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.
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IEC 60601-1 AMD 1:2012
IEC 60601-1:2005
IEC 62353:2014
IEC 62366-1:2015
IEC 80601-2-60:2012
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 11143:2008 Dentistry -- Amalgam separators
ISO 17664:2017 Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 1942:2009 Dentistry -- Vocabulary
ISO 21530:2004 Dentistry -- Materials used for dental equipment surfaces -- Determination of resistance to chemical disinfectants
ISO 4073:2009 Dentistry -- Information system on the location of dental equipment in the working area of the oral health care provider
ISO 7494-2:2015 Dentistry -- Dental units -- Part 2: Air, water, suction and wastewater systems
ISO 8191-1:1987 Furniture -- Assessment of the ignitability of upholstered furniture -- Part 1: Ignition source: smouldering cigarette
ISO 9168:2009 Dentistry -- Hose connectors for air driven dental handpieces