Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges

ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only. NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499. It applies to primary packs used in direct contact with a drug. NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

Seringues préremplies — Partie 1: Tubes en verre pour cartouches dentaires d'anesthésie locale

General Information

Publication Date
Current Stage
9093 - International Standard confirmed
Completion Date
Ref Project


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ISO 11040-1:2015 - Prefilled syringes
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Standards Content (Sample)

STANDARD 11040-1
Second edition
Prefilled syringes —
Part 1:
Glass cylinders for dental local
anaesthetic cartridges
Seringues préremplies —
Partie 1: Tubes en verre pour cartouches dentaires d’anesthésie locale
Reference number
ISO 11040-1:2015(E)
ISO 2015

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ISO 11040-1:2015(E)

© ISO 2015, 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 2015 – All rights reserved

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ISO 11040-1:2015(E)

Contents Page
Foreword .iv
1 Scope .1
2 Normative references .1
3 Dimensions and designation .1
3.1 Dimensions . 1
3.2 Designation . 2
4 Requirements . 2
4.1 Material . 2
4.2 Performance . 2
5 Marking . 2
Bibliography .4
© ISO 2015 – All rights reserved iii

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ISO 11040-1:2015(E)

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
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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
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
Any trade name used in this document is information given for the convenience of users and does not
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assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is 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 11040-1:1992), which has been technically
revised with the following changes:
— including glass cylinders of 2,2 ml size;
— amending the requirements on performance and marking;
— editorial revision of this part of ISO 11040-1.
ISO 11040 consists of the following part

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