Needle Testing

Two of the major needle testing standards 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 addresses tubing material and tests for:

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

Currently, no test standard exists for evaluating needle sharpness.  However, the engineers in DDL’s Product & Materials Division work with customers to define custom protocols for investigating this important aspect of needles.

ISO 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

Question about Needle Testing? You can also call us at 1-800-229-4235.