Overview
ISO 11040-8:2016 - Prefilled syringes, Part 8 - specifies requirements and test methods for finished prefilled syringes intended for single use. It applies to aseptically filled or terminally sterilized finished prefilled syringes based on ISO 11040‑4 (glass barrels) or ISO 11040‑6 (plastic barrels), together with ISO 11040‑5 (plunger stoppers). The standard focuses on quality, functional performance and safety of the marketed syringe as a complete container-closure and delivery system. Syringes that require additional user preparation before injection (e.g., emptied diluent syringes used for reconstitution) are excluded.
Key topics and technical requirements
- User requirements: definition of intended use (users, route, environment, point-of-use), risk management and application of usability engineering (IEC 62366).
- System characterization: identification of critical dimensions, components and materials (barrel, plunger stoppers, additional components) and description of syringe contents.
- Performance requirements and test methods:
- Break‑loose and extrusion forces
- Burst and break resistance
- Closure system forces and torques
- Connectivity with fluid-path connectors (e.g., Luer standards)
- Residual (dead) volume and deliverable volume
- Needle penetration and pull‑out forces
- Sharps injury protection (see ISO 23908)
- Leakage beyond the plunger and container closure integrity
- Markings and labelling
- Pharmaceutical requirements: drug‑container interaction, biological compatibility, particulate matter (visible/sub-visible), and sterility considerations.
- Documentation: essential records to support design, testing and regulatory submissions.
Practical applications - who uses this standard
ISO 11040-8:2016 is used by:
- Pharmaceutical and combination-product manufacturers who market finished prefilled syringes.
- Contract fillers and device suppliers responsible for terminal sterilization, assembly and final packaging.
- Quality assurance, regulatory affairs and R&D teams for product design verification, validation and dossier preparation.
- Test laboratories performing performance, mechanical and container‑closure integrity testing.
- Procurement and supplier qualification teams to set acceptance criteria for finished prefilled syringes.
Practical uses include establishing performance specifications, designing risk‑based test plans aligned with ISO 14971, validating usability for intended user populations, and supporting regulatory submissions for parenteral products.
Related standards
Relevant normative references include: ISO 11040-4, ISO 11040-5, ISO 11040-6, ISO 23908, ISO 80369 series, ISO 7886-1, IEC 62366. Manufacturers should also consider pharmacopeial and regional regulatory requirements (Ph. Eur., USP, JP) in conjunction with ISO 11040‑8.
Open preview (PDF)Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes