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SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 81060-3:2022(E)
© 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: [email protected]
Website: www.iso.org
Published in Switzerland
ii
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
iii
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
...