Typical hypodermic needle tests which the Smithers Pira team perform include:
- Needle stiffness
- Needle resistance to breakage
- Patency of the lumen
- Freedom from defects
- Cleanliness inspections
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.
Method Development and Validation
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:
- Surface Finish
- Acidity and Alkalinity
- Size Designation
- Resistance to Breakage
- Resistance to Corrosion
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:
- Limits for Acidity and Alkalinity
- Limits for Extractable Metals
- Needle Hub - colour and connectivity
- Needle Tube
- Tolerances on Length
- Freedom from Defects
- Needle Point
- Needle bond strength
- Patency of lumen
- Sharps injury projection
- Needle penetration
Accreditation and Quality
Our laboratories are UKAS accredited to ISO 17025, and we can undertake activities with GMP compliance if required.
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