Manager of Medical Device Physical Testing
United KingdomContact Chris
Hypodermic needle tests we commonly perform include:
Should your component be defective or inefficient, our team are able to diagnose the root cause of the issue and suggest remedial actions to improve product performance. We are also able to provide wider product development support for medical devices, including an assessment of component compatibility, functionality and integrity testing.
For projects where standard testing procedures don’t fulfil client requirements, our experts can develop a bespoke test method to assess your required parameters.
Our validated test methods can be used to confirm that the design outputs meet the design input requirements.
There are two main ISO standards which are used for hypodermic needle testing – ISO 9626 and ISO 7864.
ISO 9626 applies to rigid stainless steel needle tubing, which is used in the manufacture of hypodermic needles (among other medical devices). The standard applies to steel tubing in metric sizes 3,4mm (10 Gauge) to 0,18mm (34 Gauge). This standard covers:
Additional testing may also be required once the tube has been incorporated into the whole device, to ensure that it still operates as anticipated and in a safe manner.
ISO 7864 applies to sterile hypodermic needles intended as a component in single use devices. The standard applies to needles in metric sizes 0,18mm to 1,2mm. Tests include:
Our laboratories are UKAS accredited to ISO 17025, and we can undertake activities with GMP compliance if required.