1、BS EN 14375:2016Child-resistant non-reclosablepackaging for pharmaceuticalproducts Requirements andtestingBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 14375:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 14375:2016
2、 .It supersedes BS EN 14375:2003 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PKW/0/3, Child Resistant Packaging.A list of organizations represented on this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 publication does not purport to inc
3、lude 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 89661 3ICS 11.120.99; 55.020; 97.190Compliance with a British Standard cannot confer immunity fromlegal obli
4、gations.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 14375:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14375 July 2016 ICS 11.120.99;
5、55.020; 97.190 Supersedes EN 14375:2003English Version Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing Emballages lpreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais Kindergesicherte, nichtwiederverschliebare Verpac
6、kungen fr pharmazeutische Produkte - Anforderungen und Prfung This European Standard was approved by CEN on 27 May 2016. 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 withou
7、t 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 exists in three official versions (English, French, German). A version in any other la
8、nguage 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denm
9、ark, 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 andUnited Kingdom. EUROPEAN COMMITTEE
10、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 exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14375:2016 EBS EN 14375:2016EN
11、14375:2016 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 4 2 Normative references 4 3 Terms and definitions . 5 4 Requirements . 5 5 Testing . 6 6 Test report 10 Annex A (informative) Guidance for persons supervising tests with children . 12 Annex B (normative) Test charts . 13 An
12、nex C (informative) Suitability of the sequential procedures chosen 16 Bibliography . 17 BS EN 14375:2016EN 14375:2016 (E) 3 European foreword This document (EN 14375:2016) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the secretariat of which is held by AFNOR. This European Stand
13、ard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by 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 t
14、his document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14375:2003. Annexes A and C are informative. Annex B is normative. This document has been revised from EN 14375:2003 to correct Clause 5.4.1.
15、3.1. 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 Yugoslav Republic of Macedonia, France
16、, 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 14375:2016EN 14375:2016 (E) 4 Introduction Child-resistant packaging is used
17、 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 child-resistant packaging was introduced, t
18、he 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 easily assessed, but there is
19、little doubt that child-resistant 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, ther
20、e 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 child and hazar
21、dous product have failed. However, it should 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
22、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. The on-going development of non-reclosable packaging offers a signific
23、ant area for innovation in packaging. The styles of non-reclosable packages can be wide-ranging in design. This European Standard aims to minimize the number of children “exposed to training” during panel testing. Since the introduction of performance testing much has been learned about the use of c
24、hildren for testing child-resistant packaging and attention has been focused on how the number of children involved can be reduced. Future development of standards based on mechanical test methods is needed to avoid unnecessary child panel testing and is essential in developing physical package attr
25、ibutes 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 medicinal products out of the reach of children. 1 Scope This European Standard specifies performance requirements and met
26、hods of test for non-reclosable packaging that have been designated child-resistant. This European Standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes. 2 Normative references The following documents, in whole or in part, are normatively referenced
27、 in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Not applicable. BS EN 14375:2016EN 14375:2016 (E) 5 3 Terms and definitions For
28、 the purposes of this document, the following terms and definitions apply. 3.1 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 3.2 non-reclosable child-resistant package child-resistan
29、t package or part of a child-resistant package which, when all or part of the contents have been removed, cannot be properly closed again 3.3 substitute product inert substitute resembling the product it replaces Note 1 to entry: This is sometimes referred to as a placebo product. EXAMPLE Powder, ta
30、blets or liquids (uncoloured water), etc. 3.4 unit dose discrete quantity of any product to be removed from its immediate packaging in its entirety 3.5 type approval procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified set of materials, which has
31、 met the requirements of this European Standard 4 Requirements 4.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of this European Standard, shall be capable of providing a satisfactory degree of resistance to opening by children (see 4
32、.2.1) and a satisfactory level of accessibility to its contents by adults (see 4.2.2). A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified in this European Standard (see 4.2), shall be appropriate for the contents, provide mechanical protecti
33、on and function properly for the life of the content and packaging. Manufacturers, component 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
34、of this European Standard. NOTE EN ISO 9001 specifies requirements for quality management systems where organizations need to demonstrate their capability of supplying conforming products to customers. 4.2 Performance requirements 4.2.1 Child test An individual child test shall be considered a failu
35、re in relation to unit, strip or blister packages if within 10 min the child accesses more than 8 unit doses from the packaging provided. BS EN 14375:2016EN 14375:2016 (E) 6 When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1.3, the packaging shall be deemed to be child-resis
36、tant. NOTE The figure of eight units is based on existing national standards published by certain CEN members and does not address the issue of toxicity. Some pharmaceutical products on the market can cause harm to children by the ingestion of fewer than eight units. However, reliable data on child
37、toxicity exists for few pharmaceutical products. A harmful dose can be established for some existing pharmaceutical products and a maximum safe dose can be established for all pharmaceutical products by one means or another. Such information is not currently available for all products and there is n
38、o central register where this information could be held. In the absence of European legislation on this topic, the drafters of this European Standard acknowledge these concerns and believe that research and collection of data should continue with a view to considering the substitution of a toxicity
39、based pass/fail criterion for the child panel test in a later revision. 4.2.2 Adult test When tested in accordance with 5.3.3.2, at least 90 % of the adults shall be able to access at least 1 unit dose within the 1 min test period, without a demonstration. To minimize the exposure of children to unn
40、ecessary testing the adult test should be carried out before the child test. 5 Testing 5.1 Principle Type approval for non-reclosable child-resistant packaging is obtained by a sequential test method or full panel test for children and a full panel test for adults. A test group of up to 200 children
41、 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 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 t
42、he package. The results are recorded sequentially, as obtained. The package is deemed child-resistant 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 more than eight unit doses within 10 min and at least 85 % of the
43、children are unable to access more than eight unit doses within the first 5 min. The packages accessibility by a test group of 100 adults is also assessed. Each adult is given a non-reclosable package, any associated opening tools and written instructions, and is allowed 5 min to familiarize themsel
44、ves with the packaging. The number of adults opening the package within a 1 min test period is recorded. The package 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 dose in 1 min. 5.2 Samples and sample preparation
45、 Sufficient packages shall be produced by the proposed manufacturing process to enable 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 appropriate substitut
46、e 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 m
47、ember of the test group. For both the child and adult tests, there shall be at least 10 unit doses available for each participant. 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, givi
48、ng them access to the individual unit doses. BS EN 14375:2016EN 14375:2016 (E) 7 5.3 Procedure 5.3.1 General The test procedure is carried out in two stages: a) child test (see 5.3.2); b) adult test (see 5.3.3). 5.3.2 Child test 5.3.2.1 Composition of child test group The test group shall comprise n
49、o 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 random and shall have no apparent physical or mental disability which 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. Parenta
