1、BS EN 862:2016Packaging Child-resistantpackaging Requirementsand testing procedures for non-reclosable packages for non-pharmaceutical productsBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 862:2016 BRITISH STANDARDNational forewordThis British Standard is the
2、 UK implementation of EN 862:2016. It supersedes BS EN 862:2005 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PKW/0/3, Child Resistant Packaging.A list of organizations represented on this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 publ
3、ication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 89662 0ICS 55.020; 97.190Compliance with a British Standard cannot confer immu
4、nity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 862:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 862 July 2016
5、ICS 55.020; 97.190 Supersedes EN 862:2005English Version Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products Emballages - Emballage lpreuve des enfants - Exigences et mthodes dessai pour emballages non refermables po
6、ur les produits non pharmaceutiques Verpackung - Kindergesicherte Verpackung - Anforderungen und Prfverfahren fr nichtwiederverschliebare Verpackungen fr nichtpharmazeutische Produkte This European Standard was approved by CEN on 27 May 2016. CEN members are bound to comply with the CEN/CENELEC Inte
7、rnal 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 references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any
8、 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 member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official ve
9、rsions. CEN members are the national 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
10、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploita
11、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 862:2016 EBS EN 862:2016EN 862:2016 (E) 2 Contents PageEuropean foreword . 3 Introduction 4 1 Scope 4 2 Terms and definitions . 5 3 Requirements . 5 4 Testing . 6 5 Test report 10 Annex A (informative) Guidanc
12、e for persons supervising tests with children . 13 Annex B (normative) Test charts . 14 Annex C (informative) Suitability of the sequential procedures chosen 17 Bibliography . 18 BS EN 862:2016EN 862:2016 (E) 3 European foreword This document (EN 862:2016) has been prepared by Technical Committee CE
13、N/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 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
14、 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 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. T
15、his document supersedes EN 862:2005. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugosl
16、av 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. BS EN 862:2016EN 862:2016 (E) 4 Introduction Child
17、-resistant packaging is used to create 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 pa
18、ckaging was introduced, the incidence 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 easil
19、y assessed, but there is little doubt 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 circu
20、mstances, there could be confusion 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 c
21、hild and hazardous product have failed. 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. T
22、here has been an increasing use of 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 European Standard aims to reduce the number of chil
23、dren “exposed to training” during panel testing. 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
24、based on mechanical test methods is required 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 the
25、ir duty to keep potentially dangerous products 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 generat
26、e test data for comparison and demonstration 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 deve
27、lopment of mechanical test methods by manufacturers allied to current EN or national standards should be pursued as a means of reducing the reliance on child panel testing. 1 Scope This European Standard specifies performance requirements and methods of test for non-reclosable packaging that has bee
28、n designated child-resistant and which is intended to contain non-pharmaceutical products. This European standard is intended for type approval only (2.5) and is not intended for quality assurance purposes. BS EN 862:2016EN 862:2016 (E) 5 This European Standard applies to non-reclosable packages of
29、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 are the subject of a separate standard, EN 14375, Child-resistant non-reclosable packaging for pharmaceutical products - Re
30、quirements 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 difficult for young children to open (or gain access to the contents), but which it is possible for adults to use properly 2.2 no
31、n-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 2.3 substitute product inert substitute resembling the product it replaces EXAMPLE Powder, tablets or liquids (
32、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-resistant a specific type of non-reclosable package, formed from a specified set of materials, which has met the requirements o
33、f 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 Requirements 3.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of t
34、his 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 according to the optional adult test (3.2.2). A non-reclosable child-resistant package, in addition to conforming to the per
35、formance 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 content and packaging. BS EN 862:2016EN 862:2016 (E) 6 Manufacturers, component manufacturers, fillers and packers of such p
36、ackages 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 European Standard. NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to demonstrate
37、 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 given, the child gains access to one or
38、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 sale. When tested in accordance with 4.3
39、.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. To minimize the exposure of children to unnecessary testing, the adult test should be carried out before the child test. 4 Testing 4.1
40、 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 to be opened by whatever means they wish
41、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-resistant if the trail of results on the test char
42、ts 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 be assessed by an optional full panel test
43、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 within a 1 min test period is recorded. The pa
44、ckage 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 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
45、 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 appropriate substitute product shall be used. The material and design of the test samples shall conform to the technical specification an
46、d 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. BS EN 862:2016EN 862:2016 (E) 7 Each sample package shall be checked for integrity before t
47、he 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 Comp
48、osition of child test group The test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with approximately equal numbers of girls and boys. As far as possible, there shall be an even distribution of ages and sexes within the panel. The children shall be selected at rando
49、m and shall have no apparent physical or mental disability that might affect manual dexterity. They shall not have taken part in more than one previous test and, in that test, a packaging of a different type and design shall have been used. If a child is used for more than one test, there shall be at least 4 weeks between tests. Parental or guardian consent shall be obtained before the child is used as a part of the test group. Any children having been involved in a reported poisoning accident shall be excluded from the test. Children should be selected to represent,
