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 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 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 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 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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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 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 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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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 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.

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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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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 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 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. 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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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 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 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 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 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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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 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.

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  • Technical report
    22 pages
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  • Technical report
    23 pages
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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 establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.

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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 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 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.

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This document specifies requirements and test methods for stationary dental units concerning
a) the properties of stationary dental unit connections to the compressed air supply, water supply,
suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the
stationary dental unit,
c) the quality for incoming water and air,
d) the performance of stationary dental unit suction system, and
e) the air, water, suction and wastewater properties of stationary dental unit connections to the
interfaces to dental handpieces.
This document also specifies requirements for instructions for use and technical description.
This document does not specify requirements or test methods for the effectiveness of stationary dental
unit waterline biofilm control.
NOTE Test methods for the effectiveness of stationary dental unit waterline biofilm control are specified in
ISO 16954.
This document is only applicable to stationary dental units that are not used for oral surgery treatment
requiring sterile air and water supplies. Amalgam separators are not included in this document.

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ISO 3107:2011 specifies requirements for non-water-based zinc oxide/eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
ISO 3107:2011 also specifies requirements for non-eugenol cements containing zinc oxide and aromatic oils suitable for temporary cementation.

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This document specifies requirments and test methods for moblie dental units concerning air and water quality.

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This document specifies the requirements and test methods for dental brazing materials suitable for
use in metallic restorations.
Brazing materials with silver as the main component are excluded from this document.

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This documents specifies requirements and test methods for mobile dental units.

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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 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 dental units concerning
a) the properties of stationary dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the stationary dental unit,
c) the quality for incoming water and air,
d) the performance of stationary dental unit suction system, and
e) the air, water, suction and wastewater properties of stationary dental unit connections to the interfaces to dental handpieces.
This document also specifies requirements for instructions for use and technical description.
This document does not specify requirements or test methods for the effectiveness of stationary dental unit waterline biofilm control.
NOTE       Test methods for the effectiveness of stationary dental unit waterline biofilm control are specified in ISO 16954.
This document is only applicable to stationary dental units that are not used for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.

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This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than eugenol for temporary cementation.

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This document specifies the requirements and test methods for mobile dental units concerning:
a) the properties of mobile dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the mobile dental unit,
c) the quality for incoming water and air,
d) the performance of mobile dental unit suction system, and
e) the air, water, suction and wastewater properties of mobile dental unit connections to the interfaces to dental handpieces.
This document also specifies requirements for instructions for use and a technical description.
This document is only applicable to mobile dental units that are not used for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.

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This document specifies the requirements and test methods for mobile dental units and dental patient chairs that is intended to be used within a permanent healthcare facility regardless of whether they are or not electrically powered.
This document also specifies the requirements for the instructions for use, for the technical description, for marking and for packaging.
Operator's stools, stationary dental equipment, other types of mobile dental equipment, portable dental equipment and operating lights are not in the scope of this document.

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This document specifies the requirements and their test methods applicable to all elastomeric
auxiliaries used for orthodontics both inside and outside the mouth, in conjunction with fixed and
removable appliances.

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This document specifies requirements and test methods for metallic materials that are suitable for the
fabrication of dental restorations and appliances. Included are metallic materials recommended for use
either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document
specifies requirements for packaging and marking of the products and for the instructions for use of
these materials, including products delivered for sale to a third party.
This document does not apply to alloys for dental amalgam (see ISO 24234), dental brazing materials
(see ISO 9333), or metallic materials for orthodontic appliances (e.g. wires, brackets, bands and screws).
This document is not applicable to magnetic attachment, which are specified in ISO 13017.

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