ISO 9626 Stainless Steel Needle Tubes for the Manufacturing of Medical Devices - Requirements and Test Methods

Material Testing

ISO 9626 Stainless Steel Needle Tubes for the Manufacturing of Medical Devices - Requirements and Test Methods

EUROLAB laboratory provides testing and compliance services within the scope of ISO 9626 standard. The ISO 9626 standard, developed by the International Organization for Standardization (ISO), applies to hard stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily intended for human use.

ISO 9626 Stainless Steel Needle Tubes for the Manufacturing of Medical Devices - Requirements and Test Methods

It provides the requirements and test methods for tubes manufactured for needles as components used in medical devices. Additional performance testing on the pipe direction may be required when the component is included in the ready-to-use device.

Specifies the dimensions and mechanical properties of steel pipes in metric sizes specified from 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).

It does not apply to flexible stainless steel tubing as the mechanical properties differ from those specified for rigid tubing in ISO 9626. However, manufacturers and buyers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626.

The pipes will be made of stainless steel. Selected materials, this International
It will comply with the requirements specified in the standard. The specific choice of stainless steel material should be made taking into account the intended use, for example prolonged contact with drugs, and biocompatibility requirements should be considered. A risk-based approach will be applied to pipe selection for a specific application and intended use.

Surface Quality and Visual Appearance

When inspected with normal or corrected vision, the outer surface of the pipe will be smooth and free of defects. Surface finish properties may differ depending on the final function of the medical device; in such cases, the medical device manufacturer should prepare specific specifications for surface finishing. When viewed with normal or corrected vision, the needle tube should appear straight and of regular roundness.

Cleaning

When inspected with normal or corrected vision, the surfaces of the pipe should be free of metal contamination and processing agents. Cleaning characteristics may differ depending on the final function of the medical device; in such cases, the medical device manufacturer must prepare specific specifications for cleaning.

Acidity and Alkalinity Limits

When determined with a laboratory pH meter and using a general purpose electrode, the pH of a prepared extract should be within one pH unit of the pH unit of the control liquid.

Size Description

The pipe size will be indicated by the nominal outside diameter (ie the specified metric size) expressed in millimeters, the corresponding gauge size (eg G31 or 31G) and the wall thickness. eg 0,25mm (31G) ETW.

Among the services provided by our organization within the framework of material testing services, there are also ISO 9626 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

Whatsapp