ISO/TC 106/SC 6 - Dental equipment

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.

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.

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).

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.

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 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.

ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam. ISO 7488:2018 specifies the test methods used to determine conformity with these requirements. ISO 7488:2018 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. ISO 7488:2018 does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.

ISO 13897:2018 specifies the requirements for reusable mixing-capsules intended to contain dental amalgam alloy powder and dental mercury when these are mixed to produce dental amalgam, and the test methods used to determine conformity to these requirements. NOTE ISO 7488 specifies requirements for mixing machines. The requirements for mixing-capsule are not dealt with in ISO 7488, although the mixing-capsule is an essential part of the mixing machine.

ISO 16954:2015 provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or inhibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery systems under laboratory conditions. It does not apply to devices intended to deliver sterile procedural water or sterile solution. It also does not apply to lines, tubing, or hoses that deliver compressed air within the dental unit. It does not establish specific upper limits for bacterial contamination or describe test methods to be used in clinical situations. It also does not establish test methods for evaluating any deleterious side effects potentially caused by treatment methods. The test methods provided in ISO 16954:2015 can be used to test other dental equipment that delivers non-sterile water to the oral cavity.

ISO 7494-2:2015 specifies requirements and test methods concerning a) the configuration of 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 dental unit, c) the quality for incoming water and air, and d) the performance of dental unit suction system. ISO 7494-2:2015 also specifies requirements for instructions for use and technical description. ISO 7494-2:2015 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in ISO 7494-2:2015.

ISO 9687:2015 specifies graphical symbols for dental equipment. It is intended that the symbols are to be used on the appropriate piece of dental equipment and in documents pertaining to dental equipment, for example in instructions for use, marking, labelling, and technical product documentation.

ISO 4073:2009 specifies an information system for the location of items of dental equipment that are used at the working place of the team of the oral health care provider where examination, treatment and other clinical procedures, with the patient directly involved, are carried out. The identification system provides the means of giving general information about the presence of items and of describing relevant characteristics concerning dimensional flexibility and adaptability of the items and parts of their accessories. In addition, ISO 4073:2009 provides definitions for general terms used in the area of dental equipment.

ISO 11143:2008 specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment centre. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, instructions for use, operation and maintenance. All tests described in ISO 11143:2008 are type tests.

ISO 7493:2006 specifies requirements, recommendations and test methods for the operator's stool in the dental office as well as requirements for the manufacturer's instructions for use and for marking and packaging. It also covers recommendations to manufacturers on the design of operator's stools. For purposes of ISO 7493:2006, the term "dental operator" includes dentists, dental assistants and dental hygienists.

ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection. Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing. ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants. ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.

ISO 10650:2015 specifies requirements and test methods for powered polymerization activators in the 385 nm ? 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This International Standard 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 International Standard. ISO 10650:2015 does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures, or other oral dental appliances. This International Standard takes priority over IEC 60601‑1 where specified in the individual clauses of this International Standard.

ISO 9680:2014 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 manufacturers' instructions for use, marking and packaging. ISO 9680:2014 applies to operating lights, irrespective of the technology of the light source. ISO 9680:2014 excludes auxiliary light sources, e.g. from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.

ISO 7494-1:2011 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered. ISO 7494-1:2011 also specifies requirements for manufacturer's instructions, marking and packaging.

ISO 6875:2011 is applicable to all patient chairs, regardless of their construction, and regardless of whether they are operated manually, electrically or by other means, or as a combination of these. ISO 6875:2011 specifies requirements, test methods, manufacturer's information, marking and packaging.

ISO/TS 11080:2009 provides guidelines for type test methods for evaluating the effectiveness of treatment methods intended to improve or maintain the microbiological quality of procedural water from dental units and other dental equipment under laboratory conditions.

ISO/TS 22595-2:2008 applies to compressor units for dental air and specifies quality requirements for dental air, fittings, pipe lines and valves in the plant area, used to source compressed air for the dental units, dental instruments and technical dental lab equipment. ISO/TS 22595-2:2008 gives recommended guidelines for performance as well as test procedures for compressor units for dental air with at least a compressor motor set including compressor head, air receiver, air dryer system, condensed water tap, pressure switch, valves, pipes, fittings and quality requirements for dental air.

ISO 10650-2:2007 specifies requirements and test methods for powered polymerization activators with light-emitting diodes (LED) in the blue wavelength region intended for chair-side use in polymerization of dental polymer-based restorative materials. ISO 10650-2:2007 is not applicable to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

ISO 9680:2007 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 manufacturers' instructions, marking and packaging. ISO 9680:2007 applies to operating lights that are intended to be permanently fixed to the ceiling, or to the wall or to the floor.

ISO/TS 22595-1:2006 is applicable to dental suction equipment in the plant area, used to source suction for the dental equipment specified in ISO 10637. ISO/TS 22595-1:2006 gives recommended guidelines for performance as well as test procedures for dental suction equipment including suction machines, amalgam separators, filters, valves, pipes, fittings and exhaust requirements. ISO/TS 22595-1:2006 is limited to the performance of the suction system at the suction line connection point.

ISO 7494-1:2004 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered. ISO 7494-1:2004 also specifies requirements for manufacturer's instructions, marking and packaging.

ISO 10650-1:2004 specifies requirements and test methods for powered polymerization activators in the blue wavelength region intended for chair-side use in polymerization of dental polymer-based materials. ISO 10650-1:2004 applies to powered tungsten-halogen lamps and rechargeable battery-powered tungsten-halogen polymerization activators. ISO 10650-1:2004 is not applicable to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances. ISO 10650-1:2004 takes priority over IEC 60601-1:1988 where specified in the individual clauses of this International Standard.

ISO 7494-2:2003 specifies requirements and test methods for the materials, design and construction of the water and air supply within dental units in order to ensure that the compressed water and air supplied via the dental unit are of appropriate quality. It includes provisions for the prevention of retraction of oral fluids into the water supply of the dental unit. ISO 7494-2:2003 does not address prevention of contamination and/or proliferation of hazardous microorganisms (for example bacteria, viruses) in the dental unit.

ISO 13897:2003 specifies requirements and test methods for predosed capsules and for reusable capsules used for mixing dental amalgam alloys and mercury.

Is one of a series of International Standards based on IEC 601-1. Specifies requirements and test methods for dental units, regardless of their construction and regardless of whether or not they are electrically powered. Contains also the requirements for manufacturer's instructions, marking and packaging. Replaces the first edition.

specifies requirements for the layout of the connections to the supply and waste lines for dental equipment, dental units, apparatus and devices, both as concerns the building plumbing and as mutually related to each other. Also lays down the relative positions, centres and minimum dimensions to accommodate the water, waste-water and suction supply lines, and adjacent spaces destined for electrical lines and compressed air lines for dental services. Covers requirements for all types of dental units and dental treatment centres.

Deletes, inserts and changes text on pages 1, 2, 5 and 10.

Applies to all dental patient chairs, regardless of their construction and also regardless of whether they are operated manually or electrically or by other means, or as a combination of these. Specifies requirements, test methods, manufacturer's information, marking and packaging. Refers to 601-1:1988, but takes priority over specifications in IEC 601-1.

Specifies requirements and test methods for devices used for dispensing dental amalgam alloys and/or mercury. Includes the dispensing portion of devices which dispense the correct portions of alloy and mercury as well as mix the amalgam in a single, continuous operation. Does not specify requirements and test methods for the efficacy of mixing.

The preferred voltages are: 12; 24; 36; 48; 72; 80; 96; 120; 144; 160; 192; 240.

Lays down a reference plan for the location of items, it gives symbols for the items and a two-digit system for the identification of the combination of items which are used at the working place of a dental team where examination, treatment and other clinical procedures, with the patient direcly involved, are carried out.