COATING TESTS

Determining the adhesion strength and fatigue resistance of calcium phosphate and metallic coatings applied to improve the surface performance of medical devices is of critical importance. At ERA Management laboratories, the mechanical integrity of these coatings under clinical conditions is analyzed in accordance with international standards.

Our main test methods included in our accreditation scope, which verify your coating performance, are as follows:

  • Coating Shear Test: ASTM F1044
  • Coating Tension Test: ASTM F1147
  • Coating Fatigue Test: ASTM F1160
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SAMPLE STANDARD EXPLANATION
COATED SAMPLE ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
COATED SAMPLE ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
COATED SAMPLE ASTM F1160 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Coatings

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

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For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21


Let's start the process together.