Non-invasive sphygmomanometers. Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
11.040.10 - Anaesthetic, respiratory and reanimation equipment
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).
These parameters can be tested separately in a
clinical investigation or by using different special test
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.
Usually this is tested by a
clinical investigation according
ISO 81060-2 or other
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.
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