SpineServ Tests Pen Injectors and Bone Screws in Accordance with International Standards
Case Study
- Customer: SpineServ GmbH & Co. KG
- Location: Ulm, Germany
- Industry: Medical, contract testing
- Topic: Tests on medical devices, in particular: ISO 11608-1, tests on needle-based injection systems and ASTM F534, tests on bone screws
SpineServ: leading testing laboratory for medical products and combination products
SpineServ GmbH & Co. KG is a DIN EN ISO/IEC 17025 accredited testing laboratory specializing in the mechanical testing of surgical implants, medical devices and combination products. Since its foundation in 2007 as a spin-off from the University of Ulm, SpineServ has established itself as a reliable partner for developers, manufacturers and distributors of medical devices.
Customers benefit from comprehensive expertise and state-of-the-art laboratories in which mechanical tests are carried out on medical devices—both during development and as part of the approval process for the European, US and international markets. All relevant regulations and standards are taken into account to ensure the safety and effectiveness of the products.
A particular focus is on the testing of complex combination products that include both medicinal products and medical devices, such as prefilled pen injectors. These tests play a key role in ensuring that customers receive the necessary market approvals and can bring their products to market safely and effectively. With an interdisciplinary team of experts and a network of highly qualified cooperation partners, SpineServ offers customized solutions for the specific requirements of each project. Services include static and dynamic testing, test plan preparation, (design) validation and verification as well as aging and preconditioning. Through their commitment to quality, safety and innovation, SpineServ helps customers achieve their goals and make a positive contribution to healthcare worldwide.
Precision testing for bone screws and pen injectors
Challenge:
Testing bone screws and pen injectors requires high precision and versatility of the testing machines. The torsional moment must be precisely controlled under a defined axial force, particularly in screw-in/screw-out tests on bone screws. Tests on pen injectors include both tensile and compressive loads. Both product types require the application of very low torques and forces. In addition, all testing processes must comply with the regulatory requirements of the target markets, including CE marking in the EU and FDA regulations in the USA.
Solution:
SpineServ uses an axial-torsional zwickiLine testing machine to simulate the specific performance requirements and loading scenarios for bone screws and pen injectors. Typical test methods on bone screws include torsion tests, screw-in/screw-out tests and pull-out tests. For pen injectors, tests are carried out that include the screwing in or unscrewing of components as well as tensile and compressive loads. The versatility of the testing machine makes it possible to meet the different requirements of both product types.
The testing process at SpineServ is closely tied to the regulatory requirements of the target markets. This includes the traceability of the results, their counterfeit protection and the qualification and validation of the entire system. By complying with these strict specifications, SpineServ contributes to the safety and effectiveness of the tested medical devices and supports customers in achieving market approval.
