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ISO 8362-5:2016

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

General information

90.93     9 qer 2021

ISO

ISO/TC 76

International Standard

11.040.20  

anglisht   frëngjisht  

Buying

Publikuar

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 8362-5:2008

NOW

PUBLISHED
ISO 8362-5:2016
90.93 Standard confirmed
9 qer 2021

National adoptions

SSH EN ISO 8362-5:2016  
DPS

Enë mbajtëse dhe pajisje ndihmëse për injeksionet - Pjesa 5: Mbyllje liofilitike për shishet e injeksionit (ISO 8362-5:2016)

60.60 Standard published

DPS/KT 205 më tepër