Containers and accessories for pharmaceutical preparations — Part 5: Dropper assemblies

ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE 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.

Récipients et accessoires pour préparations pharmaceutiques — Partie 5: Compte-gouttes

General Information

Status
Published
Publication Date
26-Feb-2015
Current Stage
9093 - International Standard confirmed
Completion Date
11-Jun-2020
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ISO 11418-5:2015 - Containers and accessories for pharmaceutical preparations
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INTERNATIONAL ISO
STANDARD 11418-5
Second edition
2015-03-01
Containers and accessories for
pharmaceutical preparations —
Part 5:
Dropper assemblies
Récipients et accessoires pour préparations pharmaceutiques —
Partie 5: Compte-gouttes
Reference number
ISO 11418-5:2015(E)
©
ISO 2015

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ISO 11418-5:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

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ISO 11418-5:2015(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Dimensions and designation . 1
3.1 Dimensions . 1
3.1.1 Dropper bulb with small suction volume (DBS) . 3
3.1.2 Dropper bulb with medium suction volume (DBM) . 4
3.1.3 Screw cap. 5
3.1.4 Pipette . 6
3.2 Designation . 7
3.2.1 Screw cap. 7
3.2.2 Dropper bulb with small suction volume (DBS) . 7
3.2.3 Dropper bulb with medium suction volume (DBM) . 7
3.2.4 Pipette . 7
4 Material . 7
4.1 Dropper bulb . 7
4.2 Pipette. 8
4.3 Screw cap . 8
5 Requirements . 8
5.1 Dropper bulb . 8
5.2 Pipette. 8
Bibliography . 9
© ISO 2015 – All rights reserved iii

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ISO 11418-5:2015(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 wel
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