Norm

NEN-EN-IEC 80601-2-35:2010 en

Medische elektrische toestellen - Deel 2-35: Speciale eisen voor basisveiligheid en essentiële prestaties van verwarmingstoestellen gebruikt in dekens, kussens en matrassen en bedoeld voor verwarming in medisch gebruik

Volledig inclusief:

253,59

Over deze norm

Status Definitief
Aantal pagina's 70
Commissie Medische elektrische toestellen
Gepubliceerd op 01-01-2010
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this International Standard. 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. If a clause or subclause is specifically intended to apply to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then the clause or subclause is entitled as such. Clauses or subclauses that apply to all types of ME EQUIPMENT within the scope of this standard are not specifically entitled. 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
11.140
Nederlandse titel Medische elektrische toestellen - Deel 2-35: Speciale eisen voor basisveiligheid en essentiële prestaties van verwarmingstoestellen gebruikt in dekens, kussens en matrassen en bedoeld voor verwarming in medisch gebruik
Engelse titel Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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