ISO 11418-5-1997 药剂容器及附件 第5部分:滴瓶组件

标准号：ISO 11418-5-1997
中文标准名称：药剂容器及附件 第5部分:滴瓶组件
英文标准名称：Containers and accessories for pharmaceutical preparations - Part 5: Dropper assemblies
标准类型：C47
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.120.99;55.100
适用范围：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.