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

ISO-11418-5 - 2ND EDITION - CURRENT
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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.

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11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

11.120.99 (Other standards related to pharmaceutics Including equipment for pharmaceutical industry)

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Document Number

ISO 11418-5:2015

Revision Level

2ND EDITION

Status

Current

Publication Date

Feb. 27, 2015

Committee Number

ISO/TC 76