ISO TS 81060-5:2020
(Main)Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
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.
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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
ISO/TS 81060-5:2020(E)
© ISO 2020
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ii © ISO 2020 – All rights reserved
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 . 7
4.6.1 Procedure . 7
4.6.2 Requirement . 7
4.7 Reproducibility of the shape of oscillation . 8
4.7.1 Procedure . 8
4.7.2 Requirement . 8
Annex A (informative) Particular guidance and rationale . 9
Annex B (informative) Terminology — Alphabetical index of defined terms .10
Bibliography .11
ISO/TS 81060-5:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care,
and Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D,
Electromedical equipment.
A list of all parts in the ISO 81060 series and the IEC 81060 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
ISO/TS 81060-5:2020(E)
Introduction
The repeatability and reproducibility of NIBP simulators intended to test automated sphygmomanometers
should be ensured, as they are often used to check the stability of an automated sphygmomanometer
over time of use, after repair or to compare automated sphygmomanometers of the same type.
This document should be used to determine the quality of the NIBP simulator once it is produced, sold
or received by the responsible organization and thereafter periodically tested for the purpose of quality
control. It specifies acceptance limits for repeatability and reproducibility regarding the amplitude
and shape of the generated oscillations. Indirectly, it also tests the repeatability and reproducibility of
the shape of the envelope of generated oscillations over (cuff ) pressure, since the document specifies
measurements at different static pressures at the same setting of the NIBP simulator, thus measuring
the envelope at 2 or 3 pressure values. If there are reasons to doubt that this number is too low, the
test might be extended to 5 or more static pressures. It is not practically hard to do, to compare the
whole envelope of the generated oscillations by a dynamic process, i.e. by recording the data during
the deflation or inflation of the cuff. This kind of dynamic measurement would require an identical
deflation or inflation curve. Technically, this can be done by a closed-loop process, which is not a simple
task. Since the oscillations at constant pressures are not different from those during small pressure
changes, the proposed approach is adequate.
The tests described in this document should be repeated periodically to ensure the long-term stability
of the NIBP simulator.
In this document, it is intended to balance the tests necessary to ensure the stability of the NIBP
simulator required to work properly and the effort to do it. Many of the recordings required can be
evaluated under different aspects.
In this document, the following print types are used:
— requirements, conformance with which can be verified, and definitions: roman type;
— notes and examples: smaller roman type;
— defined terms and test methods: italic type;
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— “should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
— “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test);
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
TECHNICAL SPECIFICATION ISO/TS 81060-5:2020(E)
Non-invasive sphygmomanometers —
Part 5:
Requirements for the repeatability and reproducibility
of NIBP simulators for testing of automated non-invasive
sphygmomanometers
1 Scope
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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-
automated measurement type
IEC 60601-1:2005+AMD1: 2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 80601-2-30:2018, Medical electrical equipment — Part 2-30: Particular requirements for basic safety
and essential performance of automated non-invasive sphygmomanometers
ISO/TS 81060-5:2020(E)
3 Terms and definitions
For the purposes of t
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