ISO 13926-2:2011

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

ISO 13926-2:2011 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for pen-injectors for medical use.

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

General Information

• Status: Withdrawn
• Publication Date: 17-Mar-2011
• Withdrawal Date: 17-Mar-2011
• 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: 9599 - Withdrawal of International Standard
• Completion Date: 28-Nov-2017

Relations

• Revised: ISO 13926-2:2017 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
• Effective Date: 10-Dec-2016
• Amended By: ISO 13926-2:2011/Amd 1:2015 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use — Amendment 1
• Effective Date: 11-Dec-2021
• Revises: ISO 13926-2:1999 - Pen systems — Part 2: Plungers and discs for pen-injectors for medical use
• Effective Date: 06-Mar-2009

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13926-2
Second edition
2011-04-01

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 13926-2:2011(E)
©
ISO 2011

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ISO 13926-2:2011(E)


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©  ISO 2011
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ii © ISO 2011 – All rights reserved

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ISO 13926-2:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Classification .1
4 Shape and dimensions .2
5 Designation .3
6 Material .3
7 Requirements.3
8 Labelling.4
Annex A (normative) Leakage test.5
Bibliography.7

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ISO 13926-2:2011(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 13926-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 13926-2:1999), which has been technically
revised by
⎯ aligning this International Standard with the ISO 8871 series;
⎯ separating requirements on plunger stoppers (this part of ISO 13926) and seals; the latter are now
completely covered by ISO 13926-3;
⎯ revising Table 1 on dimensions of plunger stoppers;
⎯ revising the requirements on material, hardness, freedom from leakage, initiating and sustaining forces;
⎯ adding requirements on resistance to ageing.
ISO 13926 consists of the following parts, under the general title Pen systems:
⎯ Part 1: Glass cylinders for pen-injectors for medical use
⎯ Part 2: Plunger stoppers for pen-injectors for medical use
⎯ Part 3: Seals for pen-injectors for medical use
iv © ISO 2011 – All rights reserved

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ISO 13926-2:2011(E)
Introduction
Primary packaging components made of elastomeric materials are an integral part of medicinal products. As
such, the principles of current Good Manufacturing Practices (cGMP) are applicable to the manufacturing of
these components.
Principles of cGMP are described in ISO 15378 and in GMP Guidelines published by the European
[4] [5]
Community and the United States of America .

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INTERNATIONAL STANDARD ISO 13926-2:2011(E)

Pen systems —
Part 2:
Plunger stoppers for pen-injectors for medical use
1 Scope
This part of ISO 13926 specifies the shape, dimensions, material, performance requirements and labelling 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 be
affected significantly by the nature and performance of the primary packaging.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and
100 IRHD) [alternative normative reference to ISO 7619-1]
ISO 3302 (all parts), Rubber — Tolerances for products
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1:
Durometer method (Shore hardness) [alternative normative reference to ISO 48]
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables
in aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological
requirements and test methods
ISO 13926-1, Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
ISO 13926-3, Pen systems — Part 3: Seals for pen-injectors for medical use
3 Classification
Plunger stoppers shall be classified as follows:
⎯ Type A1: plunger stoppers with ribs;
⎯ Type A2: plunger stoppers without ribs;
⎯ Type A3: plunger stoppers with ribs and dome.
© ISO 2011 – All rights reserved 1

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