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  • ISO
    ISO/TS 81060-5:2020 Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
    Edition: 2020
    $192.38
    / user per year

Content 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.



About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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