Medical Device Components Testing Using a Tapped Plate
The medical device industry is increasingly tailoring efforts to the testing of components and end products. A 90° pull test of the conducting tubing in a blood bag offers gripping challenges that are easily solved using clamps that are fixed to the threaded holes of our component test table. After the bag is oriented and fixed, an upper screw action grip with v-serrated faces is used to pull out the inlet tubing of the blood bag.
The component test table provides a high degree of flexibility for the operator due to its capability of using multiple combinations of fixation devices that accommodate most component geometry. The area of the plate is appropriately sized in order to offer fixation locations for a small to large array of products. The component test table is designed for mounting to our single- or dual-column testing systems.
Other common applications of the component test table include the testing of buttons employed on delivery systems, catheters, artificial organs, sub-assemblies, and any other product that requires a strength test of their components.
Records management compliance with FDA 21 CFR § 11 is non-negotiable for many Medical Device and Pharmaceutical companies. ComplianceBuilder™ is a stand-alone, add-on compliance solution that can be integrated with our Bluehill® Software, providing features necessary to meet the latest FDA 21 CFR § 11 regulations.
Screw side-action grips provide a very simple and efficient method for holding test specimens in a wide range of applications. The dual - acting design of 2710-100 series grips means that jaw faces can be adjusted to accommodate different specimen thicknesses. This ensures that the line of tensile force remains concentric with the grip body. They can be equipped with a selection of interchangeable grip jaw faces in various sizes and choice of surfaces including smooth ground, rubber-coated and serrated. Line contact and special coated faces are also available.The unique ‘snap-on’ jaw face attachment makes changing faces extremely quick and simple.
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Instron 3300 Series Universal Testing Systems for Tensile, Compression, Bend, and other material property tests.
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The component test plate is a large plate with an array of tapped holes that is useful for securing difficult-to-test components for a variety of tensile, compression, peel or other testing. It can be used with most universal testing systems.
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5900 Universal Testing Systems are engineered for precision, built for durability, and offer the flexibility for changing requirements. They are designed with standard and optional features that increase testing efficiency and improve the testing experience for the operator. A wide range of models are available for testing capacities from < 100N up to 600kN.
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For Medical Device and Pharmaceutical companies, records management compliance with FDA 21 CFR § 11 is non-negotiable. ComplianceBuilder™ (CB) is a stand-alone, add-on compliance solution that can be integrated with Instron’s Bluehill® Software to provide features necessary to meet the latest FDA 21 CFR § 11 regulations.
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