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The Need for a Systems Approach in Biomaterials Testing Many factors can affect the characterisation of biomaterials during testing. These include drugs administered prior to testing and shear stress on blood cells induced by different blood flows and specific blood donor conditions. Some of the misconceptions in testing are described here and serve to indicate that a systems approach, and not only individual test parameters, is best when testing for biocompatibility. more>>> |
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Force Testing Medical Tubing Force testing in the design and production of medical tubing is an essential ingredient in the delivery of functional and consistently high quality devices. This article describes a range of typical tests, how they are performed and the benefits they offer. more>>> |
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Safety Testing of Medical Devices: IEC 62353 Explained The new IEC standard for the in-service and post repair testing of electromedical devices introduces new requirements. These and their implications are outlined. more>>> |
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Tube Flaring Systems |
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Tubing and Jacketing Materials [Old copy]The Sil-Kore family of tubing and jacketing materials has been developed by W. L. Gore & Associates Inc. to meet specific ergonomics and durability concerns of the medical device market. The innovative products provide very good lubricity, increase tensile strength and resistance to torsion deformation, and withstand several modes of sterilization, thus enhancing the ease of handling and the performance reliability of such clinical devices as light guides and electrophysiology catheters. Gore |
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Custom Silicone Product Manufacturing [Old copy]Helix Medical LLC offers partnership advantages to companies needing services in outsourced platinum-cured-silicone manufacturing. The company applies more than 20 years of experience to the extrusion, molding, assembly, and finished-goods packaging of silicone devices and components. It is a medical device manufacturer, so all products benefit from a quality system specified for finished medical devices, and from the application of GMP and ISO 13485 certifications. Experienced medical device engineering staff can provide technical assistance. Helix Medical LLC |
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Balloon Forming Equipment [Old copy]Machine Solutions Inc. offers a catheter balloon molding/forming machine whose highly flexible process control interface facilitates rapid development of optimal balloon process parameters. The unique heating controls afford great flexibility in process development, including spot heating and uniform heating of the entire mold. The finished molded product will have such optimized qualities as uniform shaft and taper wall thickness. The equipment's flexibility allows operation with various materials and both metal and glass molds. Machine Solutions |
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Thermoplastic Tubing [Old copy]An ISO-certified extrusion company with more than 15 years of experience, Precision Extrusion Inc. deals with most thermoplastic resins, from soft 20 Shore A thermoplastic rubber through rigid, high-temperature materials like PEEK. The company specializes in close-tolerance single-lumen, multilumen, and braided small-diameter tubing, including coextruded tubing. In-house tool design and manufacturing capabilities and a proprietary tool design make possible quick tool changes and tooling modifications, resulting in shorter lead times and lower costs for customers. Precision Extrusion Inc. |
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Tube Extrusion Line |
| Plastic Tubes and Films A range of medical-grade plastics consists of PVC-, polypropylene-, and EVA-based flexible films and tubing developed for a wide variety of critical medical device and packaging applications...more>>> |
Tube-Cutting Machine An electrochemical grinding (ECG) tube cutoff machines is suited for trimming bent or swaged tube ends and performing trim cuts on catheters, guidewires, cannulae, and other medical device components...more>>> |
Tubing Assemblies Thermoformed tubing assemblies can be custom designed with bends and coils to fit snugly without kinking into tight spaces...more>>> |
| Crossheads and In-Line Dies Crossheads and in-line dies can be used to produce precise, low-volume medical tubing with an inner diameter as small as 0.000508 cm...more>>> |
Thermoplastic Tubing Welder and Sealer Welding and sealing instruments have been introduced for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes...more>>> |
