ISO 14801 is an industry standard test method that regulatory agencies use to establish minimum performance standards for dental implants.
If you plan on conducting ISO 14801 we recommend acquiring the test standard from ISO. There are many important details regarding this test method that are provided which are key to achieving successful results. Every standard provides important environmental conditions, test sample preparation and conditioning requirements, sample dimensions and test reporting expectations. It’s critical that you fully understand the standard so that you can set up the test, run the procedure, and report the results requirements.
What Is ISO 14801?
Dental implants have become a popular, permanent replacement for missing teeth. They are inserted into the jawbone and, over time, fuse with the bone. Dental implants will sometimes experience rare mechanical failures such as fractures. Most of the time, these are caused by time-dependent metal fatigue. ISO standards ensure the longevity of the implant.
The implant is tested under what is deemed to be the worst case conditions experienced by the implant. Those conditions include tilting the implant by a certain angle, usually 30°, with respect to its longitudinal axis, in order to induce bending stresses representative of the implant’s inclination in the oral cavity. Moreover, part of the thread may be left outside of the basal grip to mimic bone loss, therefore adding an additional lever that increases the total bending moment.
What Other Resources Focus on Dental Fatigue Applications?
- Dental Fatigue Testing With the Orthogonal Mastication Stage
- Accelerated Fatigue Life Tests (SSALT) of Dental Implants
- Fatigue of dental implants - facts and fallacies - NIH
- Mechanical Evaluation of Four Narrow Diameter Implant Systems - by Dr. Paulo Cuelo
Important Considerations When Testing per ISO 14801
Caution shall be taken when using the results for design as they are generally not indicative of the true fatigue properties of the material in this application. ISO 14801 tests do not represent true worst case applications. Researchers report multiple scenarios that support the need for higher test loads and random spectrum loading conditions at speeds to 3 Hz. ISO 14801 is designed to validate and to compare how implants perform relative to each other.
ISO 14801 Test Method
First, a shear failure test is performed to establish maximum static load.That establishes the baseline fatigue test requirement. Each test specimen is cyclically loaded at a 30° angle from the longitudinal axis. Loading is sinusoidal at a frequency of 15 Hz or less (≤ 15 Hz). The test goal is to determine the endurance or fatigue properties of endosseous dental implants when subjected to dynamic loading. Tests are carried out from 2 to 15Hz and impart a bending fatigue onto the implant after potting or insertion into an appropriate test sample holder.
Test multiple samples to generate S-N endurance curves. Runout can vary depending on the frequency of the test, and range from 2,000,000 (2 Hz) to 5,000,000 (15 Hz) cycles. Testing in saline or a constant fluid temperature bath of 37°C (98.6°F) is desired in addition to ambient testing of 20°C (68°F). When testing in a bath, the maximum frequency is 2 Hz.
Test data requirements include capturing loads applied, number of cycles performed (duration), and loading frequency.
Dynamic Test Machines for ISO 14801
Our 800 series of fatigue test machines are ideal for these dental implant fatigue test applications.
The lower priced 840E2 test machines are capable of performing fatigue tests at speeds up to 15 Hz with load capacities of 500 N (112 lbf) and up. The 840 load frame does not accommodate the bath nor the adjustable angle base. Both product families feature servo controlled electric dynamic actuators. They both are capable of precisely controlled loading and fatigue reliability. They both meet the requirements of the standard.
ISO 14801 Test Systems→
Test Fixtures for ISO 14801
GISO14801: A 30° angled base into which the dental implant is screwed. A flat bottom compression probe that is attached to the actuator rod and pushes down onto the implant. An optional probe includes a U-joint distal end which avoids transverse motion at the interface with the hemispherical fixture as required in the standard. .
GISO14801XY: Provides mechanical flexibility such as an adjustable test sample angle with linear slides to allow the sample position to be adjusted in either X or Y dimension. These features are useful when performing research and development of new implants.
Biobath: Saline bath at 37°C
Articles Related to ISO 14801
ISO 14801 Testers
840E2 Low Force Dynamic Test Machines
Most Economical
These systems are compact, lightweight and is the ideal solution for low force fatigue testing. They can perform both dynamic and static testing.
800E2 Mid Force Dynamic Test Machines
Best Performance
Ideal for both dynamic and static testing and is the best solution for mid force fatigue testing.
ISO 14801 Test Fixtures
ISO 14801 Fatigue Test Machine Software
ISO 14801 Test Machine Controller Software | NISO14801
Application specific module features preset settings, test calculations, and graphical test report contents.
Video Recording and Playback Software Module | TestVideo
High resolution video capture of the test. Playback is time synchronized with load data.
