EN ISO 14375:2023
(Main)Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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 has been approved by CEN as EN ISO 14375:2023 without any modification.
INTERNATIONAL ISO
STANDARD 14375
First edition
2018-07
Child-resistant non-reclosable
packaging for pharmaceutical
products — Requirements and testing
Emballages à l'épreuve des enfants, non refermables pour produits
pharmaceutiques — Exigences et essais
Reference number
ISO 14375:2018(E)
©
ISO 2018
ISO 14375:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 14375:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General requirements . 2
4.2 Performance requirements . 2
4.2.1 Child test . 2
4.2.2 Adult test. 2
5 Testing . 2
5.1 Principle . 2
5.2 Samples and sample preparation . 3
5.3 Procedure . 3
5.3.1 General. 3
5.3.2 Child test . 3
5.3.3 Adult test. 4
5.4 Evaluation . 5
5.4.1 Child test . 5
5.4.2 Adult test. 6
5.5 Overall test result . 6
6 Test report . 7
6.1 General . 7
6.2 Child test . 7
6.3 Adult test . 7
6.4 Additional (optional) information to be recorded . 8
6.5 Overall test result . 8
Annex A (informative) Guidance for persons supervising tests with children .9
Annex B (normative) Test charts .11
Annex C (informative) Suitability of the sequential procedures chosen .13
Bibliography .14
ISO 14375:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
This document was prepared by the European Committee for Standardization (CEN) (as EN 14375) and
was
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.