SIST EN ISO 81060-3:2023
(Main)Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
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 NON-INVASIVE AUTOMATED SPHYGMOMANOMETERS used for the DETERMINATION of the BLOOD PRESSURE of a subject.
This document covers CONTINUOUS NON-INVASIVE AUTOMATED SPHYGMOMANOMETERS intended for use in all subject populations (e.g. all age and weight ranges), and all conditions of use (e.g. 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 124 according to this document.
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 81060-3:2022)
Ta dokument določa zahteve in metode za KLINIČNE RAZISKAVE STALNIH NEINVAZIVNIH AVTOMATIZIRANIH SFIGMOMANOMETROV, ki se uporabljajo za določanje krvnega tlaka preiskovanca.
Ta dokument zajema STALNE NEINVAZIVNE AVTOMATIZIRANE SFIGMOMANOMETRE, namenjene uporabi za celoten nabor preiskovancev (npr. ne glede na starost in težo) in pri vseh pogojih uporabe (npr. ambulantno nadzorovanje KRVNEGA TLAKA, nadzorovanje KRVNEGA TLAKA s stresnim testom in monitorji KRVNEGA TLAKA za OKOLJE DOMAČE ZDRAVSTVENE OSKRBE ali samomerjenje ter uporabi v strokovni zdravstveni ustanovi).
Ta dokument določa dodatne zahteve glede razkrivanja za vse SPREMNE DOKUMENTE STALNIH NEINVAZIVNIH AVTOMATIZIRANIH SFIGMOMANOMETROV, ki so bili predmet KLINIČNE RAZISKAVE 124 v skladu s tem dokumentom.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 81060-3:2023
01-april-2023
Neinvazivni sfigmomanometri - 3. del: Klinična validacija kontinuirnih
avtomatiziranih merilnikov krvnega tlaka (ISO 81060-3:2022)
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous
automated measurement type (ISO 81060-3:2022)
Nicht-invasive Blutdruckmessgeräte - Teil 3: Klinische Prüfung der kontinuierlichen
automatisierten Bauart (ISO 81060-3:2022)
Sphygmomanomètres non invasifs - Partie 3: Investigation clinique pour type à
mesurage automatique continu (ISO 81060-3:2022)
Ta slovenski standard je istoveten z: EN ISO 81060-3:2023
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN ISO 81060-3:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 81060-3:2023
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SIST EN ISO 81060-3:2023
EN ISO 81060-3
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2023
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Non-invasive sphygmomanometers - Part 3: Clinical
investigation of continuous automated measurement type
(ISO 81060-3:2022)
Sphygmomanomètres non invasifs - Partie 3: Nicht-invasive Blutdruckmessgeräte - Teil 3: Klinische
Investigation clinique pour type à mesurage Prüfung der kontinuierlichen automatisierten Bauart
automatique continu (ISO 81060-3:2022) (ISO 81060-3:2022)
This European Standard was approved by CEN on 20 October 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 81060-3:2023 E
worldwide for CEN national Members.
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SIST EN ISO 81060-3:2023
EN ISO 81060-3:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 81060-3:2023
EN ISO 81060-3:2023 (E)
European foreword
This document (EN ISO 81060-3:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 205 “Non-
active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2023, and conflicting national standards shall be
withdrawn at the latest by July 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 81060-3:2022 has been approved by CEN as EN ISO 81060-3:2023 without any
modification.
3
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SIST EN ISO 81060-3:2023
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SIST EN ISO 81060-3:2023
INTERNATIONAL ISO
STANDARD 81060-3
First edition
2022-12
Non-invasive sphygmomanometers —
Part 3:
Clinical investigation of continuous
automated measurement type
Sphygmomanomètres non invasifs —
Partie 3: Investigation clinique pour type à mesurage automatique
continu
Reference number
ISO 81060-3:2022(E)
© ISO 2022
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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 below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for the clinical investigation . 4
4.1 Good clinical practice . 4
4.2 General . 4
4.3 Reference method . 5
4.3.1 Reference invasive blood pressure monitoring equipment . 5
4.3.2 Subject requirements . 5
4.3.3 Blood pressure distribution . 7
4.3.4 Arterial reference site . 8
4.4 Lateral difference . 9
4.4.1 General . 9
4.4.2 Sequential procedure . 10
4.4.3 Simultaneous procedure . . 10
4.4.4 Application of lateral difference . 11
4.5 Statistical considerations . 11
4.5.1 General . 11
4.5.2 Intra-class correlation coefficient and number of independent
measurements .12
4.5.3 Procedure to derive the number of subjects and number of repeated paired
measurements per subject .12
5 Methods for clinical investigation .13
5.1 Method for the accuracy of blood pressure determination .13
5.1.1 General .13
5.1.2 Procedure .13
5.1.3 Data analysis .13
5.1.4 Acceptance criteria . 14
5.2 Method for stability . . 16
5.2.1 General . 16
5.2.2 Procedure . 17
5.2.3 Data analysis . 17
5.2.4 Acceptance criteria . 19
5.3 Method for blood pressure changes . 19
5.3.1 Change evaluation interval. 19
5.3.2 General .20
5.3.3 Procedure .20
5.3.4 Data analysis .20
5.3.5 Acceptance criteria . 22
Annex A (informative) Rationale and guidance .23
Bibliography .35
Terminology — alphabetized index of defined terms .36
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
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.
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 or
www.iec.ch/members_experts/refdocs).
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) or the IEC
list of patent declarations received (see https://patents.iec.ch).
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. In the IEC, see www.iec.ch/understanding-standards.
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 62D,
Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 81060 series can be found on the ISO and IEC websites.
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 and
www.iec.ch/national-committees.
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
Introduction
The number of continuously measuring non-invasive automated sphygmomanometers has increased
significantly in the last 10 years. This document 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.
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SIST EN ISO 81060-3:2023
INTERNATIONAL STANDARD ISO 81060-3:2022(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
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.
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.
1
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
ISO 14155:2020, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2019, Medical devices — Application of risk management to medical devices
ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-
automated measurement type
ISO 81060-2:2018+Amd 1:2020, Non-invasive sphygmomanometers — Part 2: Clinical investigation of
intermittent automated measurement type
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
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 14155:2020, ISO 14971:2019,
ISO 81060-1:2007, ISO 81060-2:2018+Amd 1:2020, IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020,
IEC 60601-2-34:2011, IEC 80601-2-30:2018, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
change evaluation interval
time period for which a continuous automated non-invasive sphygmomanometer is demonstrated to track
changes in blood pressure
3.2
continuous automated non-invasive sphygmomanometer
ME equipment estimating blood pressure from each cardiac cycle without arterial puncture and
providing a continual series of blood pressure parameters
Note 1 to entry: While the continuous automated non-invasive sphygmomanometer analyses each heart cycle, this
does not mean the continuous automated non-invasive sphygmomanometer always uses data from each heart cycle
to estimate the blood pressure. Not using data from a specific heart cycle can be useful, for example, to omit data
from premature ventricular contractions.
Note 2 to entry: The only blood pressure parameters considered in this document are systolic blood pressure,
diastolic blood pressure and mean arterial pressure.
Note 3 to entry: This document does not cover usability aspects such as the form and manner of the data display
or output. Hence, this document does not specify a numerical threshold on the minimum output period. However,
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
are not typically considered a continuous automated non-invasive sphygmomanometer.
Note 4 to entry: There is guidance or rationale for this definition contained in Clause A.2.
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
3.3
determination
determination value
result of the process of estimating blood pressure by the continuous automated non-invasive
sphygmomanometer
[SOURCE: IEC 80601-2-30:2018, 201.3.203; modified: replaced automated sphygmomanometer by
continuous automated non-invasive sphygmomanometer]
3.4
initialization
re-initialization
process of the continuous automated non-invasive sphygmomanometer to determine subject- or condition-
specific parameters needed to estimate 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 initialization process during the measurement period.
3.5
intermittent automated non-invasive sphygmomanometer
ME equipment estimating blood pressure from a number of cardiac cycles without arterial puncture and
providing a single set of blood pressure parameters
Note 1 to entry: The only blood pressure parameters considered in this document are systolic blood pressure,
diastolic blood pressure and mean arterial pressure.
Note 2 to entry: There is guidance or rationale for this definition contained in Clause A.2.
3.6
output period
period of time after which a specific continuous automated non-invasive sphygmomanometer provides
updated values for blood pressure parameters (e.g. systolic blood pressure, diastolic blood pressure or
mean arterial pressure)
Note 1 to entry: The output period may be constituted by a number of heart beats.
3.7
paired measurements
two measurements of a subject’s blood pressure, one of which is recorded with the continuous automated
non-invasive sphygmomanometer and the other with the reference method from the same cardiac cycles
Note 1 to entry: The two measurements of blood pressure can be two measurements of systolic blood pressure,
two measurements of diastolic blood pressure or two measurements of mean arterial pressure.
3.8
paired values
pair of blood pressure values as a result of a paired measurement
Note 1 to entry: The pair of blood pressure values can be a pair of systolic blood pressure, a pair of diastolic blood
pressure or a pair of mean arterial pressure values.
3.9
reference measurement
procedure with established accuracy used for the clinical investigation of a continuous automated non-
invasive sphygmomanometer
3.10
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.
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SIST EN ISO 81060-3:2023
ISO 81060-3:2022(E)
4 General requirements for the clinical investigation
4.1 Good clinical practice
The clinical investigation shall conform with the requirements of ISO 14155.
NOTE Some authorities having jurisdiction can have additional requirements.
Check conformance by application of the requirements of ISO 14155.
4.2 General
NOTE 1 There is guidance or rationale for this subclause contained in Clause A.2.
a) The conditions of the clinical investigation shall represent as closely as possible the intended
conditions of use of the continuous automated non-invasive sphygmomanometers.
1) If a target population is specified in the instructions for use, the subjects of the clinical
investigation shall represent that target population as closely as possible.
NOTE 2 Since a clinical investigation as described in this document requires an invasive
reference, reference invasive blood pressure monitoring equipment will be inserted in all subjects included
in the clinical investigation. However, some target populations for the continuous automated non-invasive
sphygmomanometers can include patients who would not be monitored by reference invasive blood
pressure monitoring equipment (e.g. invasive monitoring is contraindicated or not recommended for the
patient’s critical care due to local infection at site, prior surgery/stents in intended vasculature, etc.).
Therefore, there is a limit as to how representative the subjects of the clinical investigation can be for the
target population.
b) For the clinical investigation, different postures (e.g. supine or sitting) shall be evaluated to determine
if they affect the performance of the continuous automated non-invasive sphygmomanometer.
1) If different postures affect the performance of the continuous automated non-invasive
sphygmomanometer, any clinical investigation shall be performed with all subjects in the same
posture.
c) Set up the continuous automated non-invasive sphygmomanometer according to the instructions for
use.
d) Continuous automated non-invasive sphygmomanometers that continuously and non-invasively
provide accurate blood pressure determinations are classified as Type A.
e) In contrast to Type A, continuous automated non-invasive sphygmomanometers that continuously
and non-invasively provide blood pressure values that can have an unknown constant subject-
specific offset are classified as Type T.
NOTE 3 Type T continuous automated non-invasive sphygmomanometers (trending continuous automated
non-invasive sphygmomanometers) provide blood pressure values that are not intended to be absolutely
accurate. However, since these blood pressure values have an unknown constant subject-specific offset, these
continuous automated non-invasive sphygmomanometers enable representations of accurate blood pressure
changes over time.
NOTE 4 Since the blood pressure value
...
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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Published in Switzerland
ii © ISO 2019 – All rights reserved
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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.
iv © ISO 2019 – All rights reserved
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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.
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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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