International Organization for Standardization (ISO)
Latest
ISO 14457:2017
Scope
This document 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.
This document is applicable to the following:
a) straight and angle handpieces;
c) air motors;
e) prophy handpieces.
b) high-speed air turbine handpieces;
d) electrical motors; This document 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 this document.
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
ISO 10650:2015 Dentistry - Powered polymerization activators
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 1101:2017 Geometrical product specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation, location and run-out
ISO 13295:2007 Dentistry - Mandrels for rotary instruments
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 1797:2017 Dentistry - Shanks for rotary and oscillating instruments
ISO 21530:2004 Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants
ISO 21531:2009 Dentistry - Graphical symbols for dental instruments
ISO 2768-1:1989 General tolerances; part 1: tolerances for linear and angular dimensions without individual tolerance indications
ISO 2768-2:1989 General tolerances; part 2: geometrical tolerances for features without individual tolerance indications
ISO 3964:2016 Dentistry - Coupling dimensions for handpiece connectors
ISO 5349-1:2001 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 1: General requirements
ISO 5349-2:2001 Mechanical vibration - Measurement and evaluation of human exposure to hand-transmitted vibration - Part 2: Practical guidance for measurement in the workplace
ISO 6507-1:2005 Metallic materials - Vickers hardness test - Part 1: Test method
ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods
ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpieces
ISO 9687:2015 Dentistry - Graphical symbols for dental equipment