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 à l'epreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais

La présente norme fixe des critères permettant d'établir que les emballages non refermables pour produits pharmaceutiques peuvent être jugés à l'épreuve des enfants. L'emballage à 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 à l'approbation de type (voir en 3.6) et non à 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

Status
Withdrawn
Publication Date
18-Nov-2003
Withdrawal Date
12-Jul-2016
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
13-Jul-2016

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EN 14375:2004
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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/CENEL
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