How is the Medical Industry Taking Advantage of Industrial CT Scanning?

Industrial CT scanning enhances dimensional testing for Luer connectors. Also learn about axial force, torque, and pressure testing to meet ISO 80369 standards.

Carter Aldridge
Carter Aldridge

Precision is the key to success in the medical field. No matter how small the components are, they must undergo rigorous quality control procedures to ensure they are not harmful to patients. One such component is the Luer connector. It may seem like a trivial thing, but it plays a big part in the medical device industry. These connectors, used in the assembly of syringes and IV lines, should be tested for safety and compliance.

This is where industrial CT scanning services are making a difference.

What is Industrial CT Scanning?

The idea and concept of industrial CT (Computed Tomography) scanning are the same as those in medical CT scans. CT scanning is a method by which the inner structure of a part can be visualised without opening the part.

CT scanning makes it possible to observe small defects, take measurements of the inside of parts, and understand how different pieces are connected. This is important for parts like Luers, where the precision and tightness of the seal play an important role.

Mechanical & Dimensional Testing of Luers

Manufacturers of medical devices strive to meet quality requirements. They are obliged to comply with ISO 80369 for Luers, a standard that refers to the physical and dimensional testing of the small-bore connectors. These tests are not only about measuring, they also include the connector's strength, its reaction under torque force, and the ability to withstand pressure without leaking.

1. Axial Force Testing

This test measures the amount of pulling force a connector can withstand along its length before it breaks or comes apart. A special machine applies a predetermined axial load to a reference connector for approximately 10-15 seconds. If the connector remains securely attached to the reference connector, it passes the test.

2. Torque Testing

Torque testing determines the extent to which a Luer connector can be turned and twisted. It is used to determine if Luer lock connectors can maintain a seal and stay in place when attached. A torque testing machine applies a rotational force either clockwise or counterclockwise with a specified torque range from the ISO 80369 standard. Through observation, the connector is checked for thread damage or separation.

3. Pressure Decay and Leakage Testing

Conducting leakage tests with both air and liquid is important in the medical sphere. The presence of even a small leak may lead to very severe adverse events, specifically in drug delivery and blood transfers.

The pressure decay and leak testing on Luer connectors specifically uses air to test pressure. When the air flow is shut off, a leak tester measures any decay or decrease in pressure within the part. If pressure loss stays within the defined limits of the ISO 80369 standard, then the connector is determined to be leak-proof.

4. Dimensional Testing with Greater Accuracy

CT scanning can effectively perform the traditional Luer dimensional testing by using digital calipers within the software to determine internal dimensions. CT is better than hand-operated or surface-only tools in this respect, as it gauges the internal parts without them being cut open. Traditional tools only offer line-of-sight. CT can be used for non-line-of-sight imaging, is faster, more accurate, and removes operator bias.

Luer diameter measurement with CT software
Luer Diameter Measurement

A Safer and Smarter Way to Test

Industrial CT scanning services help medical companies become more efficient in the way they operate. This method helps them to save time, minimize waste, reduce costs, and gain insight into the performance of their products.

Proactive Quality Assurance

Medical devices are getting smaller and more intricate, which increases the need for precision. Industrial CT scanning and mechanical testing services give the medical industry a transparent look into their products using the ISO standard. Computed tomography scanning is the tool boosting quality and safety in every sphere.

The concept is not just about inspecting a part from the inside. It is about being proactive and ensuring that every device meets the highest standards, every single time.

Contact Nel PreTech for a free quote or consultation on your next medical device or Luer testing job.

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