Објављен
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.
ПОВУЧЕН
ISO 8536-2:2010
ОБЈАВЉЕН
ISO 8536-2:2023
60.60
Стандард објављен
31. 1. 2023.
Опрема за инфузију за медицинску употребу – Део 2: Затварачи за боце за инфузију
60.60 Стандард објављен