MEDICAL EQUIPMENT EVALUATION TEST
Medical Device Evaluation Test
The medical field, one of the most active fields in research and development, is particularly promising and where large investments are being made. KMTL actively promotes collaboration in testing and analysis with the industry, academy and government, contributing to development in the industries. For the medical field, we have established a quality assurance system based on the quality management system (QMS) to support research and development of medical devices from the viewpoint of a testing laboratory. Our customers place high confidence in our testing according to the American Society for Testing and Materials (ASTM) and Japan Industrial Standards (JIS) as well as U.S. Food and Drug Administration (FDA) guidelines.
Fixture for Compatibility Testing in the MR environment
This equipment, designed and developed according to the ASTM standard, is used to measure the magnetically induced torque produced by the static magnetic field during magnetic resonance imaging on medical devices.。
Material Testing based on Medical Device Standards and Guidelines
For safety testing / conformance testing / performance testing / comparative testing / functional testing
| Tensile testing |
| Compression testing |
| Fatigue testing |
| Hardness testing |
| Fracture toughness testing |
| Pulling testing |
| Metallographic examination and other |
| Failure investigation |
| Services related to the above |
＊Standards: ASTM F (American Society for Testing and Materials), JIS T, and other standards for materials and devices
Examples of conducted tests
- ・Test Methods For Intervertebral Body Fusion Devices (ASTM F 2077-03)
- ・Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs (ASTM F 2346-05)
- ・Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials (ASTM F 2516-06)
- ・Standard Test Method for Strength Properties of Tissue Adhesives in Tension (ASTM F 2258-05)
TEST SERVICE
Test Service
KMTL provides a wide range of testing services including fatigue and creep testing to support safety and security for society at large.