STANDARD
ISO 11040-8:2016
Issue date: 2016 11 04
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
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.
General information on ISO 11040-8:2016
Timeline
An overview of the development of ISO 11040-8:2016 from 2016 til today.
-
ISO 11040-8:2026Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
-
ISO 11040-8:2016Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Frequently Asked Questions about ISO 11040-8:2016
When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.
Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.
If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.