ISO 14801 Dentistry - Implants - Dynamic Loading Test for Endosseous Dental Implants

The “ISO 14801 Dentistry - Implants - Dynamic loading test for endosseous dental implants” standard, developed by the International Organization for Standardization (ISO) , describes a dynamic testing method for single-post endosseous dental implants of the transmucosal type, together with prefabricated prosthetic components.

This method is most useful for comparing endosseous dental implants of different designs or sizes. This international standard is not a test of the fundamental fatigue properties of the materials from which endosseous implants and prosthetic components are made. Furthermore, this standard is not applicable to dental implants or magnetic attachments with endosseous lengths shorter than 8 mm.

While this standard simulates the functional loading of an endosseous dental implant under worst-case conditions, it is not applicable for predicting the in vivo performance of an endosseous dental implant or denture, particularly if more than one endosseous dental implant is used for a denture.

For the purposes of this standard, the following terms and definitions apply:

• Endosseous dental implant system refers to a device consisting of integrated components, including auxiliary tools and specialized equipment necessary for clinical and laboratory preparation and placement of the implant and for the fabrication and placement of the dependent denture. In addition to providing resistance to displacement of an implant superstructure, an endosseous dental implant can be used as an anchor for orthodontic appliances. An endosseous dental implant may consist of one or more components. The term implant superstructure includes crowns and fixed and removable prostheses, but excludes implant abutments.
• Prosthetic components refer to implant components to be used for a two-piece implant or a multi-piece implant. Implant abutments, dental implant connectors, abutment screws, and implant connector screws are used as prosthetic components in this standard.
• Endoseous dental implant assembly refers to the dental implant assembly for endoseous dental implant.
• Load cycle diagram refers to the diagram that summarizes the dynamic loading characteristics of an endosseous dental implant by showing the number of cycles each specimen endures at failure for each value of applied peak load.
• Endoseous dental implant body refers to the implant body of the endoseous dental implant.

In principle, testing should be performed on samples representative of the finished device (i.e. implant components that have undergone the same manufacturing process and sterilization as the device to be marketed). If the manufacturer intends the endosseous dental implant to be sterilized by the clinician prior to surgery, sterilization should be performed prior to testing as specified in the manufacturer's instructions for use. However, if there is evidence that the specified sterilization method does not have a significant effect on the properties of all materials in the tested samples, sterilization prior to testing is not required.

A multi-piece endosseous dental implant should be tested assembled according to its intended use. An endosseous dental implant component recommended by the manufacturer for use with components from another manufacturer should be tested assembled according to the manufacturer's statement. When a multi-piece device is assembled using screw connections, these should be used according to the manufacturer's recommendations and tightened to the manufacturer's recommended torque using the equipment provided with the implant system (implant screwdriver, torque wrench) or, if the original tools are not available, a device that provides torque within plus/minus 5 percent of the recommended value. The tightening sequence should be as recommended by the manufacturer.

If a component of an endosseous dental implant system is available in a variety of sizes or configurations, testing for worst-case conditions within the proposed use should be performed. The worst-case selection should be justified and documented. Guidance on how to select the worst-case is included in the standard appendix (Appendix B).

Among the numerous tests, measurements, analyses and evaluation studies that our organization has carried out for businesses in various sectors, it also provides testing services defined in the “ISO 14801 Dentistry - Implants - Dynamic loading testing for endosseous dental implants” standard with its trained and expert staff and advanced technological equipment.