Standard name: Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016).

Applicable medical devices:

This standard specifies the requirements which need to be met by sterile single-use hypodermic needles of the metric sizes 0.18 mm to 1.2 mm. It does not apply to devices which are already covered by their own standard (such as pen needles and dental needles).

Testing capabilities to ISO 7864 include:

  • Size – tubular and tapered needle
  • Conical fitting
  • Needle tube – length, freedom from defects and lubricant
  • Needle point
  • Bond between hub and needle tube
  • Lumen patency
  • Fragmentation test for medical needles
  • Penetration force and drag force
  • Determination of flow rate through the needle
  • Bond strength of the hypodermic needles.

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

Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of ISO 7864:2016.

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