ISO/TC 106/SC 6/WG 2 - Dental patient chair and dental unit

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.

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.

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.

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 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.

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 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 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 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 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 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 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.

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.

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.

The 153 symbols specified are to be used on the appropriate piece of equipment and in documents pertaining to dental equipment pieces, e.g. in instructions for use. The symbols are selected specifically for all kinds of dental equipment. The majority of them are taken from the relevant IEC and ISO International Standards.