Packaging — Tamper verification features for medicinal product packaging

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

Emballage — Témoins d'effraction pour emballages de médicaments

Le présent document définit les exigences et fournit des recommandations pour l'application, l'utilisation et le contrôle des témoins d'effraction sur les emballages de médicaments. Les principes du présent document peuvent être appliqués dans d'autres secteurs, selon le cas.

General Information

Status

Published

Publication Date

22-Nov-2018

ICS

11.120.99 - Other standards related to pharmaceutics

55.020 - Packaging and distribution of goods in general

Technical Committee

ISO/TC 122 - Packaging

Drafting Committee

ISO/TC 122 - Packaging

Current Stage

9060 - Close of review

Start Date

04-Jun-2029

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ISO 21976:2018 - Packaging -- Tamper verification features for medicinal product packaging

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INTERNATIONAL ISO
STANDARD 21976
First edition
2018-11
Packaging — Tamper verification
features for medicinal product
packaging
Emballage — Témoins d'effraction pour emballages de médicaments
Reference number
ISO 21976:2018(E)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 21976:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© 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

---------------------- Page: 2 ----------------------
ISO 21976:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Tamper verification features . 2
4.2 Purpose of tamper verification features . 2
4.3 Application and use of tamper verification features . 2
4.4 Check of tamper verification features . 3
5 Categories of tamper verification features . 3
5.1 General . 3
5.2 Folding boxes closed with glue . 3
5.2.1 Description . . . 3
5.2.2 Criteria of tamper verification . 3
5.2.3 Verification . 3
5.3 Specially constructed folding boxes . 4
5.3.1 Description . . . 4
5.3.2 Criteria of tamper verification . 5
5.3.3 Verification .
...

NORME ISO
INTERNATIONALE 21976
Première édition
2018-11
Emballage — Témoins d'effraction
pour emballages de médicaments
Packaging — Tamper verification features for medicinal product
packaging
Numéro de référence
ISO 21976:2018(F)
©
ISO 2018

---------------------- Page: 1 ----------------------
ISO 21976:2018(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2018
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2018 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 21976:2018(F)

Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Exigences générales . 2
4.1 Témoins d’effraction . . 2
4.2 Objectif des témoins d’effraction . 3
4.3 Application et utilisation des témoins d’effraction. 3
4.4 Contrôle des témoins d’effraction . 3
5 Catégories de témoins d’effraction . 3
5.1 Généralités . 3
5.2 Boîtes pliantes fermées avec de la colle . 4
5.2.1 Description . . . 4
5.2.2 Critères de vérification de l’effraction . 4
5.2.3 Vérification . 4
5.3 Boîtes pliantes de conception particulière . 5
5.3.1 Description . . . 5
5.3.2 Critères de vérification de l’effraction . 5
5.3.3 Vérification .
...

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