ISO 11040-8:2016

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

Publication date: Nov 4, 2016

General information

Current stage: 90.92 Effective date: Oct 14, 2022

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.25

Languages: English French

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Status: 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

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