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Particle Analysis

Service Overview

Particle analysis is commonly performed on the wear particulates gathered from an implant wear test or a pin-on-disc test. Often, these particles are generated from the polyethylene component, or other materials depending on the device and design. A sample of the test fluid may be collected near the beginning and at the end of the test. Fluid samples are then processed for particle characterization through chemical digestion, filtration, microscopic imaging, and processing.

Characterizing wear particulates is critical for understanding material behaviour, implant performance, and immunologic response.

Additional Information

What equipment do we use for carrying out particle characterization?

Filtered particles can be imaged using our scanning electron microscope (SEM) or our KEYENCE high-definition digital microscope. Particles imaged by the SEM are sputter coated with gold in a controlled vacuum gas environment for accurate detection specific for polyethylene particles. Analysis with the SEM may also include energy-dispersive x-ray spectroscopy (EDS) for elemental composition verification of particles.

How are wear particles characterized?

Wear particles are characterized through advanced image processing software. Particles are auto-detected though manual greyscale thresholding and bit-plane filtering, then analyzed to determine precise particle size and morphology. Particle characterization may include measurements of area, aspect ratio, form factor, roundness, length, perimeter, ferret average, and equivalent circular diameter.

What other capabilities does our technology have?

Particle characterization may also be performed on other particulate materials such as unwanted debris generated from a medical device or instrument, and powders used in additive manufacturing. Assessing particulate morphology and size are critical for quality control, material assessment, and most importantly safety of the material or medical device.

Standards We Follow

ASTM F1877

Standard Practice for Characterization of Particles

ASTM F561

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

ASTM 3049

Standard Guide for Characterizing Properties of Metal Powders used for Additive Manufacturing Processes

ASTM F3335

Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

ISO 17853

Wear of Implant Materials – Polymer and Metal Wear Particles – Isolation and Characterization

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