The ISO 7864 standard is drafted for single-use hypodermic needles primarily for use on humans to inject or withdraw fluids. The needles are meant to mate with syringes that have a 6% Luer conical fitting which is found in ISO 80369-7. ISO is the International Organization for Standardization. They expertly develop and publish standards for manufacturers, sellers, buyers, and any other organization that uses or regulates quality standards. In this case, we are referring to quality management of dimensional standards that could affect the way medical devices such as hypodermic needles handle flow rate and force, each necessary for optimal fluid delivery or removal.
When considering the design of minimally invasive hypodermic needles, geometry always plays a part. Different geometries, for instance of the stylet and cannula, can affect the sharpness and performance. The stylet is defined as a rod that fills the inner tube of hypodermic needles. It is ground and polished to match the sharp end of the needle. The cannula is the stainless-steel tubing or the needle itself. ISO 7864 dimensional standards define the tube size, tube length, and wall thickness for gage determination. The tips of cannula are designed with different shapes to achieve different results. Needle insertion is essentially tissue cutting. Therefore, the geometry can affect the pain and trauma experienced by the patient.
The Chiba design pictured here is a commonly used needle with a 30-degree, beveled tip. Chiba needles are more precise, offer more comfort to the patient, and are often used in procedures needing a high degree of safety.
Oftentimes, ISO 7864 dimensional standards can be inspected using video measurement systems, field of view equipment, or coordinate measuring machines (cmm). Vision systems quickly show edges and corners with clarity, including the detection of burrs or other manufacturing defects. These systems work well for examining the cannula or outer tube. Industrial computed tomography (CT) scanning services become essential for the inspection of hypodermic needles when hard to reach areas cannot be accessed or picked up by the more traditional dimensional inspection techniques. If the length of the stylet within the cannula is needed, the only way to access it is employing industrial ct scanning services. Let’s say a customer wants to know the primary bevel angle or the angle of the stylet relative to the angle of the cannula, but the stylet is recessed too far back to access it with even the smallest cmm touch probe. Industrial CT scanning can:
In the example below, industrial ct scanning is used to determine the primary bevel angle, the secondary bevel angle, and the bevel rotation angle:
Whether you are trying to confirm ISO 7864 dimensional standards on your hypodermic needles or you’re looking to improve product design or functionality to surpass your competitors to market, Nel PreTech Corporation can find the right solution for the insight and data you need when you need it. Get a quote or contact us for more details.
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