This International Standard applies to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces and dental operating lights, hereafter referred to as dental equipment. Excluded are amalgamators, sterilizers and dental X-ray equipment.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because: Sub-clause 201.4.3 is in conflict with another recognized standard, see ANSI/AAMI ES60601-1 listed below.