Dental implant testing per ISO 14801 uses fatigue testing to ensure the integrity of the implant, simulating a worst case condition. Our medical device experts can provide you with the dental implant tests necessary for regulatory submission.
ISO 14801 for dental implant fatigue testing
According to ISO 14801, dental implant developers must have an accredited laboratory perform fatigue testing to compare endosseous dental implants of different designs and sizes. Each implant size and shape must be tested to pass regulatory approval, requiring a trusted testing partner who understands the unique requirements of dental implant testing. As there are multiple configurations for dental implants, identifying the appropriate test setups and predicate information for comparison is critical.
Fatigue tests are performed on the dental implant to create a life-cycle curve. This data allows us to determine the useful-life of the implant. The curve is created by performing 2-3 test runs at a series of load levels (typically 4-5), until a lower limit is reached at which at least three specimens reach 5 million cycles (2 million if performed in-vitro) without failure. Fatigue testing is typically performed at 10Hz (2Hz if performed in-vitro).
ISO 14801 does not outline static testing, however, Element has the capability to perform static compression test runs on dental implants to assist in determining starting loads for fatigue testing.
Comprehensive dental implant testing services
As a recognized leader in medical device testing, Element has experience performing various tests on dental implants, including metallurgical evaluation and failure analysis, torque, tension, environmental and microbiological analysis. Flexural strength testing is also used to determine the integrity of fixed all-ceramic and metal-ceramic dental implants (ISO 6872).
Our trusted medical device experts work diligently to help ensure your success and bring a safe product to market. For more information about our dental implant testing or to request a quote, contact us today.
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