ISO 7494-1:2018
Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements

Standard No.

ISO 7494-1:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 7494-1:2018

Scope

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.

ISO 7494-1:2018 Referenced Document

• IEC 62304:2006 Medical device software - Software life cycle processes
• IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
• 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 10637:2018 Dentistry - Central suction source equipment
• 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 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14457:2017 Dentistry - Handpieces and motors
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• 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 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment
• 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 7493:2006 Dentistry - Operator's stool
• 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
• ISO 9680:2014 Dentistry - Operating lights
• ISO 9687:2015 Dentistry - Graphical symbols for dental equipment

ISO 7494-1:2018 history

• 2018 ISO 7494-1:2018 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
• 2011 ISO 7494-1:2011 Dentistry - Dental units - Part 1: General requirements and test methods
• 2004 ISO 7494-1:2004 Dentistry - Dental units - Part 1: General requirements and test methods