ISO/TC 106/SC 8 - Dental implants

This document specifies a test method to evaluate the rotational adaptability between an implant body and an implant abutment in a dental implant system. This document is applicable to the implant systems which do not have a friction-fit between implant body and implant abutment but incorporate only an anti-rotational feature between these components. Analog or replica components cannot be used to evaluate the adaptability of dental implant systems.

ISO 14801:2016 specifies a method of dynamic testing of single post endosseous dental implants of the transmucosal type in combination with their premanufactured prosthetic components. It 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 the endosseous implants and prosthetic components are made. This International Standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments. While ISO 14801:2016 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 dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.

ISO/TR 18130:2016 provides guidelines for a method to determine the extent of screw loosening of the metallic implant body/implant abutment joint of endosseous dental implants, such as two-part implants or multi-part implants under cyclic torsional loading. This test is most appropriate for evaluating new types of joints fixed using screw(s) and metallic connecting parts. This Technical Report provides a protocol for torsional cyclic torque on an implant body/implant abutment joint, but its intended use is for prefabricated implant bodies, implant abutments and, if appropriate, implant connecting parts that are made of metallic materials. It is not applicable to ensure the in vivo performance of endosseous dental implants and is not derived from observations of clinical failures. NOTE This Technical Report is not intended for use with temporary abutments.

ISO 19429:2015 provides a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the system describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5 to 8 which are employed when indicating a primary tooth. This information should be recorded by the responsible clinician in the patient's file and made available to the patient by the clinician(s) who provided the care.

ISO 16498:2013 specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient's jaw(s).

ISO/TS 13498:2011 establishes a method to determine the torsional yield strength and maximum torque of the implant body/connecting part joints of endosseous dental implant systems. This test is most appropriate for evaluating new types of joints and connecting parts, as well as new materials. ISO/TS 13498:2011 provides a protocol for torsional loading of an implant body/connecting part joint. It is not applicable for predicting the in vivo performance of an endosseous dental implant system and it is not derived from observations of clinical failure.

ISO 10451:2010 specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof that remains in the mouth after surgery.

ISO 11953:2010 describes a classification system for hand-held torque wrenches intended for clinical use. It specifies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. Test methods are described, and marking and labelling requirements specified.

ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, b) in contact with teeth and/or dental implants, c) for prevention of epithelial migration in periodontal surgery, d) for the augmentation of bone prior to the planned insertion of dental implants, e) and/or for augmentation of bone for stabilization of dental prostheses. This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

ISO/TS 22911:2016 concerns animal tests relevant to the functional assessment of dental implant systems, using both macroscopic and microscopic parameters. It is intended for use only when risk analysis indicates a need for additional information that only animal testing can provide. ISO/TS 22911:2016 is not intended to provide information on the mechanical strength of implantable materials themselves, but rather a qualitative evaluation of the implant-bone interface.

ISO 14801:2007 specifies a method of fatigue testing of single post endosseous dental implants of the transmucosal type and their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. While it simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under “worst case” conditions, ISO 14801:2007 is not applicable for predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if multiple endosseous dental implants are used for a prosthesis.

ISO/TS 22911:2005 concerns animal tests relevant to the functional assessment of dental implant systems, using both macroscopic and microscopic parameters. It is intended for use only when risk analysis indicates a need for additional information that only animal testing can provide.

ISO 14801:2003 specifies a method of fatigue testing of single-post endosseous dental implants of the transmucosal type. It is most useful for comparing endosseous dental implants of different designs or sizes. While it simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under worst-case conditions, ISO 14801:2003 is not applicable for predicting the in vivo performance of an endosseous dental implant or prosthesis, particularly if multiple endosseous dental implants are used for a prosthesis.

This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated part thereof which remains in the mouth after surgery. This International Standard is not applicable to instruments and other parts specifically made for the implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.

Provides general guidelines, principles and concepts relevant to the production of a given type of dental implant; does not aim to define the ideal dental implant. Includes technical aspects and biological aspects.