ISO 13926-3:2019
(Main)Pen systems — Part 3: Seals for pen-injectors for medical use
Pen systems — Part 3: Seals for pen-injectors for medical use
This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
Systèmes de stylos-injecteurs — Partie 3: Joints pour stylos-injecteurs à usage médical
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INTERNATIONAL ISO
STANDARD 13926-3
Second edition
2019-05
Pen systems —
Part 3:
Seals for pen-injectors for medical use
Systèmes de stylos-injecteurs —
Partie 3: Joints pour stylos-injecteurs à usage médical
Reference number
©
ISO 2019
© ISO 2019
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 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 3
7 Material . 3
7.1 Cap . 3
7.2 Disc . 3
8 Requirements . 3
8.1 General . 3
8.2 Physical requirements . 3
8.2.1 Hardness of the disc . 3
8.2.2 Fragmentation . 4
8.2.3 Freedom from leakage . 4
8.2.4 Resealability . . 4
8.2.5 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
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 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.
This document 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 13926-3:2012), which has been
technically revised. The main changes compared to the previous edition are as follows:
— extension of the nature of cap in 7.1;
— deletion of one reference to a minimum requirement in 8.1;
— change of the reference in 8.2.2 to a needle for medical use;
— complete editorial revision.
A list of all parts in the ISO 13926 series can be found on the ISO website.
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.
iv © ISO 2019 – All rights reserved
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, for example, in ISO 15378.
INTERNATIONAL STANDARD ISO 13926-3:2019(E)
Pen systems —
Part 3:
Seals for pen-injectors for medical use
1 Scope
This document specifies the shape, dimensions, material, performance requirements and labelling of
seals for pen-injectors for medic
...
INTERNATIONAL ISO
STANDARD 13926-3
Second edition
2019-05
Pen systems —
Part 3:
Seals for pen-injectors for medical use
Systèmes de stylos-injecteurs —
Partie 3: Joints pour stylos-injecteurs à usage médical
Reference number
©
ISO 2019
© ISO 2019
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 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Shape and dimensions . 2
6 Designation . 3
7 Material . 3
7.1 Cap . 3
7.2 Disc . 3
8 Requirements . 3
8.1 General . 3
8.2 Physical requirements . 3
8.2.1 Hardness of the disc . 3
8.2.2 Fragmentation . 4
8.2.3 Freedom from leakage . 4
8.2.4 Resealability . . 4
8.2.5 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
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 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.
This document 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 13926-3:2012), which has been
technically revised. The main changes compared to the previous edition are as follows:
— extension of the nature of cap in 7.1;
— deletion of one reference to a minimum requirement in 8.1;
— change of the reference in 8.2.2 to a needle for medical use;
— complete editorial revision.
A list of all parts in the ISO 13926 series can be found on the ISO website.
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.
iv © ISO 2019 – All rights reserved
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, for example, in ISO 15378.
INTERNATIONAL STANDARD ISO 13926-3:2019(E)
Pen systems —
Part 3:
Seals for pen-injectors for medical use
1 Scope
This document specifies the shape, dimensions, material, performance requirements and labelling of
seals for pen-injectors for medic
...
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