DIN EN ISO 18397:2016-09

Professional removal of plaque and tartar at the dental office is an important factor in the preservation of teeth (for example, prophylaxis, periodontitis treatment). This process is called scaling in medical terminology. It can be performed purely manually with the help of hand instruments or mechanically driven with handpieces and tips. Both procedures are about equally effective, except that the newer machine-driven procedures are considered to have a certain time advantage. This standard describes the machine-driven scalers. Dental scaler handpieces and scaler tips have been used in dental treatment procedures for many years. Scaler handpieces and associated scaler tips have been used for many years. The development of new instrument tips has extended the range of indications for the sonic and ultrasonic scalers used for this purpose to the subgingival area. As technical development has resulted in improved scaler handpieces and tips, this revised International Standard is necessary to ensure the level of safety and performance, both of the individual devices and in combination, is at an appropriate level. This International Standard 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. The International Standard has been prepared by ISO/TC 106/SC 4/WG 7 "Dental Handpieces" (secretariat: DIN), in collaboration with CEN/TC 55 "Dentistry" (secretariat: DIN). Working Group NA 014-00-05-05 AK HKL-Systeme ("Dental HKL systems") of NA 014-00-05 AA Zahnärztliche Ausrüstung ("Dental equipment") at NADENT is responsible at DIN. The standard represents the combination of the two standards (DIN EN ISO 15606:2000-07 and DIN EN ISO 22374:2005-12) that have been combined into one standard to cover air-powered and electric-powered scalers. To facilitate application, a calculation example for the output power of the scaler tips has been newly included in Annex A.