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

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This document specifies terminology, classification, requirements and test methods for portable suction
equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.
This document applies to portable suction equipment incorporated in a portable dental unit and freestanding
portable suction equipment.
The requirements in this document focus on portability.
This document specifies requirements for information to be supplied by the manufacturer on the
performance, operation and maintenance of portable suction equipment designed and constructed to be
transported for use in non-permanent healthcare environments. This document also specifies requirements
for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human
transport between non-permanent healthcare environments.
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 nonpermanent
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 for portable suction equipment used to provide reduced pressure
and flow at the cannula connector.
This document does not apply to portable suction equipment used for life support or for scavenging
halogenated anaesthetic gases.

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This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.
This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment.
The requirements in this document focus on portability.
This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments.
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 for portable suction equipment used to provide reduced pressure and flow at the cannula connector.
This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.

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This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments. This document applies to portable suction equipment incorporated in a portable dental unit and free-standing portable suction equipment. The requirements in this document focus on portability. This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments. This document also specifies requirements for the instructions to be supplied by the manufacturer on assembling, disassembling and packing for human transport between non-permanent healthcare environments. 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 for portable suction equipment used to provide reduced pressure and flow at the cannula connector. This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.

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  • Standard
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This document provides a system for designating tooth development stages in humans using two ASCII characters.

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This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.

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This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.

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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.

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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.

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    9 pages
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  • Standard
    9 pages
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This document specifies requirements and test methods common to all non-hinged metallic dental hand instruments including materials, hardness, surface finish, resistance to reprocessing and information for marking. It does not specify terms and definitions or classification of specific types of hand instruments. This document excludes powered instruments.

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This document specifies a coding system for specific characteristics of endodontic instruments, with a 12-digit code identifying general and specific characteristics of instruments or groups of instruments. The numerals identify the type of instrument, nominal size, taper, length, working part material, type and material of handle or shank.

  • Technical report
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This document specifies requirements and test methods common to all non-hinged metallic dental hand instruments including materials, hardness, surface finish, resistance to reprocessing and information for marking. It does not specify terms and definitions or classification of specific types of hand instruments. This document excludes powered instruments.

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This document specifies requirements and test methods for hand-held or mechanically operated
auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers,
explorers, cotton broaches and cannulae. This document specifies requirements for size, product
designation, safety considerations, instructions and labelling.

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This document provides a system for designating the loss of dental material and the extension of the
restoration in human teeth. The purpose is to describe the application of new filling and restorative
materials, in addition to amalgam.
This document provides a common basis for the clinical use of modern filling and restorative materials,
as described in the instruction for use of the manufacturer of the restorative materials, by specifying an
internationally accepted restoration classification.

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This document specifies requirements and test methods common to all non-hinged hand instruments used in dentistry, including materials, hardness, surface finish, resistance to reprocessing and information for marking, although some can have additional specific requirements and test methods. This document does not specify terms and definitions or classification of specific types of hand instruments. This document excludes powered instruments. The classification and the shape of working ends of non-hinged hand instruments are excluded from this document.

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  • Standard
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This document specifies test methods for the evaluation of dental restorative materials that are claimed by their respective manufacturers to exert “antibacterial” effects.
This document does not cover tests on the effectiveness of sterilization or disinfection procedures nor shall it be used to demonstrate lack of microbial contamination of medical devices used in dentistry.

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Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative material. This document 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.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.

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This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling.

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This document establishes a system for classifying the location and depth of human tooth restorations preparations.

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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, e.g. inlays, crowns and bridges.

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This document specifies the characteristics of polymer-based composite machinable blanks with
respect to the milling process and provides the test methods that address the clinical issues specific
to those materials. In addition, this document specifies the items to be described on the packaging and
materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for
fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes.
They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of
crowns or bridges from one blank or materials for temporary use.

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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.

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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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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.

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    29 pages
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This document specifies requirements and test methods for hand-held or mechanically operated auxiliary instruments for performing root canal procedures such as barbed broaches, paste carriers, explorers, cotton broaches and cannulae. This document specifies requirements for size, product designation, safety considerations, instructions and labelling.

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    19 pages
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  • Standard
    19 pages
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This document establishes a system for classifying the location and depth of human tooth restorations preparations.

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    3 pages
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  • Standard
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This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects.
NOTE       Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document.
This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.

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This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.
This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.
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 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 described in ISO 24234.

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This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects. NOTE Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document. This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.

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    22 pages
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  • Standard
    22 pages
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This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration. This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking. 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 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 described in ISO 24234.

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    35 pages
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This document specifies the classification of and requirements for waxes used for dental casting (including products intended for CAD/CAM milling) using the lost-wax technique and dental baseplate preparation together with the test methods to be employed to determine compliance with these requirements.
Solid polymer products (such as acrylics) for CAD/CAM work, and thermoplastic or photo-curing resins used in additive processes, are not covered by this document.
This document does not include specific and quantitative requirements for freedom from biological hazards.

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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.

  • Standard
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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.

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    46 pages
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  • Standard
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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.

  • Standard
    14 pages
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This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of crowns or bridges from one blank or materials for temporary use.

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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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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.

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This document gives guidance on substrate selection, storage and handling as well as essential characteristics of tensile bond strength test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. Some specific test methods for tensile bond strength measurements are given in Annex A. This document does not include requirements for components of adhesive materials and their performance.

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  • Technical specification
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This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and materials, as well as descriptions to be included in the instructions for use. The polymer-based composite machinable blanks covered in this document are blanks that are used for fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of crowns or bridges from one blank or materials for temporary use.

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    18 pages
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  • Standard
    18 pages
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This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

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  • Standard
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This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks.
Specific tests are specified in the respective instrument standards, if available.
This document does not specify test methods for materials used for rotary instruments.
NOTE       For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards.
This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

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This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7.
This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

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This document specifies the requirements for acrylic hard type materials used as chairside denture
base relining materials and the test methods to determine compliance with these requirements. This
document also specifies requirements for packaging and marking the products and for the instructions
for use to be supplied by the manufacturer.
Dentures which are relined by chairside denture base relining materials specified by this document are
limited to those of acrylic.
This document is not applicable to either denture base relining materials that are for laboratory use or
soft lining materials.
NOTE 1 Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and
substituted (meth)acrylic acid esters and their polymers.
NOTE 2 Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid
esters) and rubber-modified poly (methacrylic acid esters).

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This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer.
Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic.
This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials.
NOTE 1    Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers.
NOTE 2    Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

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This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks.
Specific tests are specified in the respective instrument standards, if available.
This document does not specify test methods for materials used for rotary instruments.
NOTE       For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards.
This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

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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.

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This document specifies general test methods for rotary instruments used in dentistry. These test methods are used for measuring the dimensional characteristics, neck strength and surface roughness of rotary instruments, such as burs, cutters, polishers, grinding instruments and rotary instruments used for oral surgery such as drills and countersinks. Specific tests are specified in the respective instrument standards, if available. This document does not specify test methods for materials used for rotary instruments. NOTE For materials used for rotary instruments, see ISO 21850-1 and respective instrument standards. This document is not applicable to endodontic instruments. For endodontic instruments, see ISO 3630-1.

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    11 pages
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  • Standard
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This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic. This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials. NOTE 1 Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers. NOTE 2 Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

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  • Standard
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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 report
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  • Technical report
    22 pages
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  • Technical report
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  • Technical report
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  • Technical report
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This document specifies the requirements for enlargers not cited in ISO 3630-1, ISO 3630-3, ISO 3630-4, ISO 3630-5, ISO TR 3630-6 or ISO 3630-7.
This document specifies the requirements for size, marking, product designation, safety considerations, and labelling and packaging, including the instructions for use.

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