ISO/TC 106 - Dentistry

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.

This document specifies test methods for machinable ceramic blanks used for the fabrication of dental fixed restorations. This document also specifies the contents of the test report.

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.

This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging. This document applies to operating lights, irrespective of the technology of the light source. This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.

This document specifies the general requirements and test methods for diamond rotary instruments used in dentistry, including designation, colour code and grit sizes and a quality control for these instruments. It applies to all types of diamond rotary instruments independent of type and shape with exception to diamond discs, which are specified in ISO 7711-2.

This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table 3). Clause 7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.

This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam. This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form. This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration. This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount required to make a small to medium-sized restoration in a single tooth. This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.

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.

This document specifies the requirements and test methods for endodontic compactors (pluggers and spreaders) which are used for the compaction of endodontic filling materials, and also heat-carriers (which are not specified in the other parts of the ISO 3630 series). This document specifies the requirements for size, marking, product designation, safety considerations, and their labelling and packaging.

This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures, such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

This document specifies dimensions and performance requirements for excavators used in dentistry.

This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) dental microscopes for minimally invasive treatments; d) medical endoscopes; e) camera handpieces for tooth illumination (transillumination); f) CAD or CAM scanner handpieces; g) combinations of dental instruments with camera functions; h) cameras for endodontic purposes; i) devices for root canal inspection (endoscopic microcameras); j) cameras for tool navigation; k) cameras for determination of tooth colour.

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.

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements. This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.

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.

This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements. This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.

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.

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator's stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

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.

This document specifies test methods and procedures to determine the corrosion behaviour of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual International Standards specifying such metallic materials. This document is not applicable to dental instruments.

This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

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.

This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.

This document specifies the requirements for the permissible reduction in strength resulting from crevice corrosion of dental amalgam products that are within the scope of ISO 24234 or ISO 20749. It provides details of the test procedure for determining this.

This document specifies requirements and test methods for central compressed air source equipment supplying dental air for dental units and various dental air consuming devices in the dental office. It also specifies quality requirements and test methods for the dental air produced by the central compressed air source equipment, such as requirements for the purity level of dental air. It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central compressed air source equipment. This document applies only to central compressed air source equipment located outside of the dental treatment room. This document does not apply to central compressed air source equipment located in the dental treatment room and facility piping. This document does not include requirements for dental laboratory applications (e.g. CAD/CAM systems).

This document specifies requirements, test methods, instructions for use and marking for multifunction handpieces (colloquially called "syringes") intended to be used in the oral cavity of the patient. This document does not apply to dental handpieces and motors, intraoral cameras, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas and saliva ejectors.

This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system. This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel. It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.

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.

This document gives the details of test procedures for evaluating the corrosion resistance of dental amalgam formed from products that are within the scopes of ISO 24234 and ISO 20749. This document is not applicable to other metallic materials in which an alloy powder reacts with a liquid alloy to produce a solid metallic material intended for dental restoration.

This document specifies dimensional and other requirements for the 11 most commonly used carbide cutters which are predominantly used in the dental laboratory. NOTE These cutters are also used in podiatry.

This document specifies general requirements and test methods for metallic dental tweezers of the Meriam type and for College type. This document is not applicable to anatomical tweezers and surgical tweezers.

This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures. It specifies shapes and dimensions as well as information for marking.

This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics. This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure. This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

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.

This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

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.

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.

This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting. The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506). The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requirements for metallic casing and metallic handles are given.

This document specifies the dimensions and performance requirements for dental explorers. This document is not applicable to endodontic explorers.

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.

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.

This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment. This document is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added. This document excludes specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.

This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.