Testing of Metals Ensures Quality in Medical Implants and Instruments

As a result of advancements in materials technology in the medical implant and surgical instrumentation industries, Laboratory Testing Inc. (LTI) has become a major supplier of metals testing and materials analysis services for leading manufacturers of these devices. Medical manufacturers have become acutely aware of the need to use quality metals and materials in their products for guaranteed performance, durability and long-term reliability. To ensure that quality is maintained throughout the manufacturing process, raw materials and metal products, machined parts and fabricated products may go through a number of nondestructive testing and materials testing procedures for information and certification.

Through nondestructive testing, metals testing and materials analysis such as mechanical testing, chemical analysis and metallography services performed at Laboratory Testing Inc., manufacturers get answers about mechanical properties, microscopic and subsurface flaws, material composition, corrosion susceptibility and more. Testing and inspection services such as tensile, bend, ultrasonic, and salt spray testing, ICP analysis, X-ray, magnetic particle and liquid penetrant inspections are all relied on for valuable results and answers.

For example, various materials are tested from the raw materials stage up to the final cleaning and packaging stages. Small diameter, heavy wall metal tubing used to manufacture bone screws for joint replacement and spinal column surgeries is a product frequently tested. Chemical, physical and corrosion-resistant attributes are verified on representative samples using standard mechanical testing, chemical analysis and corrosion testing methods. Nondestructive test methods, such as liquid penetrant and immersion ultrasonics are typically used to identify surface and near-surface flaws and inconsistencies in wall thickness.

Laboratory Testing Inc. was challenged by a major medical manufacturer to develop a nondestructive ultrasonic testing procedure that would adequately and reliably detect longitudinal and transverse oriented defects as small as.004 inch in depth in heavy wall metal tubing, with outside diameter to inside diameter rations typically greater than 2.0 to 7.0. Using reference standards containing EDM notches from the various sized materials, LTI was able to confirm both the detectability and reliability of the ultrasonic testing. Further confirmation was achieved with materials testing during production by metallographic sectioning and examination of any areas containing indications exceeding the ultrasonic reference level.

Ultrasonics are also used to verify the wall thickness and run-out (TIR) of the materials, which is a critical characteristic of the material prior to threading both the inside and outside diameters. Depending on the material type, liquid penetrant examinations are performed on the tubing in the as-drawn condition and in the manufacturer’s final machined stage to further detect possible discontinuities.

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