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.

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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.

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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.

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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).

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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.

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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.

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2019-01-21: Parallel process missed, so adoption of published ISO

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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 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.

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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).

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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.

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

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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 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.

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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.

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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.

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This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard.
This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

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ISO 20749:2017 specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration.
ISO 20749:2017 specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
ISO 20749:2017 is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.
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.
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993‑1 and ISO 7405.
The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.

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This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered.
This document also specifies requirements for the instructions for use, for the technical description, for marking and for packaging.
Operator's stools, portable dental equipment and operating lights are not in the scope of this document.

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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 and test methods for stationary, electrically powered central suction source equipment, including centrally located amalgam separators and air water separators.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central suction source equipment as part of the complete dental suction system.
This document specifies requirements for central suction source equipment used to provide vacuum pressure and flow at the facility pipeline connection point.
This document does not apply to portable suction source equipment, air/water venturi suction source equipment, or to suction source equipment located in the treatment room. It also does not apply to suction source equipment used for life support or for scavenging halogenated anaesthetic gases.
This document does not include requirements for facility and exhaust piping systems or treatment room equipment.

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MINOR REVISION

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ISO 28319:2018 specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances.
For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.

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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).

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ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam.
ISO 7488:2018 specifies the test methods used to determine conformity with these requirements.
ISO 7488:2018 refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product.
ISO 7488:2018 does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.

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ISO 9687:2015 specifies graphical symbols for dental equipment. It is intended that the symbols are to be used on the appropriate piece of dental equipment and in documents pertaining to dental equipment, for example in instructions for use, marking, labelling, and technical product documentation.

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ISO 5832-2:2018 specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in ISO 5832-2:2018.

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ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.

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ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements.
NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

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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.

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ISO 19448:2018 specifies test methods for the quantification of fluoride concentrations in dental products including dentifrices, gels, oral rinses, fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ion-selective electrode technology for the analysis of fluoride in aqueous samples derived from dental products.

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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).

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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.

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ISO 9917-2:2017 specifies requirements and test methods for water-based dental cements in which setting is achieved by a combination of an acid-base reaction and polymerization. The materials are intended for luting, base or lining, restoration and tooth core build up purposes.
EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition will be able to undergo setting by polymerization.
NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International Standards ISO 4049 and ISO 9917‑1 so that they can consider which is the most appropriate for evaluating any individual product.

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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.

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ISO 11609:2017 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.
ISO 11609:2017 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 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.

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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.

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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.

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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.

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ISO 16409:2016 specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer's instructions for use and labelling of the packaging.
Excluded are interdental brushes with a plastic core.
ISO 16409:2016 is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments.

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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.

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

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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.

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ISO 5832-3:2016 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti 6-AI4-V alloy) for use in the manufacture of surgical implants.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

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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.

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ISO 7153-1:2016 specifies metals commonly used to manufacture various types of standard surgical instruments, including but not limited to those used in general surgery, orthopaedics and dentistry.
While ISO 7153-1:2016 is not intended for surgical instruments used in special applications, such as implantology and minimally invasive surgery, parts of it might be applicable to those instruments.

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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 17254:2016 applies to coiled springs for use in orthodontic appliances.
It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

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