ISO/TC 106/SC 4 - Dental instruments

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 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 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, 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 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 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 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 requirements and their test methods for multiple use of oral surgical scalpel handles used in conjunction with detachable blades for oral surgical procedures such as cutting and/or removal of soft oral tissues. It also specifies the requirements for marking and labelling of oral surgical scalpel handles.

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.

ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1). ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect. ISO 20608:2018 is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the removal of cement residues where abrasion is part of the desired outcome. ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces. ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).

ISO 21533:2018 specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections. ISO 21533:2018 specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging. ISO 14457:2017 is applicable to the following: a) straight and angle handpieces; b) high-speed air turbine handpieces; c) air motors; d) electrical motors; e) prophy handpieces. ISO 14457:2017 is not applicable to the following: - intraoral camera handpieces; - powered polymerization handpieces; - air-powered scalers; - electrical-powered scalers; - powder jet handpieces; - multifunction handpieces (syringes). NOTE See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.

ISO 19490:2017 specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

ISO 1797:2017 specifies the requirements for dimensions and material properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements. ISO 1797:2017 is not applicable to tips fixed to the handpiece with a screw, e.g. scaler tips. Information about the location of marking is also given. Annex A on quality control is included in order to ensure a high quality level.

ISO 7787-3:2017 specifies dimensional and other requirements for the three most commonly used carbide cutters for milling machines which are predominantly used in the dental laboratory. Other characteristics of laboratory cutters (for example, spiralled blades or cross-cut) are not covered by this document. Cutters intended for use with CAD/CAM systems are excluded from the scope of this document.

ISO 19715:2017 specifies requirements and test methods for a filling instrument with contra angle, which is used for the restoration of teeth via the application of polymer-based restorative materials and cements. It also specifies requirements for the design, dimensions and marking.

ISO 3964:2016 specifies the coupling between handpieces and motors connected to dental units. ISO 3964:2016 specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation energy.

ISO 9173-1:2016 specifies the general performance requirements for extraction forceps used in dentistry.

ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. ISO 17509:2016 does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.

ISO 2157:2016 specifies the nominal diameters of the working parts of dental rotary instruments, for example burs, laboratory burs, grinding instruments, diamond instruments, mandrels and the corresponding designation. Excluded are the diameters of endodontic instruments and scaler tips.

ISO 7787-1:2016 specifies dimensional and other requirements for the nine most commonly used steel cutters which are predominantly used in the dental laboratory. Other characteristics of laboratory cutters, for example, spiralled blades or cross-cut, are not covered by this part of ISO 7787. NOTE These cutters are also used in podiatry.

ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items. NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials. It also specifies requirements for their marking and labelling.

ISO 18397:2016 specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.

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.

ISO 13397-5:2015 specifies the designs and dimensions for Jacquette scalers.

ISO 16635-2:2014 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.

ISO 11499:2014 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. ISO 11499:2014 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. Labelling requirements are also specified.

ISO 9173-3:2014 specifies the design for extraction forceps used in dentistry.

ISO 3630-2:2013 specifies requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4 or ISO 3630-5. ISO 3630-2:2013 specifies requirements for size, marking, product designation, safety considerations, and their labelling and packaging, including the instructions for use.

ISO 16635-1:2013 specifies requirements and test methods for hole punches for dental rubber dams.

ISO 10323:2013 specifies bore diameters for rotary instruments such as metallic discs and metallic wheels used in dentistry in order to achieve interchangeability between discs and wheels and the mandrels with which the discs and wheels are operated in a dental handpiece.

ISO 21672-2:2012 specifies the designation of periodontal probes.

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

1 Scope This part of ISO 21672 specifies general requirements and test methods for periodontal probes. It is applicable to periodontal probes made of austenitic and martensitic stainless steel. It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.

ISO 7711-2:2011 specifies requirements for diamond discs used commonly in the dental laboratory for the cutting of dental materials, such as metals, ceramics, plastics or gypsum. In addition, ISO 7711-2:2011 selects five specific shapes with their specific dimensions.

ISO 9173‑2:2010 specifies the designation of dental extraction forceps.

ISO 7885:2010 gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques. Only the materials used for the construction of the needle tubing are specified.

ISO 9168:2009 is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces. ISO 9168:2009 specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust.