Applicable medical devices:
This standard section applies to both tubing-glass barrels (single-chamber design) for injection preparations and sterilized sub-assembled syringes, ready for filling, but excludes plastic barrels for injectables and the glass cylinders, plunger stoppers and seals for dental local anesthetic cartridges.
Components which might complete the sub-assembled syringe (such as plunger or rod) are not covered as part of this standard section. Also demonstrating conformity to ISO 11040-4 standard alone does not ensure that the glass syringes can be properly connected to connecting devices (needles for injection, intravenous line luer connections, needleless luer locks, adapters, and transfer units), therefore to demonstrate this aspect all glass syringes intended to deliver drug or biological products have to meet the luer lock design as per ISO 594-2:1998. When a glass syringe is used with an injector or another device, additional ISO standards may apply.
Other ISO 11040 Sections that apply:
- ISO 11040-1:2015 Glass cylinders for dental local anesthetic cartridges
- ISO 11040-2:2011 Plunger stoppers for dental local anesthetic cartridges
- ISO 11040-3:2025 Seals for dental local anesthetic cartridges
- ISO 11040-5:2012 Plunger stoppers for injectables
- ISO 11040-6:2019 Plastic barrels for injectables and sterilized subassembled syringes ready for filling
- ISO 11040-7:2024 Packaging systems for sterilized subassembled syringes ready for filling
- ISO 11040-8:2026 Requirements and test methods for finished prefilled syringes.
This standard section specifies materials, dimensions, quality, and performance requirements – along with the test methods to assess these elements.
Testing capabilities to ISO 11040-4 include:
- Ease of assembly
- Dimensions – syringe inner and outer diameter
- Functional testing of luer connection with reference fittings
- Hydrolytic resistance
- Annealing quality
- Lubrication of the inner surface
- Luer cone breakage resistance (Break Force)
- Barrel – lubrication gliding test force
- Staked Needle – dimensions, design, lubrication, and pull out/off force/removal
- Needles or syringes with Staked Needle – penetration force
- Closure system – liquid leakage resistance, luer lock adaptor (LLA) collar pull-out force, and LLA collar torque resistance
- Luer lock rigid tip cap unscrewing torque
- Needle Shield/tip Cap Removal or pull-off force
- Container closure integrity – dye solution tightness test
Custom Testing
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design any functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of ISO 11040-4:2015.
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