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ISO 11040-8:2016

Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
4 nën 2016
95.99 Withdrawal of Standard   8 qer 2026

General information

95.99     8 qer 2026

ISO

ISO/TC 76

International Standard

11.040.25  

anglisht   frëngjisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

Scope

ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.

Life cycle

NOW

WITHDRAWN
ISO 11040-8:2016
95.99 Withdrawal of Standard
8 qer 2026

REVISED BY

PUBLISHED
ISO 11040-8:2026

National adoptions

SSH ISO 11040-8:2016  
DPS

Shiringa të mbushura paraprakisht - Pjesa 8: Kërkesat dhe metodat e provës për shiringat e mbushura paraprakisht të përfunduara

60.60 Standard published

DPS/KT 205 më tepër