IMR Materials Testing Technical Blog

A Comprehensive Guide to Medical Device Coatings Evaluation

Medical devices often require specialized coatings to enhance performance, longevity, and safety.  Coatings can provide corrosion protection, lubricity, support of bone infiltration, and increased durability.  To ensure your medical device operates at peak performance, selecting the correct coating is essential. 

A variety of available coating options and specific requirements for each application can make choosing the correct coating seem complex, however, partnering with a trusted laboratory can make the decision making process seamless. Evaluations are performed to determine the most cost effective solution, and one that optimizes device performance, extending it’s lifespan. 

The Importance of Comprehensive Coating Testing

Evaluation laboratories should offer a variety of testing services to meet the needs of unique medical devices. Testing capabilities should include:

Mechanical Testing

Assess the durability of the coating under the mechanical stresses of wear, fatigue, and friction.

Metallurgical Evaluation

Analyze the microstructure of a coating to ensure integrity and proper bonding.

Corrosion Testing

Assess coating ability to protect the device from degradation caused by environmental factors.

Morphology Testing

Examine the surface features of a coating.

Composition Testing

Verify the chemical makeup of a coating to ensure it meets required specifications.

With our variety of testing options, IMR Test Labs is a coating evaluation partner that can identify the best option for determining a coating with optimal performance under real-world conditions. Our team of experts utilize state-of-the-art testing tools and techniques for reliable and compliant solutions.

Coating Evaluations for the Medical Device Industry

Medical device coatings require advanced properties to meet exceptionally high standards in order to remain current with medical procedures and equipment in the field:

Durability

Coatings must resist wear and tear over time in harsh bodily environments.

Corrosion Resistance

Moisture and bodily fluids are corrosive to coatings.

Biocompatibility

Coatings must be safe for human tissue and fluid interaction without triggering reactions.

Sterility

Withstanding sterilization processes ensures coatings maintain patient safety.

IMR Test Labs coating evaluation services can test parylene, hydroxyapatite, beta-tri-calcium phosphate, titanium and more. Coatings are used in dental applications. for cardiovascular devices and orthopedic implants.

Along with compliance with regulatory standards, evaluations support both ongoing quality control for mass production and research and development.

Key Factors to Consider When Conducting Coating Evaluations

A coating’s properties must not only be functional, but be in compliance with medical regulations. Key aspects to consider include:

Chemical Purity

Assess the presence of impurities in the medical device coating which impact biocompatibility or performance.

Adhesion Properties

Determine secure attachment of the medical device during the mechanical stress and thermal cycling of operational conditions.

Thickness

Assess thickness to determine mechanical integrity while maintaining device functionality.

ASTM Standards for Medical Device Coatings

Porous coatings on orthopedic and dental implants promote bone infiltration for better biological fixation. Coatings endure shear stresses and must be evaluated according to ASTM F1044 and ASTM F1160 standards. These standards are for plasma-sprayed titanium and hydroxyapatite coatings. IMR Test Labs tests sample performance under constant or cyclic shear stresses to determine shear strength and fatigue life. 

• ASTM F1044 – Shear testing of calcium phosphate and metallic coatings
• ASTM F1160 – Shear and bending fatigue testing of medical coatings

These tests determine the adhesive or cohesive strength of coatings on metal or plastic substrates, providing essential data for regulatory requirements or coating evaluations.

Partnering with IMR Test Labs for Medical Device Coatings Testing

For more than 20 years, IMR Test Labs has been a leader in the testing industry, offering a full range of plating and coating evaluation services tailored to the medical device sector, along with energy, automotive, oil and gas, and aerospace industries. 

Our cutting-edge equipment and expert team provide insight into the best coating solutions for your medical devices. Whether you’re in the early stages of R&D or need third-party testing to meet regulatory standards, we’re here to help.  

Speak to a member of our team to learn more about how IMR Test Labs can support your medical device coating evaluations or request a quote today.