Infusion equipment for medical use - Part 2: Closures for infusion bottles
STANDARD published on 1.8.2023
Designation standards: ČSN EN ISO 8536-2
Classification mark: 703350
Catalog number: 517230
Publication date standards: 1.8.2023
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
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