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.

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The purpose of this standard is to develop uniform nomenclature for the description of forensic dental data
and define a standardized set of uniform terms to convey this information. The goal of the standard is not to
define the extent of information collected, only to be certain that common terms are used in order to aid in an
identifying human remains or a living amnesiac.

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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.

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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. It also specifies packaging and
labelling requirements, including the instructions for use. This document covers fluoride varnishes to
be applied by dental health care workers.

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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.

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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.

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This International Standard describes 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 shade guides (colour rings) in this standard.
The coordinates of tooth colours in the colour space (colour coordinates) the specification of which is left
to the manufacturers’ discretion as well as the colour deviations of ceramic and other masses or materials
used in the manufacture of dental prosthesis do not fall into the scope of this standard.
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 International Standard.
They can be manufactured from any materials and serve solely to illustrate the colour effect; they do not
serve colour determination inside the mouth.

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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.

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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.

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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.
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 might get detached from the brush shaft.
This document is not applicable to other types of powered oral hygiene devices (such as powered
interdental brushes) or manual toothbrushes.

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This standard describes test methods used to evaluate the repeatability, reproducibility and accuracy of dental devices for 3D metrology. The standard is applicable to dental chairside CAD/CAM systems. The scope of this document is not intended to include unique systems with other specific applications of 3D metrology in the dental field such as 3D computed tomography, magnetic resonance imaging and stereophotogrammetry.

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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.

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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.

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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.

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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.

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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.

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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.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental
case data and CAD/CAM data between software systems.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

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This document specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling
and packaging of dentifrices.
This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological
hazards are not included in this document. These are covered in ISO 7405[1] and ISO 10993-1[2].

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ISO/TR 18845:2017 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, e.g. inlays, crowns and bridges.

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ISO 13078-2:2016 determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic.
The test method is suitable for powdered dental ceramics according to ISO 6872, Type I.
The test method enables monitoring of the temperature control in the dental furnace by evaluating the firing degree of a dental ceramic. The test method is also suitable for evaluating the reproducibility of the firings in a dental furnace or for comparing several dental furnaces.

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ISO 13078-2:2016 determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic. The test method is suitable for powdered dental ceramics according to ISO 6872, Type I. The test method enables monitoring of the temperature control in the dental furnace by evaluating the firing degree of a dental ceramic. The test method is also suitable for evaluating the reproducibility of the firings in a dental furnace or for comparing several dental furnaces.

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This International Standard specifies terms, synonyms for terms and definitions used in the process chain for CAD/CAM systems in dentistry.

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This International Standard provides a system for designating teeth or areas of the oral cavity using
two digits.

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ISO 3950:2016 provides a system for designating teeth or areas of the oral cavity using two digits.

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ISO 18739:2016 specifies terms, synonyms for terms and definitions used in the process chain for CAD/CAM systems in dentistry.

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ISO 3950:2016 provides a system for designating teeth or areas of the oral cavity using two digits.

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ISO 18739:2016 specifies terms, synonyms for terms and definitions used in the process chain for CAD/CAM systems in dentistry.

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This International Standard specifies physical and chemical requirements and test methods for oral
rinses. It also specifies the accompanying information such as the manufacturer’s instructions for use,
marking, and/or labelling requirements.
This International Standard is not applicable to other delivery systems (e.g. mouthsprays, foams,
powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This International Standard is not applicable to oral rinses available by prescription only.

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ISO 17937:2015 specifies requirements and their test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.

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ISO 17937:2015 specifies requirements and their test methods for osteotomes used in dentistry for bone compaction, internal sinus floor elevation, and jaw bone cleaving. It also specifies the requirements for their marking and labelling.

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ISO 16408:2015 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as the manufacturer's instructions for use, marking, and/or labelling requirements.
ISO 16408:2015 is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
ISO 16408:2015 is not applicable to oral rinses available by prescription only.

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This International Standard specifies test methods for the assessment of the accuracy of digitizing
devices for computer-aided design/computer-aided manufacturing (CAD/CAM) systems for indirect
dental restorations. The methods described in this International Standard require a digitizing device in
which the object is mounted relative to the optical or mechanical-contact system and therefore do not
apply to hand-held scanning devices.
These test methods are not applicable to digitization by radiographic (X-ray) methods or by magnetic
resonance imaging (MRI) methods.

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ISO 12836:2015 specifies test methods for the assessment of the accuracy of digitizing devices for computer-aided design/computer-aided manufacturing (CAD/CAM) systems for indirect dental restorations. The methods described in ISO 12836:2015 require a digitizing device in which the object is mounted relative to the optical or mechanical-contact system and therefore do not apply to hand-held scanning devices.
These test methods are not applicable to digitization by radiographic (X-ray) methods or by magnetic resonance imaging (MRI) methods.

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ISO 12836:2015 specifies test methods for the assessment of the accuracy of digitizing devices for computer-aided design/computer-aided manufacturing (CAD/CAM) systems for indirect dental restorations. The methods described in ISO 12836:2015 require a digitizing device in which the object is mounted relative to the optical or mechanical-contact system and therefore do not apply to hand-held scanning devices. These test methods are not applicable to digitization by radiographic (X-ray) methods or by magnetic resonance imaging (MRI) methods.

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EN ISO 11499 gives specific performance requirements for single-use dental cartridges of 1,0 ml, 1.7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics. It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with ISO 9997 and ISO 21533. Labelling requirements are also specified.

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ISO 16443:2014 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 ISO 16443:2014.
The following devices are also excluded from the scope of ISO 16443:2014.
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.

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This International Standard specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models.

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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).

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ISO 29022:2013 specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.

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This International Standard 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 International Standard is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by dental professionals. This International Standard does not specify qualitative or quantitative requirements for freedom from
biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.

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Dental products are marketed for long term, short term and transient use in the mouth. A large number of items have been developed to assist in the treatment and prevention of oral diseases and the handling of dental materials. In contrast to pharmaceuticals (medicinal products), many dental materials are intended to perform as implanted devices in the oral cavity with a minimum of degradation and release of substances, i.e. their main action is to replace lost and defective teeth and oral tissue. Some materials contain elements that may initiate toxic or allergic responses. Other materials have additions of medicinal substances. Many dental materials, instruments, equipment and disposables are covered by the Council Directive 93/42 EEC of 14 June 1993 concerning medical devices. The Directive also provides rules for the classification of medical devices based on risk and intended use. It is the manufacturer's responsibility to classify the product according to the rules of the Directive. The classification should be acceptable to Notified Bodies (NB) and Competent Authorities (CA). The Directive describes procedures for resolving any disputes over classification between manufacturers, Notified Bodies and Competent Authorities.

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This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.

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ISO 21531:2009 presents a series of graphical symbols for dental instruments. They are set out particularly for this area of dentistry or corresponding specific areas within dentistry. General symbols are taken from relevant ISO, IEC or other international documents. Several new symbols presented by manufacturers or users have been added.

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ISO 21531:2009 presents a series of graphical symbols for dental instruments. They are set out particularly for this area of dentistry or corresponding specific areas within dentistry. General symbols are taken from relevant ISO, IEC or other international documents. Several new symbols presented by manufacturers or users have been added.

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ISO 16059:2007 defines the elements of syntax, including the structure and associated content, for the purpose of coded data exchange and the need for harmonizing existing and future dentistry codification documents.

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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.

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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.

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