ISO/TC 106/SC 4/WG 7 - Dental Handpieces

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.

This document specifies requirements, test methods, instructions for use and marking for multifunction handpieces (colloquially called "syringes") intended to be used in the oral cavity of the patient. This document does not apply to dental handpieces and motors, intraoral cameras, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas and saliva ejectors.

ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1). ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect. ISO 20608:2018 is also applicable to 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 removal of cement residues where abrasion is part of the desired outcome. ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces. ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).

ISO 14457:2017 specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer's information, marking and packaging. ISO 14457:2017 is applicable to the following: a) straight and angle handpieces; b) high-speed air turbine handpieces; c) air motors; d) electrical motors; e) prophy handpieces. ISO 14457:2017 is not applicable to the following: - intraoral camera handpieces; - powered polymerization handpieces; - air-powered scalers; - electrical-powered scalers; - powder jet handpieces; - multifunction handpieces (syringes). NOTE See Annex A for clarification of handpieces and motor types covered by ISO 14457:2017.

ISO 3964:2016 specifies the coupling between handpieces and motors connected to dental units. ISO 3964:2016 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.

ISO 18397:2016 specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.

ISO 9168:2009 is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces. ISO 9168:2009 specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust.

ISO 22374:2005 specifies requirements and test methods for electrical-powered scalers and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.

Gives requirements and test methods for dental low-voltage electrical motors used in connection with dental handpieces. It also contains specifications on manufacturer's instructions, packaging and marking. Refers to IEC 601-1, the basic standard on safety of medical electrical equipment.

Specifies requirements and test methods for straight and geared angle dental hand instruments for application to patients. Contains also specifications on manufacturer's instructions, marking and packaging.

Specifies four types of standard connectors. Type A: connector with two or three outlets; Type B: connector with four or five outlets; Type C: connector with four outlets and electrical contacts; Type D: connector with three outlets and connection thread M12 x 0,5.

Specifies the nominal dimensions and tolerances of the swivel-type coupling used between the dental handpieces and their driving mechanisms. It is not applicable to the older "slip-joint" coupling and restricted to mechanically coupled handpieces of the slow or medium speed types.