Norm

NEN-EN-ISO 80601-2-55:2009 Ontw. en

Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiƫle prestaties van ademhalingsgassenmonitoren

  • Deze norm is ingetrokken sinds 06-01-2012

44,69

Over deze norm

Status Ingetrokken
Aantal pagina's 63
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-11-2009
Taal Engels
Subclause 1.1 of the general standard is replaced by: This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of RESPIRATORY GAS MONITORS, RGM, hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This International Standard specifies requirements for: a) anaesthetic gas monitoring, b) carbon dioxide monitoring, and c) oxygen monitoring. This International Standard is not applicable to RESPIRATORY GAS MONITORS intended for use with flammable anaesthetic agents. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:2005 are intended to take precedence over the corresponding general requirements. Environmental aspects are addressed in Annex DD. 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 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiƫle prestaties van ademhalingsgassenmonitoren
Engelse titel Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Vervangt
Vervangen door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

Winkelwagen

Subtotaal:

Ga naar winkelwagen