Norm

NEN-EN-ISO 80601-2-13:2012 en

Medische elektrische toestellen - Deel 2-13: Bijzondere eisen voor de basisveiligheid en essentiƫle eigenschappen van een anesthesiesysteem

179,33

Over deze norm

Status Definitief
Aantal pagina's 99
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-12-2012
Taal Engels
This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional OPERATOR. This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form an ANAESTHETIC WORKSTATION to a given specification: - ANAESTHETIC GAS DELIVERY SYSTEM; - ANAESTHETIC BREATHING SYSTEM; - ANAESTHETIC GAS SCAVENGING SYSTEM; - ANAESTHETIC VAPOUR DELIVERY SYSTEM; - ANAESTHETIC VENTILATOR; - MONITORING EQUIPMENT; - ALARM SYSTEM; An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME EQUIPMENT or ME SYSTEMS with regard to the general standard. This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect theIf a clause or subclause is specifically intended to be applicable to ANAESTHETIC WORKSTATION components 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 an ANAESTHETIC WORKSTATION and its individual components, as relevant. HAZARDS inherent in the intended physiological function of an ANAESTHETIC WORKSTATION and its individual components within the scope of this International Standard are not covered by specific requirements in this International Standard except in 7.2.13 and 8.4.1 of the general standard. This International Standard is not applicable to any ANAESTHETIC WORKSTATION intended for use with flammable anaesthetic agents, as determined by Annex BB. BASIC SAFETY and ESSENTIAL PERFORMANCE of the ANAESTHETIC WORKSTATION.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-13: Bijzondere eisen voor de basisveiligheid en essentiƫle eigenschappen van een anesthesiesysteem
Engelse titel Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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