Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers

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.

General Information

Status
Published
Publication Date
02-Feb-2020
Current Stage
PPUB - Publication issued
Start Date
19-Mar-2020
Completion Date
07-Feb-2020
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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
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11 pages
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Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 81060-5
First edition
2020-02
Non-invasive sphygmomanometers —
Part 5:
Requirements for the repeatability
and reproducibility of NIBP simulators
for testing of automated non-invasive
sphygmomanometers
Reference number
ISO/TS 81060-5:2020(E)
©
ISO 2020

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ISO/TS 81060-5:2020(E)

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ii © ISO 2020 – All rights reserved

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ISO/TS 81060-5:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirement for technical parameters . 2
4.1 Accuracy of the static pressure . 2
4.1.1 Apparatus . 2
4.1.2 Requirements . 2
4.2 Accuracy of the pulse rate . 4
4.2.1 Apparatus . 4
4.2.2 Requirement . 4
4.3 Repeatability of oscillation amplitudes . 5
4.3.1 Apparatus . 5
4.3.2 Requirements . 5
4.4 Reproducibility of oscillation amplitudes . 5
4.4.1 Apparatus . 5
4.4.2 Requirements . 6
4.5 Repeatability and reproducibility of the envelope of the oscillations. 7
4.6 Repeatability of the shape of oscillations .
...

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