1、September 2016 English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.120.99; 55.020; 97.190!%T-“
2、2564910www.din.deDIN EN 14375Childresistant nonreclosable packaging for pharmaceutical products Requirements and testing;English version EN 14375:2016,English translation of DIN EN 14375:2016-09Kindergesicherte, nichtwiederverschliebare Verpackungen fr pharmazeutische Produkte Anforderungen und Prfu
3、ng;Englische Fassung EN 14375:2016,Englische bersetzung von DIN EN 14375:2016-09Emballages lpreuve des enfants, non refermables pour produits pharmaceutiques Exigences et essais;Version anglaise EN 14375:2016,Traduction anglaise de DIN EN 14375:2016-09SupersedesDIN EN 14375:200402 andDIN EN 14375 Co
4、rrigendum 1:200604www.beuth.deDocument comprises 19 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.09.16 DIN EN 14375:2016-09 2 A comma is used as the decimal marker. National foreword This document (EN 14375:2016) has been pr
5、epared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Verpackungswesen (DIN Standards Committee Packaging), Working Committee NA 115-02-05 AA Kindergesicherte Verpackungen. Amendments This st
6、andard differs from DIN EN 14375:2004-02 and DIN EN 14375 Corrigendum 1:2006-04 as follows: a) Subclause 5.4.1.3.1 and Annex C have been rendered more precise; b) Figures B.1 and B.2 have been revised; c) the standard has been harmonized with the current rules of presentation; d) the standard has be
7、en editorially revised. Previous editions DIN 55559: 1978-11, 1980-10, 1998-10 DIN EN 14375: 2004-02 DIN EN 14375 Corrigendum 1: 2006-04 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14375 July 2016 ICS 11.120.99; 55.020; 97.190 Supersedes EN 14375:2003English Version Child-resistant non-recl
8、osable packaging for pharmaceutical products - Requirements and testing Emballages lpreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais Kindergesicherte, nichtwiederverschliebare Verpackungen fr pharmazeutische Produkte - Anforderungen und Prfung This European Sta
9、ndard 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 without any alteration. Up-to-date lists and bibliographical references concerning su
10、ch 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 member into its ow
11、n 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, France, Germany,
12、Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMU
13、NG 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 EEN 14375:2016 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 4 2 Normative refer
14、ences 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 Annex C (informative) Suitability of the sequential procedures chosen 16 Bibliography . 17 DIN EN
15、 14375:2016-09EN 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 Standard shall be given the status of a national standard, either by publication of an identical
16、 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 this document may be the subject of patent rights. CEN shall not be held responsible for ide
17、ntifying 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 5.4.1.3.1. According to the CEN-CENELEC Internal Regulations, the national standards organisation
18、s 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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
19、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 14375:2016-09EN 14375:2016 (E) 4 Introduction Child-resistant packaging is used to create a physical barrier between a child and a potentially hazardous product. Vari
20、ous 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, the incidence of accidental ingestion of potentially hazardous products by children unde
21、r 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 doubt that child-resistant packaging has made a positive contribution to the red
22、uction. 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 over the degree of hazard posed by the product. In any case, prope
23、r 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 failed. However, it should be recognized that it is unrealistic to ex
24、pect 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 child-resistant packaging, therefore it is desirable to achieve ag
25、reement 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 significant area for innovation in packaging. The styles of non-reclosable packages can be wide
26、-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 children for testing child-resistant packaging and attention has been focused on how the
27、 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 attributes useable by manufacturers. Child-resistant packaging is only the last in a series
28、 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 methods of test for non-reclosable packaging that have been designated child-resistant. Th
29、is 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 in this document and are indispensable for its application. For dated references, only
30、 the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Not applicable. DIN EN 14375:2016-09EN 14375:2016 (E) 5 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 chil
31、d-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-resistant package or part of a child-resistant package which, when all or part of the conte
32、nts 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, tablets or liquids (uncoloured water), etc. 3.4 unit dose discrete quantity of any pr
33、oduct 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 met the requirements of this European Standard 4 Requirements 4.1 General requirem
34、ents 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 4.2.1) and a satisfactory level of accessibility to its contents by adults (see 4.2.
35、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 protection and function properly for the life of the content and packaging. Manufacturers,
36、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 of this European Standard. NOTE EN ISO 9001 specifies requirements for quality mana
37、gement 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 failure in relation to unit, strip or blister packages if within 10 min the child access
38、es more than 8 unit doses from the packaging provided. DIN EN 14375:2016-09EN 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-resistant. NOTE The figure of eight units is based on existing national standards pu
39、blished 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 toxicity exists for few pharmaceutical products. A harmful dose can be establis
40、hed 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 no central register where this information could be held. In the absence of Euro
41、pean 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 based pass/fail criterion for the child panel test in a later revision. 4.2.2 A
42、dult 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 unnecessary testing the adult test should be carried out before the child test. 5
43、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 aged 42 to 51 months is divided into pairs. Each child is given a number of no
44、n-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 the package. The results are recorded sequentially, as obtained. The package is
45、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 children are unable to access more than eight unit doses within the first 5 min
46、. 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 themselves with the packaging. The number of adults opening the package within a 1 min
47、 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 Sufficient packages shall be produced by the proposed manufacturing process to
48、 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 substitute product shall be used. The material and design of the test samples shall conf
49、orm 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. 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 witho
