11.060.01 - Dentistry in general
ICS 11.060.01 Details
Dentistry in general
Dentalmedizin im allgemeinen
Art dentaire en général
Zobozdravstvo na splošno
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This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard70 pagesEnglish languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities.
These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or clinical studies
The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types. For example, brush head plate retention can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the filaments end-rounding requirements, this document does not apply to filament types that are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips or spherical cap) or non-synthetic filaments, where applying the end-rounding process is inappropriate or impossible.
This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.
- Technical report23 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.
- Standard13 pagesEnglish languagesale 15% off
- Standard14 pagesFrench languagesale 15% off
This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.
- Technical report23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a method for designating the coding and nomenclature for tooth developmental stages using a single letter and number to facilitate data entry and support interoperability.
The first letter represents the part of the tooth (crown, root and apex), and the number represents the stage of development of the tooth part.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a method for designating the coding and nomenclature for tooth developmental stages using a single letter and number to facilitate data entry and support interoperability.
The first letter represents the part of the tooth (crown, root and apex), and the number represents the stage of development of the tooth part.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.
- Standard12 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a method for designating the coding and nomenclature for tooth developmental stages using a single letter and number to facilitate data entry and support interoperability. The first letter represents the part of the tooth (crown, root and apex), and the number represents the stage of development of the tooth part.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This document establishes a system for classifying the location and depth of human tooth restorations preparations.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes a system for classifying the location and depth of human tooth restorations preparations.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method for the calibration of resistance-heated high temperature sintering furnaces that are suitable for the sintering of dental restorations in the temperature range up to 1 700 °C.
NOTE A test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C is specified in ISO 13078:2013. ISO 13078:2013 does not include the calibration of sintering furnace used for sintering of oxide ceramics or sintered metal, in whose firing chamber restorations are sintered at temperatures of 1 000 °C to 1 700 °C.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the test methods to evaluate the machining accuracy of computer-aided milling machines as a part of dental CAD/CAM systems, which fabricate dental restorations, such as inlays, crowns and bridges.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes a system for classifying the location and depth of human tooth restorations preparations.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
This document specifies the test methods to evaluate the machining accuracy of computer-aided milling machines as a part of dental CAD/CAM systems, which fabricate dental restorations, such as inlays, crowns and bridges.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the test methods to evaluate the machining accuracy of computer-aided milling machines as a part of dental CAD/CAM systems, which fabricate dental restorations, such as inlays, crowns and bridges.
- Standard46 pagesEnglish languagesale 15% off
- Standard49 pagesFrench languagesale 15% off
This document specifies a test method for the calibration of resistance-heated high temperature sintering furnaces that are suitable for the sintering of dental restorations in the temperature range up to 1 700 °C.
NOTE A test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C is specified in ISO 13078:2013. ISO 13078:2013 does not include the calibration of sintering furnace used for sintering of oxide ceramics or sintered metal, in whose firing chamber restorations are sintered at temperatures of 1 000 °C to 1 700 °C.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method for the calibration of resistance-heated high temperature sintering furnaces that are suitable for the sintering of dental restorations in the temperature range up to 1 700 °C. NOTE A test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1 050 °C is specified in ISO 13078:2013. ISO 13078:2013 does not include the calibration of sintering furnace used for sintering of oxide ceramics or sintered metal, in whose firing chamber restorations are sintered at temperatures of 1 000 °C to 1 700 °C.
- Standard6 pagesEnglish languagesale 15% off
- Draft7 pagesFrench languagesale 15% off
This document describes methods of acquiring and analysing data from which the accuracy of a numerical model of the geometry of the mucosa and implant bodies in the jaw of a patient can be assessed.
- Technical report22 pagesEnglish languagesale 15% off
- Technical report22 pagesEnglish languagesale 15% off
- Technical report22 pagesEnglish languagesale 15% off
- Technical report23 pagesFrench languagesale 15% off
- Technical report23 pagesFrench languagesale 15% off
This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.
- Standard4 pagesEnglish languagesale 15% off
This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.
- Standard71 pagesEnglish languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
- Standard73 pagesFrench languagesale 15% off
This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.
This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer.
This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document deals with the methods for measuring the performance of electrically powered toothbrushes.
This document applies to electrically powered toothbrushes used for cleaning the teeth with electric energy to drive. Rechargeable toothbrushes and primary battery powered toothbrushes, both for adult and child, are within the scope of this standard.
This standard is just to specify the measurement method but does not define any limit value.
NOTE: The electrically powered toothbrushes are classified as follows:
Classification with regard to supply modes:
- primary battery powered toothbrush
- rechargeable toothbrush
-- wireless rechargeable toothbrush
-- corded rechargeable toothbrush
Classification with regard to moving modes:
- rotary electrically powered toothbrush
- reciprocated electrically powered toothbrush
-- linear reciprocated electrically powered toothbrush
-- rotational reciprocated electrically powered toothbrush
- vibratory electrically powered toothbrush
The different types are clarified for information, since there is no difference in the tests to be done, except for the types of primary battery powered toothbrush and rechargeable toothbrush.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products.
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the terms used to describe the distinctive characteristics of an individual's mouth by dentists and forensic dental experts. These terms are organized by concepts based on a forensic approach to the characteristics of a mouth, with many concepts specific to the identification domain that are not defined elsewhere in ISO dentistry vocabularies (e.g. "present tooth").
The hierarchical structure of this document is designed to describe attributes of a tooth, the mouth and a prosthesis/orthosis with increasing levels of discriminative characteristics (e.g. material characteristics, restored tooth surface) and the possibility to connect any level of description of an attribute with the most comprehensive concept.
This document is intended to be used for data exchange between antemortem and postmortem files and remove ambiguity on the terms used to describe an individual's mouth.
This document is intended to be used in conjunction with ISO 1942 and ISO 3950.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines terms used in dental product standards.
This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer's instructions for use.
This document is not applicable to tooth bleaching products:
— specified in ISO 11609;
— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;
— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country's regulatory body.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides a nomenclature of oral anomalies and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various anomalies that can be found in the oral cavity. When needed, information on the localization of the anomaly can be added through the use of other codes such as ISO 3950.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides a nomenclature of oral developmental disturbances of teeth and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various developmental disturbances of teeth.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the terms used to describe the distinctive characteristics of an individual's mouth by dentists and forensic dental experts. These terms are organized by concepts based on a forensic approach to the characteristics of a mouth, with many concepts specific to the identification domain that are not defined elsewhere in ISO dentistry vocabularies (e.g. "present tooth").
The hierarchical structure of this document is designed to describe attributes of a tooth, the mouth and a prosthesis/orthosis with increasing levels of discriminative characteristics (e.g. material characteristics, restored tooth surface) and the possibility to connect any level of description of an attribute with the most comprehensive concept.
This document is intended to be used for data exchange between antemortem and postmortem files and remove ambiguity on the terms used to describe an individual's mouth.
This document is intended to be used in conjunction with ISO 1942 and ISO 3950.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines terms used in dental product standards.
This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
This document defines the terms used to describe the distinctive characteristics of an individual's mouth by dentists and forensic dental experts. These terms are organized by concepts based on a forensic approach to the characteristics of a mouth, with many concepts specific to the identification domain that are not defined elsewhere in ISO dentistry vocabularies (e.g. "present tooth"). The hierarchical structure of this document is designed to describe attributes of a tooth, the mouth and a prosthesis/orthosis with increasing levels of discriminative characteristics (e.g. material characteristics, restored tooth surface) and the possibility to connect any level of description of an attribute with the most comprehensive concept. This document is intended to be used for data exchange between antemortem and postmortem files and remove ambiguity on the terms used to describe an individual's mouth. This document is intended to be used in conjunction with ISO 1942 and ISO 3950.
- Standard54 pagesEnglish languagesale 15% off
- Standard56 pagesFrench languagesale 15% off
This document defines terms used in dental product standards. This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization.
- Standard37 pagesEnglish languagesale 15% off
- Standard38 pagesFrench languagesale 15% off
This document specifies requirements for tooth-like colour representations made of ceramic materials used to determine the tooth colour in the patient's mouth or to check the colour of dental prosthesis, which are referred to as colour tabs in this document.
The colour coordinates of colour tabs are left to the manufacturers' discretion.
Resources for visualizing the colours of ceramic and other masses, e.g. mass shade guides and colour patterns for certain ceramic and other masses, do not fall into the scope of this document. They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not serve to determine colour inside the mouth.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides a nomenclature of oral developmental disturbances of teeth and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various developmental disturbances of teeth.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides a nomenclature of oral anomalies and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various anomalies that can be found in the oral cavity. When needed, information on the localization of the anomaly can be added through the use of other codes such as ISO 3950.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and procedures for assessing the accuracy of a three dimensional numerical description of intra-oral surfaces acquired directly from a patient with a hand-held scanning device. The test methods are not applicable to ultrasonic, radiographic or magnetic resonance imaging methods.
NOTE ISO 12836 specifies the test methods for the assessment of accuracy of digitizing devices that use a fixed or a mechanically guided scanning device.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and procedures for assessing the accuracy of a three dimensional numerical description of intra-oral surfaces acquired directly from a patient with a hand-held scanning device. The test methods are not applicable to ultrasonic, radiographic or magnetic resonance imaging methods.
NOTE ISO 12836 specifies the test methods for the assessment of accuracy of digitizing devices that use a fixed or a mechanically guided scanning device.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies test methods and procedures for assessing the accuracy of a three dimensional numerical description of intra-oral surfaces acquired directly from a patient with a hand-held scanning device. The test methods are not applicable to ultrasonic, radiographic or magnetic resonance imaging methods. NOTE ISO 12836 specifies the test methods for the assessment of accuracy of digitizing devices that use a fixed or a mechanically guided scanning device.
- Standard15 pagesEnglish languagesale 15% off
- Standard15 pagesFrench languagesale 15% off
This document provides a nomenclature of oral anomalies and a code for their representation to facilitate data entry and support interoperability at the semantic level. This nomenclature covers the various anomalies that can be found in the oral cavity. When needed, information on the localization of the anomaly can be added through the use of other codes such as ISO 3950.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
This document provides a nomenclature of oral developmental disturbances of teeth and a code for their representation to facilitate data entry and support interoperability at the semantic level. This nomenclature covers the various developmental disturbances of teeth.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document specifies terms, synonyms of terms and definitions used in the process chain from initial implant treatment imaging until the placement of the finished prosthesis. This process chain includes different steps from dental CT to CAD/CAM for implant prosthetic restorations. Some aspects of this process chain are also called backward planning.
- Technical report5 pagesEnglish languagesale 15% off
- Technical report6 pagesFrench languagesale 15% off