Testing of porous structure and porous coatings for medical devices

元素为施用牙科和整形外科植入物的多孔结构和多孔涂层提供机械和冶金测试。不同类型的涂层包括可再吸收的爆发介质（RBM），钛等离子体喷雾（TPA），羟基磷灰石（HA），电子束熔化（EBM）和直接金属激光烧结（DML）。

用作涂层的多孔材料通常应用于医疗装置以支持植入物的生物固定。较新技术还允许直接整合设备基础材料中的多孔结构。yabo娱乐vip

To bring an implant with a porous coating to market, there are a number of tests that must be performed to verify the mechanical and metallurgical properties of the coating. These tests are beneficial in satisfying FDA or regulatory requirements, helping with research and development of new coating processes and technologies. They also provide insight to compare or validate coating suppliers.

机械测试多孔结构

机械测试包括磨损，静态和动态张力，剪切和弯曲。这些测试在专门制造的测试样品上进行，这取决于测试方法。

Shear Testing (ASTM F1044 & ASTM F1160)

The sample consists of a metallic cylinder that has a 0.75” outer diameter and a 1 to 1.25 inches in length, with the porous coating adhered to one flat side of the metal. The coated specimen is attached to an uncoated specimen and then loaded in shear either statically until failure or dynamically to a predetermined cycle count.

Tensile Testing (ASTM F1147)

拉伸测试使用由一侧涂覆的盘形样品组成的测试组件和一个未涂覆的，并在两个测试夹具之间粘合。具有1“外径的试样暴露于拉伸载荷直至失效，这意味着部件已经分开。

Abrasion Testing (ASTM F1978)

Abrasion testing is critical for porous structures, as poor integrity can have adverse effects in-vivo. The most commonly performed test is Taber abrasion, which consists of a circular sample repeatedly contacted by an abrasive wheel. Results are used for comparative purposes when evaluating coating types of suppliers or compared to general acceptance criteria set by a regulatory agency.

旋转梁疲劳（ASTM F1160）

Rotating beam testing consists of an hourglass-shaped, coated rod which is loaded about its long axis as a beam. During testing, the specimen’s surface material is subject to the greatest amount of stress, making this an ideal test for determining properties of a porous coating.

Coefficient of friction

Coefficient of friction testing consists of measuring both the static and dynamic frictional forces between a porous structure and either polyurethane bone analog, animal tissue, or human donor tissue. Static resistance is the force that is required to initiate motion, while dynamic resistance is the frictional force required to maintain motion. We perform coefficient of friction testing to internal procedures or client protocols.

多孔涂层的冶金测试

元件’s metallurgical laboratories perform a variety of evaluations on porous coating samples, including coating thickness, coating surface roughness, volume percent void, and morphology of pores.

Stereological Evaluation (ASTM F1854)

These test methods examine the various porous coatings adhered to nonporous medical implants. Substrates are evaluated using a digital image analysis system and custom software programming to determine the coating thickness, volume and percent void (between tissue interface and substrate interface).

Our trusted medical device testing allows your company to mitigate risk knowing that we are working diligently to help ensure your success and bring a safe product to market.

For more information about testing of porous structure and porous coating for medical devices or to request a quote,contact us today.