This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

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  • Standard
    12 pages
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This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

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This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

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This document specifies polymers commonly used in manufacturing dental instruments. It is applicable to polymers used to manufacture either an entire instrument or part of an instrument. It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not. This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers. This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

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  • Standard
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This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

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    18 pages
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  • Standard
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  • Standard
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  • Standard
    1 page
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  • Standard
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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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    18 pages
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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 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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    11 pages
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  • Standard
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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.

  • Standard
    22 pages
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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.

  • Standard
    13 pages
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  • Standard
    14 pages
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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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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
    11 pages
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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.

  • Standard
    14 pages
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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
    7 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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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 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.

  • Standard
    19 pages
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  • Standard
    19 pages
    French language
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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 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.

  • Standard
    21 pages
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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.

  • Standard
    19 pages
    English language
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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.

  • Standard
    11 pages
    English language
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  • Standard
    12 pages
    French language
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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.

  • Standard
    21 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.

  • Standard
    13 pages
    English language
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  • Standard
    15 pages
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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.

  • Standard
    21 pages
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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 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.

  • Standard
    21 pages
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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.

  • Standard
    39 pages
    English language
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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.

  • Standard
    21 pages
    English language
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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.

  • Standard
    21 pages
    English language
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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.

  • Standard
    13 pages
    English language
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  • Standard
    13 pages
    French language
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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.

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

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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.

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

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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.

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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.

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

  • Standard
    21 pages
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  • Standard
    23 pages
    French language
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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.

  • Standard
    11 pages
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  • Standard
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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.

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