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
This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify, define the geometric characteristics, and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates
ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.
ASTM F543: Specification and Test Methods for Metallic Medical Bone Screws
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification
ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific depending on the intended spinal location and intended method of application to the spine
ASTM F2077:Test Methods For Intervertebral Body Fusion Devices.
This test method describes the materials and methods for testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. Depending on the intended spinal location, the devices are tested in static and dynamic axial compression, shear compression and/or torsion mode. For testing, the implants are inserted between polyacetal test blocks for dynamic loading or stainless steel blocks for static loading
ASTM F2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
Specifications and test methods for metallic spinal screws, metallic spinal plates and metallic spinal rods is given within ASTM F2193 Test standard
ASTM F1798: Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants
The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs.
ASTM F88: is the standard followed when performing Peel tests on Packaging. Peel Tests determine ‘Seal strength’ of the package, which is defined as the measure of the ability of a package seal to resist separation. The test results are not only related to package integrity, but also to measuring the packaging processes’ ability to produce consistent seals.
Services provided by SZUTEST for medical devices are as follows: