Norm

NEN-EN-ISO 9919:2003 Ontw. en

Medische elektrische toestellen - Speciale eisen voor basisveiligheid en essentiƫle prestaties van pulse oximeterapparatuur voor medisch gebruik

  • Deze norm is ingetrokken sinds 06-04-2005

51,12

Over deze norm

Status Ingetrokken
Aantal pagina's 88
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-10-2003
Taal Engels
This Particular Standard specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment. This includes any part necessary for normal use, e.g., the pulse oximeter monitor, pulse oximeter probe, or cable. These requirements apply as well to pulse oximeter equipment including pulse oximeter monitors, pulse oximeter probes, and cables that have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen hemoglobin saturation and pulse rate on hospitalized and non-hospitalized patients including home care applications. Pulse oximeter equipment intended for use in laboratory research applications and an oximeter that requires a blood sample from the patient are outside the scope of this Particular Standard. Pulse oximeter equipment intended for monitoring a fetus is outside the scope of this Particular Standard. Remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment are outside the scope of this Particular Standard.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Speciale eisen voor basisveiligheid en essentiƫle prestaties van pulse oximeterapparatuur voor medisch gebruik
Engelse titel Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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