Mechanical Testing Of Medical Devices
SZUTEST provides services with experienced personnel for many years as Notified Body in 93/42/EEC Medical Devices Regulation. Mechanical testing laboratory service is one the most efficient and reliable fields of our activities.
SZUTEST services include static and fatigue testing according to ASTM standards or following your custom testing procedures especially for implants, prosthesis and sterilization packs. Our laboratory is accredited in the scope of EN ISO/IEC 17025 in Medical Devices area. We are using high quality and precise testing equipment, well known in the market (Instron-England, Shimadzu-Japan).
Our customers benefit from more than 5 years of experience in implant testing.
- Spinal Stabilization System (Static compression bending and Fatigue tests for various spinal systems)
- Screws (Pullout and Torsion tests for all types of screws)
- Rods (Static and Fatigue tests for rods used in spinal systems)
- Cages (Static compression and Fatigue tests for all types of Servical and Lumbar cages)
- Packaging seal (Tensile tests for sterilization bags)
- Thin plastic sheeting (Tensile tests for all types of thin packaging sheeting)
Accreditation is the only tool for securing the acceptability of your test reports. Accredited test reports will be required by your clients , by the authorities and by conformity assesment companies.
Accredited laboratories shall be a part of laboratory proficiency programs and shall validate their results.
Szutest is accredited by International Accreditation Service (IAS). You may reach our accreditation certificate by clicking here
- ASTM F382:Standard Specification and Test Method for Metallic Bone Plates
- ASTM F384:Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- ASTM F543:Specification and Test Methods for Metallic Medical Bone Screws.
- ASTM F1717:Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- ASTM F2077:Test Methods For Intervertebral Body Fusion Devices.
- ASTM F2193:Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
- ASTM F1798:Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM D882:Standard Test Method for Tensile Properties of Thin Plastic Sheeting
- ASTM F88:Standard Test Method for Seal Strength of Flexible Barrier Materials