DSF/PREN ISO 8536-2
Infusion equipment for medical use – Part 2: Closures for infusion bottles (ISO/DIS 8536-2:2022)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 20 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of ISO 8536 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 part of ISO 8536 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.
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