OSTEOSYNTHESIS PRODUCT TESTING

In bone fractures, the fractured areas need to be held together for healing. Plates, screws, pins, wires, external fixators, and biodegradable plates and screws can be used to hold the fractured area together. The strength of the osteosynthesis products used in the body is crucial for complete healing and the preservation of patient health.

International standards and regulations have published test standards to determine the durability of the products used. The main mechanical tests we perform, adhering to the ISO 17025 standard, are as follows:

  • Flat Bone Plates: ASTM F382
  • Angled Orthopedic Fixation: ASTM F384
  • Intramedullary Devices: ASTM F1264
  • External Fixators: ASTM F1541
  • Biodegradable Plates and Screws: ASTM F2502
  • Bone Screws: ASTM F543
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SAMPLE STANDARD EXPLANATION
RECORD ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
ANGLED RECORD ASTM F384 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
BONE SCREWS ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
METALLIC BONE STAPLES ASTM F564 Standard Specification and Test Methods for Metallic Bone Staples
INTRAMEDULAR NAIL AND SCREW ASTM F1264 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
EXTERNAL FIXATORS ASTM F1541 Standard Specification and Test Methods for External Skeletal Fixation Devices
BIODEGRADABLE PLATE AND SCREW ASTM F2502 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
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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

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