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Evaluation of Medical Equipment/Implant Materials

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Outline of Evaluation of Medical Equipment/Implant Materials

  • JFE-TEC can provide a wide range of services, from evaluation tests for medical equipment, beginning with implant materials, to investigation of the causes of damage and defects and mechanical safety testing required for pharmaceutical applications.

    • Tests for approval applications (pharmaceutical applications) for medical equipment
    • Evaluation tests of orthopedic implants in accordance with ASTM, ISO and JIS standards.
    • Various types of evaluation tests for dental implants
  • The first Japanese laboratory of ISO 17025 accreditation. (mechanical testing)

    Our Medical Device Testing Center has been accredited as an ISO17025 testing laboratory in the field of evaluation of implant materials.

    • We are the first certified domestic testing laboratory for medical devices (mechanical testing).

      For details, click here.

    • The first Japanese laboratory of ISO 17025 accreditation.

Example of Evaluation of Medical Equipment/Implant Materials

Orthopedic Implants

Material Testing

Spinal Implants

Dental Implants

Material Testing

Hip Joints

Material Tests

Knee Joints

Screws

Material Tests

Stents and Catheters

Wires

Failure Analysis

Material Tests

Chemical Analysis

Corrosion Resistance Evaluation (Corrosion Evaluation)

Surface Observation (Surface Roughness)

MR Compliance Testing

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Example details

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Content of Tests for Evaluation of Medical Equipment/Implant Materials (Guide to Commissioned Testing)

JFE-TEC proposes the optimum solution for each client's needs.

  • Physical Analysis
    Physical Analysis
    State analysis by X-ray photoelectron spectroscopy (XPS) of passivation film, X-ray diffraction
  • Failure Analysis
    Failure Analysis
    Investigation of causes of failure of orthopedic implants and steel medical products, failure analysis techniques for electronic components
  • Chemical Analysis
    Chemical Analysis
    Surface characteristics test (Ca/P ratio), elution tests of metallic biomaterials (ICP-MS), microanalysis (trace analysis) of organic materials/chemicals
  • Nondestructive Testing
    Nondestructive Testing
    High precision stress measurement by infrared camera, radiographic testing, ultrasonic testing, eddy current testing
  • Finite Element Analysis (FEM)
    Finite Element Analysis (FEM)
    Stress analysis of actual behavior by collecting/combining data such as results of vibration test, fatigue test, etc.
  • Corrosion Resistance Evaluation
    Corrosion Resistance Evaluation
    Corrosion resistance testing by anodic polarization test, galvanic corrosion test
  • Multi-lingual Translation Service
    Mechanism Safety Tests
    Fatigue tests, tensile tests, bending tests, hardness tests, surface roughness tests
  • Mechanism Safety Tests
    Multi-lingual Translation Service
    Translation of test reports (for example, under ASTM standards, ISO standards, etc.) into English and other languages

Tests of Orthopedic Implants in accordance with JIS Standards

Reference Standards for Implant Tests

Guidelines for materials to be attached when submitting applications for approval of medical equipment
(Artificial hip joints, artificial knee joints, spinal fixation devices, orthopedic implants, intramedullary nails for internal fixation, dental implants, compression hip plates for internal fixation, cables for internal fixation, pins for internal fixation, screws for internal fixation)

For test reports in English and other languages, just ask JFE-TEC!

JFE-TEC can also prepare test reports conforming to ASTM, ISO and other standards in English as well as Japanese.

We provide translation services for a wide range of languages. Please ask when making an inquiry or request!

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