TESTING OF BIOMEDICAL MATERIALS AND PRODUCTS

Medical device testing is essential to turn an innovative project into a reliable and marketable product. We offer advanced solutions for mechanical and technological testing in the medical and pharmaceutical sectors. To set up your laboratory efficiently, we offer flexible and modular systems, including machines, testing devices and software.

We combine expertise in testing products such as prostheses to provide a complete solution. Our testing facilities ensure a thorough evaluation of your products, helping you to demonstrate compliance with global standards and regulations.

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TESTS

DENTAL INDUSTRY

Testing of materials (ceramics and metals), composites, and adhesive bands to determine fatigue resistance on dental implants.

BIOMECHANICS AND ORTHOPAEDICS

We carry out tests on prostheses to verify functions and structures of the musculoskeletal system and movements of biological systems.

MEDICAL PACKAGING

Testing of medical and pharmaceutical product packaging to ensure product safety over an extended storage period.

A significant element of process validation in the medical and pharmaceutical industries is the technical review of individual implants and devices. This qualification also applies to STEP Lab dynamic test systems used in these sectors, which are subject to various legal requirements (e.g. Medical Device Directive 93/42/EEC or regulations such as FDA 21 CFR Part 11 and EU GMP Guideline All. 11). STEP Lab supports its customers in the qualification DQ, IQ and OQ for material testing systems, providing comprehensive and customised documentation in accordance with GAMP5 and current guidelines, and carrying out the actual qualification procedure on site.

Test Center, the only test management software
Test systems developed to operate independently or in collaboration with others
A team of specialists always available
Customised design according to customer needs
Easy to install and manage products
Zero CO2 emissions

Biomedical Industry Standards

ASTM

NORMA	DESCRIPTION
ASTM F1264	Standard Specifications and Test Methods for Intramedullary Fixation Devices
ASTM F1717	Standard test methods for spinal implant structures in a vertebrectomy model
ASTM F1798	Standard test method for the evaluation of static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants
ASTM F1800	Standard Practice for Cyclic Fatigue Testing of Metal Components of the Tibial Plateau of Total Knee Joint Prostheses
ASTM F2068	Standard specifications for femoral prostheses – metal implants
ASTM F2077	Test methods for intervertebral body fusion devices
ASTM F2193	Standard specifications and test methods for components used in surgical fixation of the spinal skeletal system
ASTM F2502	Standard specifications and test methods for resorbable plates and screws for internal fixation implants
ASTM F2580	Standard practice for evaluating the modular connection of a proximally fixed femoral hip prosthesis
ASTM F2706	Standard test methods for occipito-cervical and occipito-cervical-thoracic spinal implant constructions in a vertebrectomy model
ASTM F382	Standard Specifications and Test Method for Metal Bone Plates
ASTM F384	Standard specifications and test methods for angled metal devices for orthopaedic fracture fixation
ASTM F543	Standard Specifications and Test Methods for Metal Medical Bone Screws

ISO

NORMA	DESCRIPTION
EN 843-1	Mechanical properties of monolithic ceramics at room temperature – Determination of flexural strength
ISO 11405	Tooth structure adhesion test
ISO 12189-8	Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using anterior support
ISO 14801	Dentistry – Implants – Dynamic load test for endosseous dental implants
ISO 14879-1	Total knee joint replacement Determining the strength properties of tibial knee trays
ISO 6872	Dentistry – Ceramic materials
ISO 7206	Surgical implants – Partial and total hip joint replacements
ISO 9585	Determination of bending strength and stiffness of bone plates