Norm

ISO/DIS 80601-2-55:2016 en

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

  • Deze norm is niet direct leverbaar vanuit de NEN-shop.
    Wilt u dit product bestellen neemt u dan contact op met NEN-klantenservice: (015) 2 690 391 of klantenservice@nen.nl

Over deze norm

Status Ontwerp
Aantal pagina's 62
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 30-09-2016
Taal Engels
This document specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE o f a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This document specifies requirements for - anaesthetic gas monitoring, - carbon dioxide monitoring, and - oxygen monitoring. This document is not applicable to an RGM intended for use with flammable anaesthetic agents. 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 275 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 document are not covered by specific requirements in this document except in 278 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. IEC 60601-1:2005+AMD1:2012, 1.2 is replaced by: The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-55: Bijzondere eisen voor basisveiligheid en essentiële 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

Winkelwagen

Subtotaal:

Ga naar winkelwagen