DIN EN ISO 9626:2015-03

This Draft International Standard provides requirements and test methods for the tube 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. This document specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (G10) to 0,18 mm (G34). This International Standard 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 does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.