ISO 9626 : 2-Point Bending Fixture for Needles Test Machine (break resistance)
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.
It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.
The break resistance of injection needles is determined to standard ISO 9626 (Annex C) using a 2-point flexure test. The needle is held on one side and the free side is bent at a defined angle.
To test the stiffness of the needle tubing to standard ISO 9626 (Annex B), a 3-point flexure test kit is used. A defined flexure separation that corresponds to the needle gauge must be selected.