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ISO 11040-8:2016

Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

Nov 4, 2016

General information

90.92     Oct 14, 2022

ISO

ISO/TC 76

International Standard

11.040.25  

English   French  

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Published

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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

PUBLISHED
ISO 11040-8:2016
90.92 Standard to be revised
Oct 14, 2022

REVISED BY

IN_DEVELOPMENT
ISO/DIS 11040-8

National adoptions

SSH ISO 11040-8:2016  
DPS

Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

60.60 Standard published

DPS/KT 205 more