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ISO 11418-5:2015

Containers and accessories for pharmaceutical preparations — Part 5: Dropper assemblies ISO 11418-5:2015

Publication date:   Feb 27, 2015

General information

90.93 Standard confirmed   Jun 11, 2020

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment | 11.120.99   Other standards related to pharmaceutics

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11418-5:1997

NOW

PUBLISHED
ISO 11418-5:2015
90.93 Standard confirmed
Jun 11, 2020