ISO 8537

Smithers Pira tests sterile single-use insulin syringes to ISO 8537, assessing their characteristics and functional performance against the requirements set out in the standard.

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:

  • Cleanliness
  • 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

Through our sister company Smithers Rapra, we are also able to perform the following tests to this standard:

  • Lubricant – visibility and Quantity for syringes and needles
  • Compatibility tests between syringes and injection fluids- Resistivity, Spectrophotometry
  • Packaging – primary and secondary packs

Bespoke 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 programme to meet your specific testing requirements and resolve and design or functionality issues you might have.

For more information:

Medical Device Testing >

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