Prefilled syringes

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

General Information

Status
Published
Publication Date
18-Nov-2015
Current Stage
6060 - International Standard published
Start Date
29-Sep-2015
Completion Date
19-Nov-2015
Ref Project

RELATIONS

Effective Date
26-Jul-2014

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ISO 11040-1:2015 - Prefilled syringes
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INTERNATIONAL ISO
STANDARD 11040-1
Second edition
2015-12-01
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
---------------------- Page: 1 ----------------------
ISO 11040-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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
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copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
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)
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 meaning of ISO specific terms and expressions related to conformity

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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