11.060.15 - Dental implants
ICS 11.060.15 Details
Dental implants
Dentalimplantate
Implants dentaires
Zobni implantati
General Information
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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.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft9 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft9 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
ISO 19023:2018 specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment.
ISO 19023:2018 gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information.
NOTE Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic treatment and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements, and test methods for artificial teeth such as
ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 this International 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 dental prosthesis, particularly if multiple endosseous dental implants are used for a dental prosthesis.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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, Dentistry — Designation system for teeth and areas of the oral cavity. 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 5-8 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.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard16 pagesEnglish languagesale 15% off
- Standard16 pagesEnglish languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
This International Standard 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, Dentistry — Designation system for teeth and areas of the oral cavity. 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 5-8 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.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical report7 pagesEnglish languagesale 15% off
- Technical report7 pagesEnglish languagesale 15% off
- Technical report7 pagesFrench languagesale 15% off
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.
- Standard2 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
EN ISO 16443 specifies terms and definitions for dental implants and for instruments, accessories, and the most commonly used clinical terms related to implant systems and procedures in dentistry. Grafting materials and membranes are excluded from this International Standard. The following devices are also excluded from the scope of this International Standard. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an epithesis (to replace for example: ears, noses and parts of eyes and orbital regions): - epithesis implant; - craniofacial implant; - maxillofacial implant. Device specially designed to be placed within, through or upon the bones of the cranio-facial complex, the primary purpose of which is to provide anchorage for an orthodontic appliance: - orthodontic implant.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft25 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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). This information will be recorded by the responsible clinician in the patient’s file and should be made available to the patient by the clinician(s) who provided the care.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard5 pagesEnglish languagesale 15% off
- Standard5 pagesFrench languagesale 15% off
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical specification7 pagesEnglish languagesale 15% off
- Technical specification7 pagesFrench languagesale 15% off
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.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
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 dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technical file.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
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.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
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.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 (> 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. Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
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.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
This standard applies to membrane materials, whether resorbable, partially resorbable or non-resorbable, used - for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality; - in contact with teeth, - for prevention of epithelial migration in periodontal surgery; - in conjunction with dental implants; - and/or for augmentation of bone for stabilisation of dentures. This standard is not applicable to the following materials: materials the primary intended use of which is to deliver a medicinal product, autografts and allografts or materials intended to act through pharmacological, immunological or metabolic means.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard7 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
This document defines terms for the parts of an implant body that are used in oral implantology as well
as the designation and determination of the dimensions and their data on the packaging of an oral
implant.
Four general terms for diameter (endosteal diameter, platform diameter) and length (endosteal length,
overall length) are defined and explained in examples.
- Draft14 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines terms for the parts of an implant body that are used in oral implantology as well
as the designation and determination of the dimensions and their data on the packaging of an oral
implant.
Four general terms for diameter (endosteal diameter, platform diameter) and length (endosteal length,
overall length) are defined and explained in examples.
- Draft14 pagesEnglish languagesale 10% offe-Library read for1 day
2013-09-19 EMA: Draft for //ENQ received in ISO/CS (see notification of 2013-09-18 in dataservice).
- Amendment13 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 13017:2012 specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of crowns and bridges, removable partial dentures, overdentures, superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 27020:2010 is applicable to brackets and tubes for use in fixed orthodontic appliances.
ISO 27020:2010 gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 this International Standard simulates the functional loading of an endosseous dental implant body and its premanufactured prosthetic components under "worst case" conditions, it is not applicable for predicting the in vivo performance of anendosseous dental implant or prosthesis, particularly if more than one implant is used for a prosthesis.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical specification7 pagesEnglish languagesale 15% off
- Technical specification7 pagesEnglish languagesale 15% off
- Technical specification7 pagesFrench languagesale 15% off
This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard 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 ( 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. Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641.
This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
Migrated from Progress Sheet (TC Comment) (2000-07-10): Will be a CR ++ VA/ISO removed (CC/010808) ++ Might be re-registered under VA/ISO but problem with the deliverable! (NT/030206). ++ Wrongly registered as a CR --> deliverable changed further to info from CEN/TC Sec and registered under VA/ISO with ISO/AWI 22794 (NT/030213).
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard9 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
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.
- Technical specification12 pagesEnglish languagesale 15% off
- Technical specification7 pagesEnglish languagesale 15% off
- Technical specification7 pagesFrench languagesale 15% off