Comitato Elettrotecnico Italiano

Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dental equipment
 N EN 80601-2-60

Annotation

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.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

Автоматический перевод:

Медицинская Часть 2 электрооборудования: Конкретные требования для основной безопасности и существенной производительности стоматологического оборудования

Этот Международный стандарт относится к ОСНОВНОЙ БЕЗОПАСНОСТИ и СУЩЕСТВЕННОЙ ПРОИЗВОДИТЕЛЬНОСТИ СТОМАТОЛОГИЧЕСКИХ УСТАНОВОК, ЗУБНЫХ СТУЛЬЕВ ПАЦИЕНТА, ЗУБНЫХ НАКОНЕЧНИКОВ и ЗУБНЫХ ОПЕРАЦИОННЫХ ОГНЕЙ, в дальнейшем именуемого СТОМАТОЛОГИЧЕСКОГО ОБОРУДОВАНИЯ.