DIN EN ISO 14801 outlines a dynamic test method ideally suited for comparing endosseous dental implant systems of varying designs and sizes. We offer standardized testing for fully metallic systems, as well as testing in isotonic saline solution for non-metallic components.
Our eight independent test stations (DORA 14801) ensure efficient, precise execution of every test phaseโfrom preparation and dynamic fatigue testing to the delivery of a comprehensive test report. Rely on our expertise to help bring your products safely and successfully to approval by your notified body in your target market.
A dynamic fatigue test in accordance with DIN EN ISO 14801 provides you with decisive advantages and strengthens the market position of your products.
- A dynamic fatigue test in accordance with DIN EN ISO 14801 simulates extreme conditions for your implant system and verifies if your product can withstand long-term loads.
- They minimize the risk of product and application errors, thereby increasing patient safety.
- The results from the fatigue test provide valuable insights for optimizing your product designs and material selection.
- You can identify weak points early on and implement targeted improvements.
- In order for an implant system to be approved, the relevant authorities require testing in accordance with DIN EN ISO 14801.
- Testing in accordance with DIN EN ISO 14801 is a key component in documenting the safety and performance of your products.
- DIN EN ISO 14801 is internationally recognized (e.g. FDA). A valid test certificate facilitates market launch in almost all countries and regions.
- Companies that subject their products to rigorous testing and validation are perceived as responsible, high-quality suppliers.
- This is what sets them apart from competitors who probably do not have these product tests performed.
- Documented test results provide a solid basis for minimizing risk in the event of complaints or legal issues.
- They protect your company from costly recalls or damaged reputation.
Standard test
Test systems according to DIN EN ISO 14801
The standard tests performed by medpro analytics are in line with DIN EN ISO 14801 to ensure a reliable assessment of your implant system. Based on the specific geometry of your implants and components, we prepare the test sample โ from 3D design to the manufacture of embedding sleeves and test caps.
An optional shear test involving at least four test samples permits the determination of the initial load for the dynamic test. Subsequently, we perform dynamic fatigue tests in accordance with standard specifications at a frequency of 15 Hz in room conditions.
The test setup is precisely customized to your specific requirements (e.g., load direction), ensuring accurate and relevant results. Our comprehensive test reportโincluding detailed photographic documentationโcaptures all findings and serves as a solid foundation for the next steps in your production or approval process. Rely on our expertise to validate the quality and safety of your implant systems.
Dynamic fatigue tests for endosseous dental implants in accordance with DIN EN ISO 14801 require a special test setup for systems with non-metallic components. The tests are performed in isotonic saline solution at a temperature of 37 ยฐC and a frequency of 2 Hz. In this case, respectively, we also prepare a comprehensive test report documenting all results and supplementing them with detailed photographic documentary evidence.
- Construction of the test sample in accordance with standard specifications
- Optional shear test
- Dynamic fatigue test
- Preparation of a test report including photographic documentation
- Further analyses of test samples (SEM), if required