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Publication details

Publication CODE Title
ISO TS 81060-5:2020 (2020-02) NON-INVASIVE SPHYGMOMANOMETERS - PART 5: REQUIREMENTS FOR THE REPEATABILITY AND REPRODUCIBILITY OF NIBP SIMULATORS FOR TESTING OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS
 
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Description
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.
In addition, the pulse rate set on the NIBP simulator is tested.
This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).
NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.
This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.
NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.
This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2020-02-03
ICS-Code (International Standards Classification) 11.040.10
NBN Status New
IEC publication date 2020-02-03
IEC stability date 2023-12-31
IEC file modification date 2020-02-07
IEC last modification date 2020-02-07