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ISO 8362-5:2016

Injection containers and accessories — Part 5: Freeze drying closures for injection vials
15. 2. 2016.

Опште информације

90.93     9. 6. 2021.

ISO

ISO/TC 76

Međunarodni standard

11.040.20  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

ISO 8362-5:2016 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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 8362-5:2008

TRENUTNO

OBJAVLJEN
ISO 8362-5:2016
90.93 Odluka o potvrđivanju standarda
9. 6. 2021.

Nacionalna preuzimanja

SRPS EN ISO 8362-5:2017  
ISS

Injekcioni kontejneri i pomoćni pribor – Deo 5: Poklopci za liofiliziranje za injekcione bočice

60.60   Standard objavljen

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