ISO 14801

STEP Lab specialises in the manufacture of testing machines capable of performing a variety of tests in a wide range of applications and industries. All machines are designed in accordance with global standards and regulations, including ISO 14801.

WHAT IS ISO 14801?

ISO 14801 is an International Standard that outlines a method for dynamic testing of single post endosseous dental implants with their premanufactured prosthetic components. Its main purpose is to compare implants of different designs or sizes. However, it does not test the fatigue properties of the materials used in the implants and prosthetic components. The standard does not apply to dental implants shorter than 8mm or those with magnetic attachments. While it simulates the functional loading of an implant under worst-case conditions, it cannot predict the real-life performance of an implant or dental prosthesis, especially when multiple implants are used.

ISO 14801 – GENERAL PRINCIPLES

The testing should be conducted on specimens that represent the complete device and have undergone the same manufacturing process and sterilization as the marketed device. If the manufacturer instructs clinicians to sterilize the implant before surgery, the sterilization process should be carried out according to the manufacturer’s instructions before testing. However, if it can be demonstrated that sterilization does not significantly affect the properties of the tested materials, sterilization prior to testing may not be necessary.

In the case of multi-part dental implants, the testing should be performed on the assembled implant according to its intended use. If a component from one manufacturer is recommended for use with components from another manufacturer, the testing should be conducted with the components assembled as recommended by the recommending manufacturer. When screw joints are used to assemble the device, they should be tightened according to the manufacturer’s recommendations using the provided equipment or a device that provides torque within ±5% of the recommended value. The manufacturer’s recommended tightening sequence should be followed.

If different dimensions or configurations of a component are available within the dental implant system, testing should be conducted under the worst-case conditions within the recommended use. The selection of the worst-case scenario should be justified and documented, and additional guidance on choosing the worst case is provided in Annex B.

ISO 14801 – TEST SYSTEM CHARACTERISTICS

The testing system used for the dynamic testing of dental implants must meet several requirements. It should be able to apply the specified load with an error margin no greater than ±5% at the maximum load, following the guidelines of ISO 7500-1. The machine should also have the capability to apply the load at the prescribed frequency. Additionally, it should be equipped with instrumentation to monitor the maximum and minimum loads, loading frequency, and detect any failure of the specimen during the test. Lastly, the machine should have the ability to record the number of loading cycles performed during the test.