ISO-11040-8 › Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes

ISO-11040-8 - 1ST 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.

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Document Number

ISO 11040-8:2016

Revision Level

1ST EDITION

Status

Current

Publication Date

Nov. 15, 2016

Committee Number

ISO/TC 76