EN 14375:2016
(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 European 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 Prüfung
Diese Europäische Norm legt Leistungsanforderungen an und Prüfverfahren für nichtwiederverschließbare Verpackungen fest, die als kindergesichert bezeichnet werden. Diese Europäische Norm dient lediglich der Typprüfung (siehe 3.5) und nicht der Qualitätssicherung.
Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques - Exigences et essais
La présente Norme européenne spécifie les exigences de performances et les méthodes d’essai des emballages non refermables conçus pour être à l’épreuve des enfants. La présente Norme européenne est uniquement destinée à l’approbation de type (voir 3.5) et non à l’assurance de la qualité.
Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za otroke - Zahteve in preskusni postopki
Ta evropski standard določa zahteve glede učinkovitosti in preskusne metode za embalažo, ki je ni mogoče večkrat zapreti in je varna za otroke. Ta standard se uporablja samo za odobritev tipa (glej točko 3.5) in ne za namene zagotavljanja kakovosti.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische Produkte - Anforderungen und PrüfungenEmballages à l'épreuve 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 14375:2016SIST EN 14375:2017en,fr,de01-marec-2017SIST EN 14375:2017SLOVENSKI
STANDARDSIST EN 14375:2004/AC:2006SIST EN 14375:20041DGRPHãþD
SIST EN 14375:2017
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14375
July
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s v u y wã t r r uEnglish Version
Childæresistant nonæreclosable packaging for pharmaceutical products æ Requirements and testing Emballages à l 5ßpreuve des enfantsá non refermables pour produits pharmaceutiques æ Exigences et essais
Kindergesicherteá nichtwiederverschließbare Verpackungen für pharmazeutische Produkte æ Anforderungen und Prüfung This European Standard was approved by CEN on
t y May
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egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
9
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s v u y wã t r s x ESIST EN 14375:2017
EN 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 Annex C (informative)
Suitability of the sequential procedures chosen . 16 Bibliography . 17
SIST EN 14375:2017
EN 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 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
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