Norm

NEN-EN-ISO 80601-2-69:2014 en

Medische elektrische toestellen - Deel 2-69: Specifieke eisen voor basisveiligheid en essentiƫle prestaties van zuurstof concentratie apparatuur

143,10

Over deze norm

Status Definitief
Aantal pagina's 42
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-07-2014
Taal Engels
NEN-EN-ISO 80601-2-69 specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private and public well as in commerc transportation as ial aircraft.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-69: Specifieke eisen voor basisveiligheid en essentiƫle prestaties van zuurstof concentratie apparatuur
Engelse titel Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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