EN ISO 14375:2023

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document 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 (ISO 14375:2018)

Dieses Dokument legt Leistungsanforderungen an und Prüfverfahren für nichtwiederverschließbare Verpackungen fest, die als kindergesichert bezeichnet werden. Dieses Dokument dient lediglich der Typprüfung (siehe 3.5) und nicht der Qualitätssicherung.

Emballages non refermables à l’épreuve des enfants pour produits pharmaceutiques - Exigences et essais (ISO 14375:2018)

Le présent document spécifie les exigences de performances et les méthodes d’essai des emballages non refermables conçus pour être à l’épreuve des enfants. Le présent document est uniquement destiné 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 preskušanje (ISO 14375:2018)

Ta dokument določa zahteve glede učinkovitosti in preskusne metode za embalažo, ki je ni mogoče večkrat zapreti in je varna za otroke. Ta dokument se uporablja samo za odobritev tipa (glej točko 3.5) in ne za namene zagotavljanja kakovosti.
Vsebina dokumenta standarda EN 14375 ni bila spremenjena.

General Information

• Status: Published
• Publication Date: 28-Mar-2023
• ICS: 11.120.99 - Other standards related to pharmaceutics
• ICS: 55.020 - Packaging and distribution of goods in general
• ICS: 97.190 - Equipment for children
• Technical Committee: CEN/TC 261 - Packaging
• Drafting Committee: CEN/TC 261/SC 5/WG 27 - Child resistant packaging
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Mar-2023
• Due Date: 13-Jan-2025
• Completion Date: 29-Mar-2023
• Ref Project: SIST EN ISO 14375:2023 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)

Relations

• Replaces: EN 14375:2016 - Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
• Effective Date: 04-Oct-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14375:2023
01-maj-2023
Embalaža za farmacevtske proizvode, ki je ni mogoče večkrat zapreti in je varna za
otroke - Zahteve in preskušanje (ISO 14375:2018)
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements
and testing (ISO 14375:2018)
Kindergesicherte, nichtwiederverschließbare Verpackungen für pharmazeutische
Produkte - Anforderungen und Prüfungen (ISO 14375:2018)
Emballages à l'épreuve des enfants, non refermables pour produits pharmaceutiques -
Exigences et essais (ISO 14375:2018)
Ta slovenski standard je istoveten z: EN ISO 14375:2023
ICS:
11.120.01 Farmacija na splošno Pharmaceutics in general
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
97.190 Otroška oprema Equipment for children
SIST EN ISO 14375:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14375:2023

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SIST EN ISO 14375:2023


EN ISO 14375
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2023
EUROPÄISCHE NORM
ICS 55.020
English Version

Child-resistant non-reclosable packaging for
pharmaceutical products - Requirements and testing (ISO
14375:2018)
Emballages non refermables à l'épreuve des enfants Kindergesicherte, nichtwiederverschließbare
pour produits pharmaceutiques - Exigences et essais Verpackungen für pharmazeutische Produkte -
(ISO 14375:2018) Anforderungen und Prüfung (ISO 14375:2018)
This European Standard was approved by CEN on 17 March 2023.

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 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 language 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, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14375:2023 E
worldwide for CEN national Members.

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SIST EN ISO 14375:2023
EN ISO 14375:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 14375:2023
EN ISO 14375:2023 (E)
European foreword
The text of ISO 14375:2018 has been prepared by Technical Committee ISO/TC 122 "Packaging” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 14375:2023 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 September 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
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 identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14375:2018 h
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