SS-ISO-11040-8 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes (ISO 11040-8:2016, IDT)

SS-ISO-11040-8 - 2022 EDITION - CURRENT

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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.

To find similar documents by classification:

11.040.25 (Syringes, needles and catheters)

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Designation Name

SS-ISO 11040-8:2022

Revision Level




Publication Date

May 3, 2022



Page Count


International Equivalent

ISO 11040-8:2016(IDT)