EN 9626 Stainless Steel Hypodermic Tubes for the Manufacturing of Medical Devices - Requirements and Test Methods

This international standard provides requirements and test methods for tubing manufactured in the form of cannulas for use as components in medical devices. Additional performance testing of the tubing may be required when the component is included in the finished product.

The purpose of this international standard is to:

• Includes specifications for 0,18mm, 0,2mm, 0,23mm, and 0,25mm metric stainless steel hypodermic tubing and considerations for using thinner tubing for greater comfort during injection, particularly in infants and pediatric use;
• Adding wall thickness definitions in addition to normal wall and thin wall;
• Include minimum inside diameters for other products where possible;
• Revision of the way of determining the steels to be used.

This international standard applies to hard stainless steel tubing for the manufacture of hypodermic needles and other medical devices primarily for human use.

It does not apply to flexible hypodermic tubing made of stainless steel, as its mechanical properties differ from those specified for rigid tubing in this international standard. However, manufacturers and buyers of flexible hypotubes are encouraged to use the dimensional specifications of this international standard.

EUROLAB assists manufacturers with EN 9626 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.