Draft
International StandardISO/DIS 11040-8
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Reference number
ISO/DIS 11040-8
ISO/DIS 11040-8
Edition 2
© ISO 2025
Proyecto Norma internacional
ISO/DIS 11040-8
85862
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Reemplazará ISO 11040-8:2016
Resumen
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.
Ciclo de vida
-
Anteriormente
PublicadoISO 11040-8:2016
-
Ahora
