30.20 CD study/ballot initiated Oct 29, 2024
ISO
ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
International Standard
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.
PUBLISHED
ISO 11040-8:2016
IN_DEVELOPMENT
ISO/CD 11040-8
30.20
CD study/ballot initiated
Oct 29, 2024