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 ISOÂ 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 requirements and test methods for intraoral cameras used in dentistry on the patient for pictorial representation of the oral cavity 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/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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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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This document specifies general requirements and test methods for accuracy of electronic apex locator that use more than two different frequencies to determine root canal length during root canal treatment.

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This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator's stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. 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.

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This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging.

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This document applies to central compressed air source equipment for dental compressed air used in dentistry. It specifies functional requirements for compressed air source equipment and quality requirements for the dental compressed air produced by the compressed air source equipment.
This International Standard specifies the purity level of dental compressed air and test procedures for central compressed air source equipment and test procedures for the quality requirements for dental compressed air.
It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the compressed air source equipment.
This International Standard only applies to central compressed air source equipment located outside of the dental treatment room.
Dental compressors located in the dental treatment room and facility piping are excluded from the scope of this International Standard.

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This document specifies requirements and test methods for central compressed air source equipment supplying dental air for dental units and various dental air consuming devices in the dental office. It also specifies quality requirements and test methods for the dental air produced by the central compressed air source equipment, such as requirements for the purity level of dental air. It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central compressed air source equipment. This document applies only to central compressed air source equipment located outside of the dental treatment room. This document does not apply to central compressed air source equipment located in the dental treatment room and facility piping. This document does not include requirements for dental laboratory applications (e.g. CAD/CAM systems).

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This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system. This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel. It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.

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2020-03-17-JO- BT decision BT164/DG11529/DV to remove the link to the MDD (93/42/EEC)
Publication on hold due to negative assessment

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EN-IEC 80601-2-60 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE OF DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES AND DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

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This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures.
It specifies shapes and dimensions as well as information for marking.

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EN-ISO 15098 specifies general requirements and test methods for metallic dentaltweezers of the Meriam type and for College type. This document is notapplicable to anatomical tweezers and surgical tweezers.

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This document specifies dimensional and other requirements for the 11 most commonly used carbide cutters which are predominantly used in the dental laboratory.
NOTE These cutters are also used in podiatry.

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EN-ISO 9997 specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics.This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

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

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This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures.
It specifies shapes and dimensions as well as information for marking.

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This document specifies dimensional and other requirements for the 11 most commonly used carbide cutters which are predominantly used in the dental laboratory. NOTE These cutters are also used in podiatry.

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

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    11 pages
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  • Standard
    11 pages
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This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics.
This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.
This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

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This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures. It specifies shapes and dimensions as well as information for marking.

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    7 pages
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  • Standard
    7 pages
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This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics. This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure. This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

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This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT.
NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below.
NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis.
NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment).
NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist.
The scope of this standard is restricted to X-RAY EQUIPMENT where:
• the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and
• the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged
in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE.
NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard.
NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field.
NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard.
NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.

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

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This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

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

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This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

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This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information.
This document is applicable to brackets and tubes for use in fixed orthodontic appliances.
This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

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

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This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information.
This document is applicable to brackets and tubes for use in fixed orthodontic appliances.
This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

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This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labelling information. This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This document does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993‑1 and ISO 7405.

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This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity.
In addition, specific requirements for metallic casing and metallic handles are given.

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

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This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requirements for metallic casing and metallic handles are given.

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

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This International Standard specifies requirements and their test methods for oral surgical scalpel handles used in dentistry especially for oral surgical procedures such as gingival tissue cutting and making surgical incisions. It also specifies the requirements for their marking and labelling.

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

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This International Standard specifies requirements and their test methods for trephine burs used in dentistry especially for oral surgical implant procedures such as collecting bones and removing the fractured implant. It also specifies the requirements for their marking and labelling.

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

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This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.

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

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

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This document specifies requirements and their test methods for trephine burs used in dentistry especially for oral implantology procedures such as collecting bone and/or removing an implant. It also specifies requirements for their marking and labelling.

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

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

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

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

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

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

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