ISO 11418-5:2015 PDF

Scope: This part of ISO 11418 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.

ISO 11418-5:2015 Referenced Document

ISO 11418-1:2005 Containers and accessories for pharmaceutical preparations - Part 1: Drop-dispensing glass bottles
ISO 4802-1:2010 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 1: Determination by titration method and classification
ISO 4802-2:2010 Glassware - Hydrolytic resistance of the interior surfaces of glass containers - Part 2: Determination by flame spectrometry and classification
ISO 719:1985 Glass; Hydrolytic resistance of glass grains at 98 degrees C; Method of test and classification
ISO 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification
ISO 8362-2:2008 Injection containers and accessories - Part 2: Closures for injection vials
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
ISO 8871-5:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing

2015 ISO 11418-5:2015 Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies
1997 ISO 11418-5:1997 Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies