Norm

NEN-EN-IEC 80601-2-60:2015 en

Medische elektrische toestellen - Deel 2-60: Speciale eisen voor algemene veiligheid en essentiƫle prestaties van tandheelkundige apparatuur

172,08

Over deze norm

Status Definitief
Aantal pagina's 36
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-IEC 80601-2-60 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.

Details

ICS-code 11.040.01
Nederlandse titel Medische elektrische toestellen - Deel 2-60: Speciale eisen voor algemene veiligheid en essentiƫle prestaties van tandheelkundige apparatuur
Engelse titel Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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