ISO 11418-5:2015

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

Standard Details

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.

General Information

Status : Published

Standard Type: Main

Document No: ISO 11418-5:2015

Document Year: 2015

Pages: 9

Edition: 2

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

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

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ISO 11418-5:2015

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ISO 11418-5:1997

ISO 11418-5:2015

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