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1、BRITISH STANDARD BS EN 862:2001 Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products The European Standard EN 862:2001 has the status of a British Standard ICS 55.020; 97.190 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PE
2、RMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 862:2001 This British Standard, having been prepared under the direction of the Consumer Products and Services Policy and Strategy Sector Committee, was published
3、 under the authority of the Standards Policy and Strategy Committee and comes into effect on 21 September 2001 BSI 21 September 2001 ISBN 0 580 37734 2 National foreword This British Standard is the official English language version of EN 862:2001. It supersedes BS EN 862:1997 which is withdrawn. Th
4、e UK participation in its preparation was entrusted by Technical Committee PKW/5, Primary and transport packaging, to Subcommittee PKW/5/27, Child-resistant packaging, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretar
5、y. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards El
6、ectronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to unde
7、rstand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cov
8、er, an inside front cover, the EN title page, pages 2 to 25 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+0
9、0:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 862 July 2001 ICS 55.020Supersedes EN 862:1997 English version Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products Emballages Emb
10、allage lpreuve des enfants Exigences et mthodes dessai pour emballages non refermables pour les produits non pharmaceutiques Verpackung Kindergesicherte Verpackung Anforderungen und Prfverfahren fr nichtwiederverschliebare Verpackungen fr nichtpharmazeutische Produkte This European Standard was appr
11、oved by CEN on 9 May 2001. 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 references concerning such national sta
12、ndards may be obtained on application to the 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 member into its own language and notified to
13、the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United
14、Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 862:2001 E Lic
15、ensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 862:2001 (E) 2 Contents Page Introduction 3 1Scope . 4 2Normative references . 5 3Terms and definitions. 5 4General. 5 4.1Compliance with the European Standard. 5 4.2Packages for testing. 6 5Re
16、quirements 6 5.1General safety requirements . 6 5.2Design requirements 6 5.3Acceptance requirements 6 5.4Child test 7 5.5Adult test (optional) 8 6Assessment of results 8 6.1Child test 8 6.2Adult test (optional) 9 6.3Overall result. 9 7Test report . 9 7.1General. 9 7.2Child test 10 7.3Adult test (opt
17、ional) 10 7.4Additional (option) information to be recorded. 10 7.5Overall test result 10 Annex A (normative) Tables for sequential test procedure.11 Annex B (normative) Charts for a sequential test procedure . 18 Annex C (informative) Non-closable child-resistant packaging Advice on providing openi
18、ng instructions. 22 Annex D (informative) Guidance for persons supervising tests with children. 23 Annex E (informative) Notes for guidance in adult testing . 24 Bibliography. 25 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 862:2001 (E
19、) 3 Foreword This European Standard has been prepared by 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 text or by endorsement, at the latest by Janu
20、ary 2002, and conflicting national standards shall be withdrawn at the latest by January 2002. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association This European Standard supersedes EN 862:1997. According to the CEN/
21、CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
22、 Switzerland and the United Kingdom. Introduction The use of potentially hazardous agents in certain products is necessary to achieve effectiveness. Consequently, steps are taken to limit the occurrence of accidents. One approach has been to try to increase general awareness of hazards associated wi
23、th various products; this approach has been used but public education aimed at protecting the child by educating the parents and other adults about correct storage practices, etc., has never been completely effective. Nevertheless, proper labelling and information by the manufacturer is important fo
24、r the safe use of products in the home. Another approach has been the use of child-resistant packaging to put a physical barrier between the child and the hazardous product. Such packaging could only be used for products as mentioned above since, if used in other circumstances, it could lead to conf
25、usion among consumers. It has to be recognized that it is unrealistic to expect that any functional packaging can be totally impossible for a child to open and this type of packaging cannot be a substitute for normal safety precautions. The packaging functions acts as a last defence if other barrier
26、s separating children and hazardous products have failed. This standard is designed to meet the requirements of the Directive 67/548/EEC as amended for the fourteenth time by Council Directive 91/410/EEC and complement the EN 28317 relating to child-resistant recloseable packages. There are now arou
27、nd the world various types of packagings which are recognized as child-resistant based on a test of the nature described. There is evidence that since these test methods were introduced the incidence of ingestion by children of hazardous products has fallen. The degree to which this is due to the us
28、e of child-resistant packaging against other factors, such as greater public awareness, is not easily assessed but there is little doubt that child-resistant packaging has made a positive contribution. Over the last decade much has been learned about the use of children for testing child-resistant p
29、ackaging and attention has been focused on how the number of children involved may be reduced. The development of European Standards incorporating mechanical test methods based on current European or national standards is appropriate to avoid unnecessary child panel testing and is essential in devel
30、oping physical package attributes usable by manufacturers. Because of the increasing use of child-resistant packaging, it is desirable to achieve European agreement on testing procedures in order to avoid confusion and misunderstanding in an area of great importance to the safety of young children.
31、A European Standard should also serve to reduce the number of children exposed to “training” during panel testing. However, it should not be supposed that the provision of a standard method for assessing child resistance is all that is needed either nationally or internationally. The test should be
32、administered by some responsible authority in each country adopting the European Standard, which should have confidence in the manner in which testing is carried out and thus common procedures should be adopted by all administering authorities covering such questions as: ? How is it decided that a c
33、hild-resistant packaging is needed? Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 862:2001 (E) 4 ? How is the test to be authorized and carried out? ? How and by whom will the results be evaluated and recorded? ? What minimum qualificat
34、ions are required of supervisors who carry out the procedure? ? How is it ensured that no child takes part in more than two tests and then only on packagings that are significantly different? ? How is it ensured that an identical package format is not tested more than once by different laboratories
35、other than for enforcement? Attention is drawn to the need to have adequate accreditation bodies. Evidence of conformity with this standard may be certified only by laboratories which conform with European Standards series EN 45000. This European Standard has been prepared to specify requirements an
36、d testing procedures for child- resistant packaging intended for potentially harmful products. It has been written as the best consensus which can be achieved at present and should be reviewed in 2 years and revised if necessary in the light of experience. NOTE 1This European Standard refers only to
37、 accessibility to the contents of the package. Attention is drawn to the need, when designing a child-resistant package, to give consideration to possible dangers linked to the risk of spillage which can happen unexpectedly when opening or trying to open the package. NOTE 2The on-going development o
38、f non-reclosable packaging offers a significant area for innovation in packaging. The styles of non-reclosable packages can be wide-ranging in design. Consequently, the development of mechanical test methods by manufacturers allied to current EN or national standards should be pursued as a means of
39、reducing the reliance on child panel testing. NOTE 3A fundamental change to the test period philosophy is applied because: ? there is a significant difference in the performance required from a non-reclosable packaging and; ? there is the difficulty in keeping the children motivated during a test pe
40、riod of 5 min. NOTE 4Mechanical 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 generating data by destructive or non destructive tests of a specific reference pack
41、age having shown child-resistant properties. A standard is in preparation to complement this EN 862. 1 Scope This European Standard specifies the requirements and test methods for non-reclosable child-resistant packages designated as resistant to opening by children. The standard applies to non-recl
42、osable packages of the “single-use” type of one or several individual units. Non-reclosable packages for pharmaceutical products are excluded. Acceptance criteria are given for the package when tested by specific methods. These methods do not only provide a measure of the effectiveness of the packag
43、e but also cover the accessibility to the contents by adults. This European Standard is intended for type approval only (see 4.1) and is not intended for quality assurance purposes. NOTEThe term “non-reclosable child-resistant package” covers not only packages where the seal is provided by a system
44、to prevent access by young children, designed for that purpose (for example, a package comprising separate compartments and including a supporting medium, pre-formed or not, which contains the product, along with a film Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 05:39:45 GMT+00:00 2006,
45、Uncontrolled Copy, (c) BSI EN 862:2001 (E) 5 material which constitutes the closure) but also those packages where there is no specific method of opening (for example, completely sealed sachets, etc.). 2 Normative references This European Standard incorporates, by dated or undated reference, provisi
46、ons from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by
47、amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). Not applicable. 3 Terms and definitions For the purposes of this standard, the following terms and definitions apply. 3.1 child-resistant package package which is difficult
48、 for young children to open (or gain access to the contents), but which is not difficult for adults to use properly in accordance with the requirements of this European Standard 3.2 non-reclosable child-resistant package child-resistant package or part of a child-resistant package from which the ent
49、ire content has to be removed at once and which cannot be properly closed again once opened, in a child-resistant form 3.3 substitute product inert substitute resembling the product it replaces, i.e. powder, tablets or liquids (uncoloured water), etc. 3.4 single use package package of one or several unit doses which are not only individually protected but are also individually packaged NOTEA blister is an example of a single-use package of the single-use type of one or several individual units. 3.5 unit dose discrete quantity of any product to be
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