In our last post, we discussed the changes made to ISO 7864:2016, the standard for sterile hypodermic needles for single use. However, ISO 7864 was not the only hypodermic needle standard updated in 2016. ISO 9626:2016 – Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods, which applies to the rigid stainless steel needle tubing used in the manufacturing of hypodermic needles, also underwent a recent revision.
ISO 9626:2016 standardizes the manufacture of hypodermic needles by specifying the dimensions and mechanical properties of steel tubing in 25 designated metric sizes, falling incrementally from 3.4 mm (10 Gauge) to 0.18 mm (34 Gauge).
However, it is also worth noting that, while the manufacture of hypodermic needles is the primary purpose of the steel needle tubing specified in the document, ISO 9626:2016 is applicable for use during the manufacture of other medical devices that use steel needle tubing as a component. The standard calls for these steel tubes, regardless of their specific use, to be made of stainless steels listed in ISO 15510:2014 – Stainless steels – Chemical composition, and, when finished, in addition to being durable and reliable, to be of one of the 25 designated gauges, clean, within one pH unit of the fluid used, and smooth and free of defects.
The means to achieve the level of quality noted within the standard is through compliance with the annexes of the document. Each annex of ISO 9626:2016 covers a different testing procedure that makes use of a sample needle and fluid to attain each needed attribute in the manufactured medical device. These include: methods for preparation of extracts (Annex A), test method for stiffness of tubing (Annex B), test method for resistance of tubing to breakage (Annex C), test method for resistance to corrosion (Annex D), and rationale with respect to test method for stiffness of tubing (Annex E).
For owners of the past version of the document (ISO 9626:1991), there have been several integral changes to the revision that make its acquisition a necessity. These changes are:
a) addition of specifications for stainless steel needle tubing for metric sizes 0.18 mm, 0.2 mm, 0.23 mm, and 0.25 mm and to reflect the introduction of thinner tubing to allow greater comfort when injecting, particularly for infants and in pediatric use;
b) addition of wall thickness designations beyond regular-walled and thin-walled tubing;
c) addition of minimum inner diameters for additional items where possible;
d) revision of the means of specifying the steels to be used;
e) revision of the table of tubing dimensions and stiffness parameters.
ISO 9626:2016 – Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods is now available on the ANSI Webstore.