SIST EN 14375:2004
(Main)Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.
Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte - Anforderungen und Prüfungen
Diese Europäische Norm legt Leistungsanforderungen und Prüfverfahren für nichtwiederverschließbare Verpackungen fest, die als kindergesichert bezeichnet werden. Diese Norm dient lediglich der Typprüfung (siehe 3.5) und nicht der Qualitätssicherung.
Emballage a l'epreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais
La présente norme fixe des criteres permettant d'établir que les emballages non refermables pour produits pharmaceutiques peuvent etre jugés a l'épreuve des enfants. L'emballage a l'épreuve des enfants n'est que le dernier élément d'une série de mesures de protection et ne dégage nullement les parents ou tuteurs de leur obligation de conserver les médicaments hors de portée des enfants. La présente Norme européenne est uniquement destinée a l'approbation de type (voir en 3.6) et non a l'assurance de la qualité.
Embalaža za farmacevtske proizvode, ki se ne zapira ponovno in je varna za otroke - Zahteve in preskusni postopki
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Embalaža za farmacevtske proizvode, ki se ne zapira ponovno in je
varna za otroke - Zahteve in preskusni postopkiKindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte - Anforderungen und PrüfungenEmballage a l'epreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essaisChild-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing97.190Otroška opremaEquipment for children55.020Pakiranje in distribucija blaga na splošnoPackaging and distribution of goods in general11.120.01Farmacija na splošnoPharmaceutics in generalICS:Ta slovenski standard je istoveten z:EN 14375:2003SIST EN 14375:2004en01-januar-2004SIST EN 14375:2004SLOVENSKI
STANDARD
SIST EN 14375:2004
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14375November 2003ICS 11.120.01; 55.020; 97.190English versionChild-resistant non-reclosable packaging for pharmaceuticalproducts - Requirements and testingEmballage à l'epreuve des enfants, non refermables pourproduits pharmaceutiques - Exigences et essaisKindergesicherte, nichtwiederverschließbare Verpackungenfür pharmazeutische Produkte - Anforderungen undPrüfungenThis European Standard was approved by CEN on 1 September 2003.CEN members are bound to comply with the CEN/CENELEC 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 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14375:2003 ESIST EN 14375:2004
EN 14375:2003 (E)2Contents
pageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54Requirements.55Testing.66Test report.10Annex A (informative)
Guidance for persons supervising tests with children.12Annex B (normative)
Test charts.13Annex C (informative)
Suitability of the sequential procedures chosen.16Bibliography.17SIST EN 14375:2004
EN 14375:2003 (E)3ForewordThis document (EN 14375:2003) has been prepared by Technical Committee CEN /TC 261, "Packaging", thesecretariat 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 orby endorsement, at the latest by May 2004, and conflicting national standards shall be withdrawn at the latest byMay 2004.Annexes A and C are informative.Annex B is normative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,Slovakia, Spain, Sweden, Switzerland and the United Kingdom.SIST EN 14375:2004
EN 14375:2003 (E)4IntroductionChild-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 againststandards for specific product categories and packaging types.Since child-resistant packaging was introduced, the incidence of accidental ingestion of potentially hazardousproducts by children under 5 years old has fallen. The degree to which this is due to the use of child-resistantpackaging 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 reduction.The use of child-resistant packaging needs to be confined to those products that are potentially hazardous, or forwhich any legislation makes its use mandatory, since, if used in other circumstances, there could be confusion overthe 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 thehome.Child-resistant packaging acts as the last line of defence if other barriers separating the child and hazardousproduct have failed. However, it should be recognized that it is unrealistic to expect that any functional packagingcan be totally impossible for a child of 42 to 51 months inclusive to open and that child-resistant packaging cannotbe a substitute for other safety precautions.There has been an increasing use of child-resistant packaging, therefore it is desirable to achieve agreement ontesting procedures in order to avoid confusion and misunderstanding in an area of great importance to the safety ofyoung children.The on-going development of non-reclosable packaging offers a significant area for innovation in packaging. Thestyles of non-reclosable packages can be wide-ranging in design.This standard aims to minimize the number of children “exposed to training” during panel testing. Since theintroduction of performance testing much has been learned about the use of children for testing child-resistantpackaging and attention has been focused on how the number of children involved can be reduced. Futuredevelopment of standards based on mechanical test methods is needed to avoid unnecessary child panel testingand 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 orguardians from their duty to keep medicinal products out of the reach of children.SIST EN 14375:2004
EN 14375:2003 (E)51 ScopeThis European Standard specifies performance requirements and methods of test for non-reclosable packagingthat have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is notintended for quality assurance purposes.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 862:2001Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosablepackages for non-pharmaceutical products.3 Terms and definitionsFor the purposes of this European Standard, the terms and definitions given in EN 862:2001 and the followingapply. 3.1 child-resistant packagepackage which is difficult for young children to open (or gain access to the contents), but which it is possible foradults to use properly3.2 non-reclosable child-resistant packagechild-resistant package or part of a child-resistant package which, when all or part of the contents have beenremoved, cannot be properly closed again3.3 substitute productinert substitute resembling the product it replaces, i.e. powder, tablets or liquids (uncoloured water), etc.NOTEThis is sometimes referred to as a placebo product.3.4 unit dose discrete quantity of any product to be removed from its immediate packaging in its entirety3.5type approval procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified set ofmaterials, which has met the requirements of this standard4 Requirements4.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of this standard, shallbe capable of providing a satisfactory degree of resistance to opening by children (see 4.2.1) and a satisfactorylevel of accessibility to its contents by adults (see 4.2.2).SIST EN 14375:2004
EN 14375:2003 (E)6 A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified inthis standard (see 4.2), shall be appropriate for the contents, provide mechanical protection and function properlyfor the life of the content and packaging. Manufacturers, component manufacturers, fillers and packers of such packages shall initiate and operateprocedures to control the quality of packaging materials so that type approved packaging is in accordance with therequirements of this standard.NOTEEN ISO 9001 specifies requirements for quality management systems where organizations need to demonstratetheir capability of supplying conforming products to customers.4.2 Performance requirements4.2.1 Child testAn individual child test shall be considered a failure in relation to unit, strip or blister packages if within 10 min thechild accesses more than 8 unit doses from the packaging provided.When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1.3, the packaging shall be deemed tobe child-resistant.NOTEThe figure of eight units is based on existing national standards published by certain CEN members and does notaddress the issue of toxicity.
Some pharmaceutical products on the market can cause harm to children by the ingestion of fewerthan eight units.
However, reliable data on child toxicity exists for few pharmaceutical products.
A harmful dose can beestablished for some existing pharmaceutical products and a maximum safe dose can be established for all pharmaceuticalproducts by one means or another.
Such information is not currently available for all products and there is no central registerwhere this information could be held. In the absence of European legislation on this topic the drafters of this European Standardacknowledge these concerns and believe that research and collection of data should continue with a view to considering thesubstitution of a toxicity based pass/fail criterion for the child panel test in a later revision.4.2.2 Adult testWhen tested in accordance with 5.3.3.2, at least 90 % of the adults shall be able to access at least 1 unit dosewithin the 1 min test period, without a demonstration.NOTETo minimise the exposure of children to unnecessary testing the adult test should be carried out before the childtest.5 Testing5.1 PrincipleType approval for non-reclosable child-resistant packaging is obtained by a sequential test method or full panel testfor children and a full panel test for adults. A test group of up to 200 children aged 42 to 51 months is divided intopairs. 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 isgiven a further 5 min to open the package. The results are recorded sequentially, as obtained. The package isdeemed child-resistant if the trail of results on the test charts passes into the acceptance zone or if at least 80 % ofthe children are unable to access more than eight unit doses within 10 min and at least 85 % of the children areunable to access more than eight unit doses within the first 5 min. The package’s accessibility by a test group of100 adults is also assessed. Each adult is given a non-reclosable package, any associated opening tools andwritten instructions, and is allowed 5 min to familiarize themselves with the packaging. The number of adultsopening the package within a 1 min test period is recorded. The package is deemed to comply with therequirements of this standard if at least 90 % of the adults are able to access at least 1 unit dose in 1 min.SIST EN 14375:2004
EN 14375:2003 (E)75.2 Samples and sample preparationSufficient packages shall be produced by the proposed manufacturing process to enable a representative sampleto be selected by the supervisor for testing and to provide a reserve for reference purposes. Dangerous productsshall not be used to fill the package to be tested; an appropriate substitute product shall be used.
The material anddesign of the test samples shall conform to the technical specification and they shall be representative of anaverage 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 adulttests, 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 presentedto the children without the outer retail packaging, giving them access to the individual unit doses.5.3 Procedure5.3.1 GeneralThe 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 test5.3.2.1 Composition of child test groupThe test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with approximately equalnumbers of girls and boys. As far as possible, there shall be an even distribution of ages and sexes within thepanel. The children shall be selected at random and shall have no apparent physical or mental disability whichmight affect manual dexterity.
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