Needle Testing

Needle Sharpness Testing

Currently, no industry standard exists for evaluating needle sharpness, however, the engineers in DDL’s Product & Materials Division have developed and validated an internal test method for assessing this important performance characteristic correlated to patient comfort during administration.

DDL has used this test method to assist customers in performing competitive analysis of the performance of their products vs competitors in order to gain insights about product design, manufacturing processes and ultimately improve product quality.

ISO Needle Testing

Two of the primary ISO standards applicable to needles are ISO 7864 and ISO 9626.

ISO 7864 addresses single use hypodermic needles and tests for:

  • Cleanliness
  • Limits for Acidity and Alkalinity
  • Limits for Extractable Metals
  • Size Designation
  • Tolerances on Length
  • Freedom from Defects
  • Lubricants
  • Needle Point
  • Bond between Hub and Needle Tube
  • Patency of Lumen
  • Primary and Secondary Container Packaging

ISO 9626 defines inspection and test requirements for stainless steel hypodermic needle tubing, including:

  • Materials
  • Surface Finish
  • Cleanliness
  • Acidity and Alkalinity
  • Size Designation
  • Dimensions
  • Stiffness
  • Resistance to Breakage
  • Resistance to Corrosion

Test Standards for Needle Testing

  • ISO 7864 – Sterile, hypodermic needles for single use
  • ISO 9626 – Stainless steel needle tubing for manufacture of medical devices
  • JIS 3209 – Sterile Injection Needles
  • JIS 3228 – Biopsy needles for single use

Please contact us for more information on Needle Testing.