ISO 11418-5:2015

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
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.120.99 - Other standards related to pharmaceutics
• 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: 9093 - International Standard confirmed
• Completion Date: 11-Jun-2020

Relations

• Revises: ISO 11418-5:1997 - Containers and accessories for pharmaceutical preparations — Part 5: Dropper assemblies
• Effective Date: 31-May-2014

Standards Content (Sample)

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
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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
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