、ble 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 standard. These are the subject of a separate standard, EN 14375 Child-resistant non-reclosable packaging for pharmaceutical product
33、s - Requirements and testing.2 Terms and definitions For the purposes of this European standard, the following terms and definitions apply. 2.1child-resistant package package which is difficult for young children to open (or gain access to the contents), but which it is possible for adults to use pr
34、operly 2.2non-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 closed again 2.3substitute product inert substitute resembling the product it replaces, i.e. powder, tablets or
35、liquids (uncoloured water), etc.2.4unitdiscrete quantity of any product to be removed from its immediate packaging in its entirety 2.5type approval procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified set of materials, which has met the requireme
36、nts of this 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 Requirements 3.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of this
37、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 according to the optional adult test (3.2.2). Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862
38、:2005 (E) 6A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified in this standard (3.2), shall be appropriate for the contents, provide mechanical protection and function properly for the life of the content and packaging. Manufacturers, compon
39、ent 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 with the requirements of this standard. NOTE EN ISO 9001 specifies requirements for quality management systems
40、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 shall be considered a failure in relation to a single use package if within 10 min, or 5 min when no demonstration has been g
41、iven, 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 child-resistant. 3.2.2 Adult test This test is optional unless a tool is supplied to open the container at the point of s
42、ale. 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, without a demonstration.NOTE To minimise the exposure of children to unnecessary testing the adult test should be carrie
43、d 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 up to 200 children aged 42 to 51 months is divided into pairs. Each child is given a number of non-reclosable packages
44、 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 further 5 min to open the package. The results are recorded sequentially, as obtained. The package is deemed child-resistan
45、t 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 % of the children are unable to access one or more units within the first 5 min. The packages accessibility may also b
46、e 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 instructions, and is allowed 5 min to familiarise themselves with the packaging. The number of adults opening the package with
47、in a 1 min test period is recorded. The package is deemed to comply with the requirements of this standard if at least 90 % of the adults are able to access at least 1 unit in 1 min. 4.2 Samples and sample preparation Sufficient packages shall be produced by the proposed manufacturing process to ena
48、ble 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 package to be tested; an Licensed Copy: Wang Bin, na, Mon May 15 06:46:22 BST 2006, Uncontrolled Copy, (c) BSIEN 862:2005 (E) 7ap
49、propriate 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, a new package shall be provided for each member of the test group. 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
