11.060.20 - Dental equipment

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) den...view more

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.

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...view more

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.

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 compress...view more

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, installati...view more

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 instrum...view more

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

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 inher...view more

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.

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.

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.

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 w...view more

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.

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.

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.

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.

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 syri...view more

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.

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 syring...view more

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 par...view more

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.

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.

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

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.

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.

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

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.

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.

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.

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

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.

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

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 cove...view more

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.

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.

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.

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.

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 covere...view more

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.

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.

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.

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 ...view more

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 equi...view more

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.

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.

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 equipme...view more

This document specifies requirements for electrically-powered mixing machines for mixing dental
amalgam alloy, and dental mercury in capsules to produce dental amalgam.
This document specifies the test methods used to determine conformity with these requirements.
This document refers to those machines that mix by an oscillating action and which are sold by the
manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing
any other type of product.
This d...view more

This International Standard applies to air driven powder jet handpieces and their associated powders for use in the field of dentistry on patients to remove dental debris, discolourations and plaque and to clean and polish teeths where abrasion is a side effect.
It is also applicable to air driven powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the remo...view more