Norm

NEN-EN-IEC 60601-2-65:2013 en

Medisch-elektrische toestellen - Deel 2-65: Bijzondere eisen voor de basisveiligheid en essenti?le prestaties voor tandheelkundige r?ntgen-apparatuur

208,31

Over deze norm

Status Definitief
Aantal pagina's 46
Commissie Medische elektrische toestellen
Gepubliceerd op 01-01-2013
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment - Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment - Particular requirements for the safety of associated equipment of X-ray equipment. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.

Details

ICS-code 11.040.50
Nederlandse titel Medisch-elektrische toestellen - Deel 2-65: Bijzondere eisen voor de basisveiligheid en essenti?le prestaties voor tandheelkundige r?ntgen-apparatuur
Engelse titel Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

Winkelwagen

Subtotaal:

Ga naar winkelwagen