Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)

This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient.
This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer.
This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document.
NOTE 1    IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values.
The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers.
NOTE 2    Subject populations can, for example, be represented by age or weight ranges.
NOTE 3    This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject).
This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document.
This document is not applicable to:
—    the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1,
—    the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2,
—    an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or
—    invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.

Nicht-invasive Blutdruckmessgeräte - Teil 3: Klinische Prüfung der kontinuierlichen automatisierten Bauart (ISO 81060-3:2022)

Dieses Dokument legt Anforderungen und Verfahren für die klinische Prüfung von kontinuierlichen automatisierten nichtinvasiven Blutdruckmessgeräten fest, die zur Messung des Blutdrucks bei Patienten eingesetzt werden.
Dieses Dokument gilt nicht für Aspekte der Gebrauchstauglichkeit wie etwa Form und Art der Datenanzeige oder  ausgabe. Daher wird in diesem Dokument kein numerischer Schwellwert für den Mindestausgabzeitraum festlegt. Jedoch gelten kontinuierliche automatisierte nichtinvasive Blutdruck-messgeräte, die Blutdruckparameter (z. B. systolischen Blutdruck, diastolischen Blutdruck oder mittleren arteriellen Blutdruck) mit einem Ausgabezeitraum von deutlich mehr als 30 s liefern, üblicherweise nicht als kontinuierliche automatisierte nichtinvasive Blutdruckmessgeräte.
Da dieses Dokument sowohl kontinuierliche automatisierte nichtinvasive Blutdruckmessgeräte zur Messung von Trends als auch kontinuierliche automatisierte nichtinvasive Blutdruckmessgeräte zur Messung absolut genauer Werte abdeckt und sich ausschließlich mit den Anforderungen für die klinische Prüfung befasst, wird die Darstellungsweise der Ausgabe in diesem Dokument nicht behandelt.
ANMERKUNG 1   In IEC 62366 1 werden Anforderungen für die Anwendung der gebrauchstauglichkeitsorientierten Entwicklung auf Medizinprodukte ausgeführt, was dazu beitragen kann, für den vorgesehenen Anwender erkennbar zu machen, ob die angezeigten Daten absolut genaue Werte oder Trendwerte sind.
Die in diesem Dokument dargelegten Anforderungen und Verfahren für die klinische Prüfung von kontinuierlichen, automatisierten, nichtinvasiven Blutdruckmessgeräten gelten für alle Probandengruppen sowie für alle Anwendungsbedingungen, unter denen kontinuierliche, automatisierte nichtinvasive Blutdruckmessgeräte eingesetzt werden.
ANMERKUNG 2   Probandengruppen können beispielsweise auf der Basis von Alters- oder Körpergewichtsbereichen definiert werden.
ANMERKUNG 3   Dieses Dokument enthält kein Verfahren zur Bewertung der Auswirkungen von Artefakten bei der klinischen Prüfung (z. B. Bewegungsartefakte, die durch Bewegungen des Probanden oder Bewegungen des Untergrundes, auf dem sich der Proband befindet, verursacht werden).
Dieses Dokument legt zusätzliche Anforderungen an die Kennzeichnung von Begleitpapieren für kontinuierliche, automatisierte nichtinvasive Blutdruckmessgeräte fest, die einer klinischen Prüfung nach diesem Dokument unterzogen wurden.
Dieses Dokument ist nicht anwendbar auf die klinische Prüfung von nicht automatisierten Blutdruckmessgeräten wie in ISO 81060 1 beschrieben, die klinische Prüfung von intermittierenden automatisierten Blutdruckmessgeräten wie in ISO 81060 2 beschrieben, von intermittierenden automatisierten nichtinvasiven Blutdruckmessgeräten wie in IEC 80601 2 30 beschrieben oder von invasiven Blutdrucküberwachungsgeräten wie in IEC 60601 2 34 beschrieben.

Sphygmomanomètres non invasifs - Partie 3: Investigation clinique pour type à mesurage automatique continu (ISO 81060-3:2022)

Le présent document spécifie les exigences et les méthodes relatives à l’investigation clinique des sphygmomanomètres automatiques non invasifs à mesurage continu servant à mesurer la pression artérielle d’un patient.
Le présent document ne traite pas des aspects liés à l’aptitude à l’utilisation tels que l’apparence des résultats ou des données affichées, ainsi que la façon dont ils sont présentés. Le présent document ne spécifie pas de seuil numérique sur la période d’étude minimale. Les sphygmomanomètres automatiques non invasifs à mesurage continu fournissant des paramètres de pression artérielle (pression artérielle systolique, pression artérielle diastolique ou pression artérielle moyenne par exemple) sur une période d’étude considérablement plus longue que 30 s ne sont typiquement pas considérés comme des sphygmomanomètres automatiques non invasifs à mesurage continu.
Le présent document traite à la fois des sphygmomanomètres automatiques non invasifs à mesurage continu pour la détermination de tendances et des sphygmomanomètres automatiques non invasifs à mesurage continu à exactitude absolue, et comme il se concentre uniquement sur les exigences de l’investigation clinique. La représentation des données de sortie n’est pas couverte par le présent document.
NOTE 1       L’IEC 62366-1 fournit des exigences concernant l’application de l’ingénierie de l’aptitude à l’utilisation aux dispositifs médicaux. Le processus d’ingénierie de l’aptitude à l’utilisation qui peuvent être utilisés pour clarifier, auprès de l’utilisateur cible, si les données affichées concernent des valeurs à exactitude absolue ou des valeurs de tendance.
Les exigences et méthodes d’investigation clinique des sphygmomanomètres automatiques non invasifs à mesurage continu données dans le présent document s’appliquent à toutes les populations de sujets et toutes les conditions d’utilisation des sphygmomanomètres automatiques non invasifs à mesurage continu.
NOTE 2       Les populations de sujets peuvent par exemple être représentées par tranches d’âge ou gammes de poids.
NOTE 3       Le présent document ne fournit pas de méthode d’évaluation de l’effet des artefacts durant l’investigation clinique (par exemple artefacts de mouvement induits par le mouvement du sujet ou le mouvement de la plateforme supportant le sujet).
Le présent document spécifie des exigences supplémentaires de divulgation d’informations pour les documents d’accompagnement des sphygmomanomètres automatiques non invasifs à mesurage continu ayant subi une investigation clinique conformément au présent document.
Le présent document n’est pas applicable à:
—    l’investigation clinique de sphygmomanomètres non automatiques tels que définis dans l’ISO 81060-1,
—    l’investigation clinique de sphygmomanomètres non invasifs automatiques à usage intermittent tels que définis dans l’ISO 81060-2,
—    des sphygmomanomètres non invasifs automatiques tels que définis dans l’IEC 80601-2-30, ou
—    des appareils de surveillance de la pression artérielle prélevée directement tels que définis dans l’IEC 60601‑2‑34.

Neinvazivni sfigmomanometri - 3. del: Klinična validacija kontinuirnih avtomatiziranih merilnikov krvnega tlaka (ISO/FDIS 81060-3:2022)

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Status
Published
Publication Date
10-Jan-2023
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
11-Jan-2023
Completion Date
11-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 81060-3:2020
01-februar-2020
Neinvazivni sfigmomanometri - 3. del: Klinične raziskave kontinuirnih
avtomatiziranih vrst merjenja (ISO/DIS 81060-3:2019)
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous
automated measurement type (ISO/DIS 81060-3:2019)

Nicht-invasive Blutdruckmessgeräte - Teil 3: Klinische Prüfung der kontinuierlichen

automatisierten Bauart (ISO/DIS 81060-3:2019)

Sphygmomanomètres non invasifs - Partie 3: Validation clinique pour type à mesurage

automatique continu (ISO/DIS 81060-3:2019)
Ta slovenski standard je istoveten z: prEN ISO 81060-3
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN ISO 81060-3:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 81060-3:2020
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oSIST prEN ISO 81060-3:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 81060-3
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-12-13 2020-03-06
Non-invasive sphygmomanometers —
Part 3:
Clinical investigation of continuous automated
measurement type
Sphygmomanomètres non invasifs —
Partie 3: Validation clinique pour type à mesurage automatique continu
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 81060-3:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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ISO/DIS 81060-3:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

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oSIST prEN ISO 81060-3:2020
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Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Requirements specific to the reference methods................................................................................................................ 3

4.1 * Invasive reference method ...................................................................................................................................................... 3

4.1.1 Reference invasive blood pressure monitoring equipment ................................................ 3

4.1.2 Subject requirements ................................................................................................................................................... 3

4.1.3 Blood pressure distribution ................................................................................................................................. 5

4.1.4 * Arterial reference site ............................................................................................................................................. 5

4.2 Auscultatory reference method ............................................................................................................................................... 6

4.2.1 Reference sphygmomanometer ..................................................................................................................... 6

4.2.2 Subject requirements ................................................................................................................................................... 6

4.2.3 Blood pressure distribution ................................................................................................................................ 7

4.2.4 * Observer preparation .............................................................................................................................................. 7

4.2.5 * Reference readings ................................................................................................................................................. 8

4.3 Lateral difference .................................................................................................................................................................................. 9

4.3.1 General...................................................................................................................................................................................... 9

4.3.2 Sequential procedure ................................................................................................................................................ 9

4.3.3 Simultaneous procedure .....................................................................................................................................10

4.3.4 Application of lateral difference ......................................................................................................................10

5 General requirements for the clinical investigation ....................................................................................................10

5.1 Good clinical practice .....................................................................................................................................................................10

5.2 General ........................................................................................................................................................................................................10

5.3 Reference methods ..........................................................................................................................................................................11

6 Methods for clinical investigation ...................................................................................................................................................11

6.1 * Method for the accuracy of blood pressure determination ..................................................................11

6.1.1 Method utilizing the invasive reference method .................. ............................................................11

6.1.2 Method utilizing the auscultatory reference method ..................................................................12

6.1.3 Acceptance criteria .....................................................................................................................................................13

6.2 * Method for blood pressure changes .............................................................................................................................14

6.2.1 Change evaluation interval ............................................................................................................................14

6.2.2 Method utilizing the invasive reference method .................. ............................................................15

6.2.3 Method utilizing the auscultatory reference method ..................................................................17

6.2.4 Acceptance criteria .....................................................................................................................................................19

6.3 * Method for stability ......................................................................................................................................................................19

6.3.1 General...................................................................................................................................................................................19

6.3.2 Procedure .........................................................................................................................................................................19

6.3.3 Data analysis and acceptance criteria ........................................................................................................21

Annex A (informative) Rationale and guidance .....................................................................................................................................22

Annex B (informative) Guidance for the application of this document .........................................................................31

Annex C (informative) Terminology — alphabetized index of defined terms ........................................................33

Bibliography .............................................................................................................................................................................................................................34

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Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that are

members of ISO or IEC participate in the development of International Standards through technical

committees established by the respective organization to deal with particular fields of technical

activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international

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

work. In the field of information technology, ISO and IEC have established a joint technical committee,

ISO/IEC JTC 1.

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 document 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 and IEC 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 on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO's adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

ISO/IEC 81060-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care,

in collaboration with Technical Committee IEC/TC 62, Electrical equipment in medical practice,

Subcommittee 62D, Electromedical equipment, in accordance with ISO/IEC mode of cooperation 5.

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Introduction

The number of continuously measuring non-invasive automated sphygmomanometers has increased

significantly in the last 10 years. This standard is intended to provide the necessary requirements

for clinical investigation to ensure that the essential performance of these sphygmomanometers is at an

adequate level, similar to those standards on intermittent automated non-invasive sphygmomanometer.

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 standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination

of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,

Part 2. For the purposes of this standard, the auxiliary verb:

— “shall” means that conformance with a requirement or a test is mandatory for conformance with

this standard;

— “should” means that conformance with a requirement or a test is recommended but is not mandatory

for conformance with this standard;

— “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.
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oSIST prEN ISO 81060-3:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 81060-3:2019(E)
Non-invasive sphygmomanometers —
Part 3:
Clinical investigation of continuous automated
measurement type
1 Scope

This document specifies the requirements and methods for the clinical investigation of continuous non-

invasive automated sphygmomanometers used for the measurement of the blood pressure of a subject.

Since this document covers both trending devices and absolute accuracy devices and focuses solely on

requirements for the clinical investigation, representation of output is not covered by this document.

NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices

which can be used to clarify for the intended user whether the shown data concerns absolute accurate values or

trending values.

The requirements and methods for the clinical investigation of continuous non-invasive automated

sphygmomanometers provided in this document are applicable to any subject population, and any

condition of use of the continuous non-invasive automated sphygmomanometers.

NOTE 2 Subject populations can, for example, be represented by age or weight ranges.

NOTE 3 Conditions of use can, for example, refer to ambulatory blood pressure monitoring, stress testing blood

pressure monitoring and blood pressure monitors for the home healthcare environment or self-measurement as

well as use in professional healthcare facility or the emergency medical service environment (EMS).

This document specifies additional disclosure requirements for the accompanying documents of

continuous non-invasive automated sphygmomanometers that have undergone clinical investigation

according to this document.

This document is not applicable to the clinical investigation of a non-automated sphygmomanometer as

given in ISO 81060-1, the clinical investigation of an intermittent automated sphygmomanometer as given

in ISO 81060-2, an intermittent automated non-invasive sphygmomanometer as given in IEC 80601-2-30

or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
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.

NOTE Informative references are listed in the Bibliography.

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of medical

devices — Part 1: General essential principles and additional specific essential principles for all non-IVD

medical devices and guidance on the selection of standards

ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-

automated measurement type
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ISO 81060-2:2018, Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent

automated measurement type

IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and

essential performance +Amendment 1:2012

IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety and

essential performance — Collateral standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment

IEC 60601-2-34:2011, Medical electrical equipment — Part 2-34: Particular requirements for the safety,

including essential performance of invasive blood pressure monitoring equipment

IEC 80601-2-30:2018, Medical electrical equipment — Part 2-30: Particular requirements for basic safety

and essential performance of automated non-invasive sphygmomanometers
3 Terms and definitions

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

ISO 81060-2:2018, IEC 60601-1:2005+AMD1: 2012, IEC 60601-2-34:2011, IEC 80601-2-30:2018 and the

following apply.

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

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp

Note 1 to entry For convenience, the sources of all defined terms used in this document are given in Annex C.

3.1
change evaluation interval

time interval for which a continuous non-invasive automated sphygmomanometer is demonstrated to be

able to track changes in blood pressure
3.2
continuous non-invasive automated sphygmomanometer

device able to estimate blood pressure from the pulse wave of each heart cycle without arterial

punctureNote 1 to entry: While the continuous non-invasive automated sphygmomanometer is able to

estimate the blood pressure from the pulse wave of each heart cycle, this does not mean the device

needs to use data from the pulse wave at each heart cycle. Not using data from a pulse wave at a specific

heart cycle can be useful, for example to omit data from premature ventricular contractions.Note 2

to entry: The manufacturer may choose the form and manner of the data display or output.

3.3
initialization
re-initialization

process of the continuous non-invasive automated sphygmomanometer to determine subject- or condition-

specific parameters needed to estimate the blood pressure

Note 1 to entry: In this document, the term initialization is used for the initial initialization; re-initialization is

used for the repeated process during the measurement period.
3.4
intermittent automated non-invasive sphygmomanometer

automated sphygmomanometer estimating at intervals systolic blood pressure, diastolic blood pressure or

mean arterial pressure values over a series of cardiac cycles
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3.5
paired measurement

two measurements of the same blood pressure event within a subject's cardiac cycles, one of which

is recorded with the continuous non-invasive automated sphygmomanometer and the other with the

reference method

Note 1 to entry: An example for a blood pressure event is the occurrence of a systolic or a diastolic blood pressure.

3.6
paired values
pair of blood pressure values as a result of a paired measurement

Note 1 to entry: The blood pressure values can be systolic, diastolic or mean blood pressure values.

3.7
reference measurement

procedure defined in this standard with established accuracy used for the clinical investigation of a

continuous non-invasive automated sphygmomanometer
3.8
reference reading
result of the process of measuring blood pressure using a reference method

Note 1 to entry: The result can be a systolic blood pressure, a diastolic blood pressure or a mean arterial pressure.

4 Requirements specific to the reference methods
4.1 * Invasive reference method
4.1.1 Reference invasive blood pressure monitoring equipment
a) Reference invasive blood pressure monitoring equipment:
1) shall conform with the requirements of IEC 60601-2-34; except that
2) the maximum allowable error shall be ± 2 mmHg (± 0,27 kPa).

b) The resonance frequency and damping coefficient of the reference invasive blood pressure

monitoring equipment shall be shall be examined and optimised to meet dynamic requirements. See

[2]
Reference .
c) The transducer shall be kept at the level of the heart.

d) Appropriate measures shall be taken to remove air bubbles and clots from the system prior to

taking the reference measurements.

NOTE The ability to measure accurately blood pressure can be degraded by the presence of air bubbles

or blood clots in the catheter/transducer system.

e) Reference invasive blood pressure monitoring equipment that does not directly output the blood

pressure waveform or beat-to-beat data may be modified to permit such data collection.

4.1.2 Subject requirements
4.1.2.1 Number
A clinical investigation shall consist of
a) a minimum of 15 subjects,
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b) with the exception of sphygmomanometers intended for use in neonates, infants and children of less

than 3 years of age for which it shall consist of a minimum of 18 subjects.
Check conformance by inspection of the clinical investigation report.
4.1.2.2 Gender distribution
a) At least 30 % of the subjects shall be male.
b) At least 30 % of the subjects shall be female.
Check conformance by inspection of the clinical investigation report.
4.1.2.3 * Age distribution
4.1.2.3.1 Sphygmomanometers intended for use in adults and adolescents

For a continuous non-invasive automated sphygmomanometer intended for use in adult or adolescent

subjects, the age of every subject included in the clinical investigation shall be greater than 12 years.

NOTE Minimum total of 15 subjects.

Check conformance by inspection of the accompanying document and the clinical investigation report.

4.1.2.3.2 Sphygmomanometers intended for use in children aged between 3 years and 12 years

a) For a continuous non-invasive automated sphygmomanometer intended for use in children aged

between 3 years and 12 years, the age of every subject included in the clinical investigation shall be

between 3 years and 12 years.
NOTE Minimum total of 15 subjects.
b) Children are exempt from:
1) the gender distribution requirements of 4.1.2.2; and
2) the blood pressure distribution requirements of 4.1.3.

Check conformance by inspection of the accompanying document and the clinical investigation report.

4.1.2.3.3 Sphygmomanometer intended for use in neonates, infants and children of less than 3

years of age

a) A continuous non-invasive automated sphygmomanometer intended for use in neonates, infants and

children of less than 3 years of age, shall be investigated in those subject populations.

b) The following age or weight ranges are required for a neonatal mode clinical investigation:

1) At least 3 subjects shall be less than 1 000 g in weight.
2) At least 3 subjects shall be 1 000 g to 2 000 g in weight.
3) At least 3 subjects shall be more than 2 000 g in weight.
4) At least 3 subjects shall be at least 29 days but not yet 1 year of age.
5) At least 3 subjects shall be at least 1 year but not yet 3 years of age.

c) The remaining subjects may be from any of the above age or weight groups in order to complete the

sample size of 18.
NOTE 1 Minimum total of 18 subjects.
4 © ISO 2019 – All rights reserved
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oSIST prEN ISO 81060-3:2020
ISO/DIS 81060-3:2019(E)
NOTE 2 A subject can be in more than one category simultaneously.
d) Neonates, infants and children of less than 3 years of age are exempt from:
1) the gender distribution requirements of 4.1.2.2; and
2) the blood pressure distribution requirements of 4.1.3.

Check conformance by inspection of the accompanying document and the clinical investigation report.

4.1.2.4 * Special subject populations

a) When there is evidence that a certain subject characteristic might affect the performance of a

continuous non-invasive automated sphygmomanometer, and if this is within the intended use of the

device, that population (which is well defined by such subject characteristics) shall be considered a

special subject population.

b) The continuous non-invasive automated sphygmomanometer shall be investigated across the range

of the subject characteristics that is within the intended use of the device.

c) Unless otherwise justified, each special subject population identified shall be investigated

separately.

Check conformance by inspection of the accompanying document and the clinical investigation report.

4.1.3 Blood pressure distribution

a) At least 5 % of the reference readings shall have a systolic blood pressure less than or equal to

100 mmHg (13,33 kPa).

b) At least 5 % of the reference readings shall have a systolic blood pressure greater than or equal to

160 mmHg (21,33 kPa).

c) At least 20 % of the reference readings shall have a systolic blood pressure greater than or equal to

140 mmHg (18,67 kPa).

d) At least 5 % of the reference readings shall have a diastolic blood pressure less than or equal to

60 mmHg (8,00 kPa).

e) At least 5 % of the reference readings shall have a diastolic blood pressure greater than or equal to

100 mmHg (13,33 kPa).

f) At least 20 % of the reference readings shall have a diastolic blood pressure greater than or equal to

85 mmHg (11,33 kPa).
Check conformance by inspection of the clinical investigation report.
4.1.4 * Arterial reference site

a) Any reference site may be used for simultaneous comparison of intra-arterial blood pressure readings

and continuous non-invasive automated sphygmomanometer blood pressure determinations, but

b) the instructions for use of the continuous non-invasive automated sphygmomanometer shall disclose

the arterial site used as the reference site.

NOTE Different sites can produce different results due to the pressure difference between the central

aorta and other arteries.

c) If the opposite limb is used as the reference site, the lateral difference in blood pressure may be

determined and used according to 4.3.
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d) A continuous non-invasive automated sphygmomanometer claiming to output central or aortic blood

pressure values shall utilize a central or aortic arterial reference site for the clinical investigation.

Check conformance by inspection of the accompanying document.
4.2 Auscultatory reference method
4.2.1 Reference sphygmomanometer
a) The auscultatory reference measurement shall be performed on the upper arm.

b) Use a reference sphygmomanometer that conforms with the requirements of ISO 81060-1, except

that the maximum permissible error shall be ± 1 mmHg (0,13 kPa).
4.2.2 Subject requirements
4.2.2.1 * Number

a) An auscultatory reference sphygmomanometer validation study shall consist of a minimum of 85

subjects.

b) For each parameter (e. g. systolic or diastolic blood pressure) to be validated at least 3 valid paired

measurements shall be carried out for each subject.

NOTE This results in a minimum of 255 valid paired values for each parameter (e. g. systolic

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