DSF/FPREN ISO 8362-5
Récipients et accessoires pour produits injectables - Partie 5: Bouchons à lyophilisation pour flacons d'injection (ISO/FDIS 8362-5:2015)
| Organization: | DS |
| Status: | pending |
| Page Count: | 18 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of EN ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8362 are intended for single use only.
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