This International Standard is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer’s information, marking and packaging.
This International Standard is applicable to:
a) straight and geared-angle handpieces, including handpiece attachments;
b) high-speed air turbine handpieces;
c) air motors;
d) electrical motors;
e) prophy handpieces.
This International Standard is not applicable to: 1) intraoral camera handpieces; 2) powered polymerization handpieces; 3) air-powered scalers; 4) electrical powered scalers; 5) air-powder polishing handpieces; 6) multifunction handpieces (syringes).
NOTE See Annex A for clarification of the handpieces, attachments and motor types covered by this International Standard.
ISO 14457:2012 Referenced Document
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 62366 Medical devices - Application of usability engineering to medical devices*, 2014-01-01 Update
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 13295 Dentistry - Mandrels for rotary instruments
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*, 2017-09-30 Update
ISO 1797-1 Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals
ISO 1797-2 Dental rotary instruments; shanks; part 2: shanks made of plastics
ISO 21531 Dentistry - Graphical symbols for dental instruments
ISO 3964 Dentistry — Coupling dimensions for handpiece connectors AMENDMENT 1*, 2016-01-01 Update
ISO 5349-1 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements
ISO 5349-2 Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 2: Practical guidance for measurement at the workplace AMENDMENT 1
ISO 6507-1 Metallic materials — Vickers hardness test — Part 1: Test method*, 2023-08-01 Update
ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry*, 2018-10-01 Update
ISO 7494-1 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements*, 2018-06-01 Update
ISO 9168 Dentistry - Hose connectors for air driven dental handpieces
ISO 9687 Dentistry — Graphical symbols for dental equipment AMENDMENT 1*, 2015-01-01 Update