Evaluation of Medical Equipment/Implant Materials

Evaluation of Medical Equipment/Implant Materials

Outline of Evaluation of Medical Equipment/Implant Materials

The first Japanese laboratory of ISO 17025 accreditation. (mechanical testing)

ISO17025 accreditation

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.

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

Example of Evaluation of Medical Equipment/Implant Materials

Orthopedic Implants

Spinal Implants

Dental Implants

Intramedullary Pins

Hip Joints

Knee Joints

Chemical Analysis

  • Evaluating the relative extent of oxidation in ultra-high-molecular-weight polyethylene fabricate forms intended for surgical implants

    Evaluating the relative extent of oxidation in ultra-high-molecular-weight polyethylene fabricate forms intended for surgical implants

Screws

Stents and Catheters

Wires

Failure Analysis

Chemical Analysis

Corrosion Resistance Evaluation (Corrosion Evaluation)

Surface Observation (Surface Roughness)

MR Compliance Testing

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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

Mechanism Safety Tests

Mechanism Safety Tests

Fatigue tests, tensile tests, bending tests, hardness tests, surface roughness tests

Multi-lingual Translation Service

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

[ JIS T 0302 ]
Testing method for corrosion resistance of metallic biomaterials by anodic polarization measurement
[ JIS T 0303 ]
Testing method for wear resistance of materials for artificial joints by pin-on-disk method
[ JIS T 0304 ]
Testing method for metal release from metallic biomaterials
[ JIS T 0305 ]
Testing method for galvanic corrosion in pseudo physiological solution
[ JIS T 0306 ]
Analysis of state for passive film formed on metallic biomaterials by X-ray photoelectron spectroscopy
[ JIS T 0309 ]
Test method for fatigue properties of metallic biomaterials
[ JIS T 0310 ]
Test method for notch sensitivity and fatigue crack growth properties of metallic biomaterials
[ JIS T 0311 ]
Mechanical testing methods for metallic bone screws
[ JIS T 0312 ]
Testing methods for bending properties of metallic osteosynthesis devices
[ JIS T 0313 ]
Testing methods for compression bending properties of metallic osteosynthesis devices

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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