This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
WITHDRAWN
EN ISO 8536-2:2010
PUBLISHED
EN ISO 8536-2:2023
60.60
Standard published
Feb 15, 2023