BS EN ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods. | Status: Current, Under review

1 Scope 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. This International Standard 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. This International Standard 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 this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.