测试 of porous structure and porous coatings for medical devices

im体育APP provides mechanical and metallurgical testing for porous structures and porous coatings applied for dental and orthopedic surgical implants. The different types of coatings include resorbable blast media (RBM), 钛等离子喷涂(TPA), 羟磷灰石(HA), electron beam melting (EBM) and direct metal laser sintering (DMLS). 

A porous material used as coating is often applied to medical devices to support biological fixation of an implant. Newer technologies also allow direct integration of porous structures in the base materials of devices. 

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.

多孔结构的力学测试

机械测试 include abrasion, static and dynamic tension, shear, and bending. These tests are performed on specially-made test samples, which vary depending upon the test method.

剪切试验(ASTM F1044) & ASTM F1160)

The sample consists of a metallic cylinder that has a 0.75 "外径和1对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.

拉伸试验(ASTM F1147)

Tensile testing uses a test assembly made up of a disc-shaped sample with one side coated and one uncoated, 并连接在两个测试装置之间.  试验试样, 外径为1 ", is exposed to a tensile load until failure, 意思是组件分离了.   

磨损试验(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. 在测试过程中, 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.

摩擦系数

摩擦系数 testing consists of measuring both the static and dynamic frictional forces between a porous structure and either polyurethane bone analog, 动物组织, 或者人体捐献组织. 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.

多孔涂层的冶金试验

im体育APP的 冶金测试实验室 perform a variety of evaluations on porous coating samples, 包括涂层厚度, 涂层表面粗糙度, 体积空隙率, 以及孔隙的形态.

体视学评价(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, 立即im体育APP.