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.

Sphygmomanomètres non invasifs

General Information

Status
Published
Publication Date
02-Feb-2020
Current Stage
6060 - International Standard published
Start Date
27-Dec-2019
Completion Date
03-Feb-2020
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ISO/TS 81060-5:2020 - Non-invasive sphygmomanometers
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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
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ISO/TS 81060-5:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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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 ........................................................................................................................ 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 2020 – All rights reserved iii
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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

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

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).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

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
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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.
© ISO 2020 – All rights reserved v
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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 2020 – All rights reserved 1
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ISO/TS 81060-5:2020(E)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14155:2011, ISO 81060-1:2007,

IEC 60601-1:2005+AMD1: 2012, IEC 60601-2-30:2018 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
NOTE An index of defined terms can be found in Annex B.
3.1
* non-invasive blood pressure stimulator
NIBP simulator

device generating artificial blood pressure oscillations in the pneumatic system of automated

sphygmomanometers, which is used to test automated sphygmomanometers

Note 1 to entry: NIBP simulators are not able to confirm the accuracy of an automated sphygmomanometer. They

are used to assess the repeatability and reproducibility of the automated sphygmomanometer.

Note 2 to entry: Not a
...

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