ISO - 8536-2
Infusion equipment for medical use — Part 2: Closures for infusion bottles
| Organization: | ISO |
| Publication Date: | 1 January 2023 |
| Status: | active |
| Page Count: | 20 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
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.
Document History