Containers and accessories for pharmaceutical preparations — Part 5: Dropper assemblies
容器及附件药物制剂 - 第5部分:滴管组件
发布日期:
2015-02-27
ISO 11418-5:2015规定了滴管组件的设计、尺寸、材料和要求,滴管组件由螺帽、滴管球和移液管组成,用于液体药物制剂的应用和剂量。
ISO 11418的本部分适用于医疗领域中使用的滴管组件,以便根据ISO 11418-1交付螺旋颈瓶中包含的药物制剂。
滴管组件适用于与药物直接接触的初级包装。
注:药物在生产和储存期间的效力、纯度、稳定性和安全性可能会受到原包装的性质和性能的强烈影响。
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.