ISO 9626 Stainless Steel Needle Tubing for Use in the Manufacture of Medical Devices - Requirements and Test Methods

The standard "ISO 9626 Stainless steel needle tubing for use in the manufacture of medical devices - Requirements and test methods" published by the International Organization for Standardization (ISO) describes the requirements for rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This standard provides requirements and test methods for tubing manufactured for needles as components used in medical devices. Additional performance tests related to tubing orientation may be required when the component is incorporated into the ready-to-use device.

This standard covers the dimensions and mechanical properties of steel tubing in metric sizes designated as 3,4 mm (10 Gauge) through 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 standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this standard.

For the purposes of this standard, the following terms and definitions apply:

• The designated metric size is the outside diameter designation of the pipe as defined in the table provided in the standard and is expressed in millimeters.
• Gauge is the old definition of dimension. A given gauge size corresponds to a designated metric dimension that defines the limits for outside diameters.
• Wall thickness refers to the material thickness between the inner and outer diameter of the pipe. This value is expressed as normal wall, thin wall, very thin wall and ultra thin wall as indicated in the table.

In terms of material, the pipes should be made of stainless steels listed in the standard “ISO 15510 Stainless steels - Chemical composition”. The selected materials should comply with the requirements specified in this standard. The selection of the specific stainless steel material should be made considering the intended use, for example long-term contact with drugs, and the biocompatibility requirements should be taken into account. Appropriate biocompatibility requirements are included in the standard “ISO 10993-1 Biological evaluation of medical devices - Part 1: Requirements and general principles for the assessment of biological safety within a risk management process”.

The requirements in this standard are specified as follows:

• General: A risk-based approach should be applied to selecting pipe for a specific application and intended use.
• Surface quality and visual appearance: When viewed with normal or corrected vision, the external surface of the tube should be smooth and free from defects. Surface quality specifications may vary depending on the ultimate function of the medical device; in such cases, the medical device manufacturer must prepare special specifications for surface quality. When viewed with normal or corrected vision, the needle tube should appear straight and of regular roundness.
• Cleanliness: When viewed with normal or corrected vision, the surfaces of the tube should be free of metal contaminants and processing agents. Cleaning specifications may vary depending on the ultimate function of the medical device. In such cases, the medical device manufacturer should prepare special specifications for cleaning.
• The pH of an extract prepared in accordance with the standard annex for acidity and alkalinity limits should be within one pH unit of the pH of the control liquid when determined using a laboratory pH meter and a general-purpose electrode (Annex A).
• Acidity and alkalinity limits: The pH of an extract prepared in accordance with the annex of this standard shall be within one pH unit of the pH of the control liquid when determined using a laboratory pH meter and a general-purpose electrode (Annex A).
• Size definition: Pipe size is specified by the nominal outside diameter expressed in millimeters (i.e. specified metric size), the corresponding gauge size (e.g. G31 or 31G), and the wall thickness.
• Dimensions: Pipe dimensions must be as given in the table titled “Pipe dimensions” in the standard.
• Sample size: Where sampling is applicable, sample sizes should be determined based on risk assessment principles and included according to the tube specification and intended use.
• Hardness: when tested in accordance with the annex to this standard, the tube shall exhibit a deviation not greater than the relevant value given in the table entitled “Hardness test conditions” (Annex B). For tubes for which hardness test parameters are not defined in this standard, the medical device manufacturer shall prepare specific hardness requirements based on a risk assessment of the final intended use of the tube. Consideration should be given to the intended use of the tube in the final product to determine whether additional testing is required.

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