Containers and accessories for pharmaceutical preparations Part 5: Dropper assemblies

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

27-02-2015

Publisher

International Organization for Standardization

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.

DevelopmentNote	Supersedes ISO/DIS 11418-5. (03/2015)
DocumentType	Standard
Pages	9
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11418-5:1997

Standards	Relationship
IS/ISO 11418 : Part 5 : 2015	Identical
DIN ISO 11418-5:2016-08 (Draft)	Identical
BS ISO 11418-5:2015	Identical
DIN ISO 11418-5 E : 2017	Identical
NEN ISO 11418-5 : 2015	Identical
DIN ISO 11418-5:2017-02	Identical

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ISO 720:1985	Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification
ISO 11418-1:2016	Containers and accessories for pharmaceutical preparations — Part 1: Drop-dispensing glass bottles
ISO 719:1985	Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classification