Obaly pro injekční přípravky a příslušenství - Část 5: Lyofilizované uzávěry pro injekční lahvičky (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.9.2016
Designation standards: ČSN EN ISO 8362-5
Classification mark: 703360
Catalog number: 500403
Publication date standards: 1.9.2016
The number of pages: 24
Approximate weight : 72 g (0.16 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
This part of 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. NOTE - The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging