Standard name: Sterile single-use syringes, with or without needle, for insulin.
Applicable medical devices:
This standard applies to sterile single use syringes with or without needles intended for immediate use after filling solely for the injection of insulin.
Testing capabilities to ISO 8537 include:
- Tolerance of nominal/graduated capacity
- Graduate scale – scale, numbering, positioning, overall length
- Barrel – dimensions and finger grips
- Piston design, function, length, detachment and fit in the syringe barrel
- Visual examination (clarity, colour, presence of particles)
- Performance – dead space determination, freedom from air and liquid leakage past piston, nozzle/hub or needle/barrel unions
- Plunger movement and pull out forces and flow characteristics.
- Lubricant – visibility and Quantity for syringes and needles
- Compatibility tests between syringes and injection fluids- Resistivity, Spectrophotometry
- Packaging – primary and secondary packs.
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 or functionality issues you might have.
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