Medical devices need to undergo stringent testing procedures, unlike most mass-produced products. Owing to the availability of modern testing techniques, the quality standard has been strict. Medical devices need to move through the standards set by the Food and Drug Administration, such as blood filters, catheters, diagnostic probes, syringes, ventilator tubes, and other objects. Leak testing of good accuracy, sensitivity, repeatability, and reproducibility with critical inspecting methods is of great significance. Consequently, medical instruments have a mechanism for carrying fluids or chemicals that needs 100% accurate leakproof testing. Mikro offers exceptional leak testing equipment for the medical sectors entailing the following;
Mikro manufactures a full line of high-performance instruments that are ideal for catheter testing. customizable systems put forth many cath test capabilities for non-compliant balloon catheters, multi-lumen catheters, and more. With your insights we will determine which test device is perfect for your catheter testing needs. Catheter testing equipment is calibrated to ensure it withholds traceable standards and will store a tons of data to provide a comprehensive history of potential results. For complete catheter testing and data collection, look no further than Mirko. Contact us today to find the right medical testing system for your needs.
2. Syringes & Needle
A syringe is a reciprocating pump that uses a tube with a closely fitted plunger that is used at the end of the tube to remove or pull liquid or gas through the opening. To direct flow in and out of the syringe barrel, the opening must be equipped with a needle, nozzle, or tubing. It is important that the syringe tip correctly flows fluid through the barrel and that the nozzle, tubing, and seal of the plunger do not leak. If a normal slip tip, catheter tip, eccentric tip, or an insulin syringe needs to be leak tested by your company, Mikro will help you develop a leak or flow test solution to ensure that your syringe does not leak.
3. Oxygen Pumps
Vacuum testing (outside-in), pressure testing (inside-out), and eventually pressure/vacuum testing, are three primary techniques for leak testing components using helium. In general, the method of detection should be chosen whenever possible on the basis of the working conditions of the pieces to be tested. During the test, it is important to retain the same pressure conditions as would occur during the actual usage of the part. Leak testing can be carried out on vacuum systems and oxygen pumps under the same conditions as their working conditions. With a handheld leak detector, oxygen pumps are tested. In general, the leak detector is connected to the vacuum pump device.
4. Chemotherapy Pumps
One of the ways that you can receive your chemotherapy is through chemotherapy pumps. In a regulated manner, they allow you to get chemo. Infusion pumps are also called chemotherapy pumps. A nurse will attach a pump while you have chemo by a central line or a PICC line. It can very carefully deliver a controlled quantity of medications into the bloodstream. Different forms of pumps exist. Chemotherapy Pumps leak test is important to ensure that no cracks, rips, or pinholes are produced during processing that could cause drug leakage and the pump not to operate properly. These different quality tests can be attained with various Mikro leak and flow testing instruments.
5. Blood Bags
In many healthcare applications today, surgical solutions and blood bags are used. They often have tubes or ports leaving the bags inside and secured between the flat sheets, typically made of sheets of PVC, EVA or polyolefin that are sealed at their perimeter edges. Testing each bag for leakage is crucial and the automated test must overcome the complexities of the lightweight material, the possible output of varying sizes and the cycle time and process control requirements of the producer. Mikro has considerable expertise in delivering these types of leak test solutions and an overview of such research is detailed in this application note.
Mikro has designed and manufactured leak tecting equipments in order to give the customer the ability to 100% leak test medical and respiratory filters within their production environment. We developed this system alongside the client to allow them to test, heat stamp and log the results for a range of respiratory air filters.
Ventilators are very reliant on accurate monitoring for leaks. Through injecting oxygen through a hose via a patient’s windpipe into their lungs and extracting carbon dioxide, they imitate the way people breathe naturally. An air leak in a ventilator interferes with the capacity of the system to respond adequately to the intermittent breaths of the patient as the leak throws off the scheduled cycle of the ventilator, raising the breathing efforts of the patient. Inside a ventilator, there are several parts that should be leak or flow tested separately to ensure that the right leak rate specifications, such as hoses, valves, sensors, regulators, filters or reservoirs, are met.
Medical devices are provided in different sizes and often contain specific geometries such as cylinders, tubing, and other elements that can make it more difficult to test the equipment. Test pressure can also be affected by the elasticity and durability of silicone and other components commonly used in medical devices. Mikro has crafted medical device leak testers to provide proper sealing and an accurate amount of sensitivity and pressure to overcome these problems and achieve accurate test results. The selection of the appropriate equipment and medical leak monitoring procedures is also important.