Norm

ISO 80601-2-61:2017(Cor. 2018-02) en

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

164,52 199,07 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 90
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-02-2018
Taal Engels
De enige correctie van deze normen was de header. Tekst was goed. ISO 80601-2-61 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 MEDICAL SERVICES ENVIRONMENT. This document is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. 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 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 201.11 and in 7.2.13 and 8.4.1 of the general standard. This document can also be applied to ME EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This document is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the PATIENT ENVIRONMENT. This document is applicable to PULSE OXIMETER EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply PULSE OXIMETER EQUIPMENT for those environments of use. This document is a particular standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.

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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