ISO 13926-2:2017

Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use

ISO 13926-2:2017 specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Systèmes de stylos-injecteurs — Partie 2: Bouchons-pistons pour stylos-injecteurs à usage médical

General Information

• Status: Published
• Publication Date: 27-Nov-2017
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 27-Apr-2023

Relations

• Revises: ISO 13926-2:2011 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
• Effective Date: 10-Dec-2016
• Revises: ISO 13926-2:2011/Amd 1:2015 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use — Amendment 1
• Effective Date: 10-Dec-2016

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13926-2
Third edition
2017-11
Pen systems —
Part 2:
Plunger stoppers for pen-injectors for
medical use
Systèmes de stylos-injecteurs —
Partie 2: Bouchons-pistons pour stylos-injecteurs à usage médical
Reference number
ISO 13926-2:2017(E)
©
ISO 2017

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ISO 13926-2:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved

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ISO 13926-2:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 1
5 Shape and dimensions . 2
6 Designation . 3
7 Material . 3
8 Requirements . 3
8.1 General . 3
8.2 Physical requirements . 3
8.2.1 Hardness . 3
8.2.2 Freedom from leakage . 3
8.2.3 Initiating and sustaining forces . 4
8.2.4 Resistance to ageing . 4
8.3 Chemical requirements. 4
8.4 Biological requirements . 4
9 Labelling . 4
Annex A (normative) Leakage test . 5
Bibliography . 7
© ISO 2017 – All rights reserved iii

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ISO 13926-2:2017(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. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (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 on 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 the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 13926-2:2011), which has been
technically revised. It also incorporates the Amendment ISO 13926-2:2011/Amd. 1:2015.
The main changes compared to the previous edition are as follows:
— the dimensions d , d and d in Table 1 have been changed from normative to informative; d is
1 2 3 2
required to align with ISO 13926-1;
— Formula (A.1) has been corrected.
A list of all parts in the ISO 13926 series can be found on the ISO website.
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ISO 13926-2:2017(E)

Introduction
Primary packaging components made of elastomeric materials are an integral part of medicinal
products and thus, the principles of current Good Manufacturing Practices (cGMP) apply to the
manufacturing of these components.
Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the
European Community and the United States of America.
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INTERNATIONAL STANDARD ISO 13926-2:2017(E)
Pen systems —
Part 2:
Plunger stoppers for pen-injectors for medical use
1 Scope
This document specifies the material, performance requirements and labelling and gives
recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage
can strongly be affected by the nature and performance of the primary packaging.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, onl
...