Dental implant testing per ISO 14801 uses 疲劳测试 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 疲劳测试
According to ISO 14801, dental implant developers must have an accredited laboratory perform 疲劳测试 to compare endosseous dental implants of different designs 和 sizes. Each implant size 和 shape must be tested to pass regulatory approval, requiring a trusted testing partner who underst和s the unique requirements of dental implant testing. As there are multiple configurations for dental implants, identifying the appropriate test setups 和 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, 然而, im体育APP has the capability to perform static compression test runs on dental implants to assist in determining starting loads for 疲劳测试.
Comprehensive dental implant testing 服务
As a recognized leader in medical device testing, im体育APP has experience performing various tests on dental implants, 包括 metallurgical evaluation 和 失效分析, torque, tension, environmental 和 microbiological analysis. Flexural strength testing is also used to determine the integrity of fixed all-ceramic 和 metal-ceramic dental implants (ISO 6872).
Our trusted medical device experts work diligently to help ensure your success 和 bring a safe product to market. For more information about our dental implant testing or to request a quote, 立即im体育APP.
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