Norm

ISO/DIS 80601-2-61:2016 en

Medische elektrische toestellen - Deel 2-61 - Speciale eisen voor basisveiligheid en essentiële prestaties van pulse oximeterapparatuur voor medisch gebruik

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Over deze norm

Status Ontwerp
Aantal pagina's 104
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 24-10-2016
Taal Engels
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT and the EMERGENCY SERVICES ENVIRONMENT. 187 This document is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory 188 research applications nor to oximeters that require a blood sample from the PATIENT

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-61 - Speciale eisen voor basisveiligheid en essentiële prestaties van pulse oximeterapparatuur voor medisch gebruik
Engelse titel Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

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