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Leak Detection of Medical Devices

European standards as applied to medical devices demand the 100% testing of important parameters critical to the performance of the product. These important tests include leakage, flow rate and blockage.

The use of Furness Controls' Leak Detection and Flow measuring instrumentation will ensure product performance, carrying out the vital tests on production lines. For example the testing of Epidural sets, where typically 1 mm diameter tubes must be tested to ensure that 3 drug-dispensing holes at the end of the tube are open and will lead to the expected delivery of the anesthetic drug to the patient.

The Furness Controls instrumentation is set to check that the right flow rate exists on every part tested. Another test is the detection of passageways in Tracheotomy tubes and leak detection in intravenous drip bags. Other parts tested include Drainage Bottle/Bags, Needles, Catheters, Filters, Inhalers, Valves and artificial kidneys.

As specialists in the production testing of medical devices Furness Controls have successfully tested a variety of products from Catheters, Tracheal Tubes, Drainage bottles and bags, Needles, filters and I.V. sets, ensuring that leakage and blockage are eliminated and that flows are within tolerance. Pressures used for testing are often around 7 PSI and flows from 50 cc/min up to several litres/min in some cases. Cycle times are often less than one second.

Using modern non-destructive test methods ensures a high quality product is sent into the market place. Furness Controls manufacture a full range of instrumentation aimed at the production line testing of medical devices and can be consulted on any application.

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