SIST EN ISO 81060-2:2020

SLOVENSKI STANDARD
01-februar-2020
Nadomešča:
SIST EN ISO 81060-2:2014
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst
merjenja s prekinitvami (ISO 81060-2:2018)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type (ISO 81060-2:2018)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart (ISO 81060-2:2018)
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à
mesurage automatique (ISO 81060-2:2018)
Ta slovenski standard je istoveten z: EN ISO 81060-2:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 81060-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 81060-2:2014
English Version
Non-invasive sphygmomanometers - Part 2: Clinical
investigation of intermittent automated measurement type
(ISO 81060-2:2018)
Sphygmomanomètres non invasifs - Partie 2: Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische
Investigation clinique pour type ponctuel à mesurage Prüfung der intermittierenden automatisierten Bauart
automatique (ISO 81060-2:2018) (ISO 81060-2:2018)
This European Standard was approved by CEN on 20 November 2019.

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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 81060-2:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative)  Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 81060-2:2019) 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 May 2020, and conflicting national standards shall be
withdrawn at the latest by November 2022.
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.
This document supersedes EN ISO 81060-2:2014.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard “within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
foreword and the Annexes ZZ.
NOTE The way in which these references documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between normative references and dated EN and ISO/IEC standards
Equivalent dated standard
Normative references as listed in
Clause 2
EN ISO/IEC
ISO 14155:2011 EN ISO 14155:2011 ISO 14155:2011
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
ISO 16142-1:2016 – ISO 16142-1:2016
IEC 60601-1:2005+AMD1:2012 EN 60601-1:2006 IEC 60601-1:2005
+AMD1:2013 +AMD1:2012
+AMD12:2014
IEC 60601-1-11:2015 EN 60601-1-11:2015 IEC 60601-1-11:2015
IEC 60601-2-34:2011 EN 60601-2-34:2014 IEC 60601-2-34:2011
IEC 80601-2-30:2018 EN 80601-2-30:2019 IEC 80601-2-30:2018
ISO 81060-1:2007 EN ISO 81060-1:2012 ISO 81060-1:2007
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 81060-2:2018 has been approved by CEN as EN ISO 81060-2:2019 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s joint standardization request M/295
concerning the development of European standards relating to medical devices to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/sub- Remarks/Notes
of Directive 93/42/EEC clause(s) of this EN
Only the characteristics of the
10.1 measurement performance (accuracy),
4, 5 and 6
as well as the corresponding tests
methods, are addressed.
Essential Requirements Clause(s)/sub- Remarks/Notes
of Directive 93/42/EEC clause(s) of this EN
Covered only in respect of certain
additional warnings contained in the
indicated subclauses related to the
following:
− definition of special patient
population;
− that effectiveness has not been
established in the presence of any
dysrhythmias included in the
exclusion criteria, where applicable;
5.1.6 e), 6.2.1 d) 2), 6.2.2
13.6 a) j) − specifying the arterial reference site;
a), 6.2.7, 7 h) and 7 i)
− disclosure of the method used to
determine and verify the mean
arterial pressure;
− suitability for use with pregnant
(including pre-eclamptic) patients,
where applicable;
− that effectiveness has not been
established in pregnant (including
pre-eclamptic) patients, where
applicable.
Covered only in respect of carrying our
clinical investigations with
− reference auscultatory
sphygmomanometers;
Annex X, 2.3.1 to 2.3.3
5, 6 and 7
− reference invasive blood pressure
monitoring equipment; and
− pregnant patient populations, where
applicable.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 81060-2
Third edition
2018-11
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent
automated measurement type
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
Reference number
ISO 81060-2:2018(E)
©
ISO 2018
ISO 81060-2:2018(E)
© ISO 2018
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 81060-2:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for clinical investigations . 2
4.1 Clinical investigation methods . 2
4.2 Good clinical practice . 3
4.3 Status of previous clinical investigations . 3
4.4 Disclosure of summary of clinical investigation . 3
5 Clinical investigation with an auscultatory reference sphygmomanometer .3
5.1 Subject requirements . 3
5.1.1 * Number . 3
5.1.2 * Gender distribution . 3
5.1.3 * Age distribution . 4
5.1.4 * Limb size distribution . 4
5.1.5 Blood pressure distribution . 4
5.1.6 * Special patient populations . 5
5.2 Clinical investigation method with a reference sphygmomanometer . 5
5.2.1 * Subject preparation . 5
5.2.2 * Observer preparation . 6
5.2.3 * Reference readings. 6
5.2.4 Clinical investigation methods . 7
5.2.5 * Additional requirements for a sphygmomanometer intended for use in
exercise stress testing environments .15
5.2.6 * Additional requirements for a sphygmomanometer intended for use in
ambulatory monitoring .16
6 Clinical investigation with reference invasive blood pressure monitoring
equipment .17
6.1 Patient requirements .17
6.1.1 Number .17
6.1.2 * Gender distribution .17
6.1.3 * Age distribution .17
6.1.4 Limb size distribution .18
6.1.5 Blood pressure distribution .18
6.1.6 Special patient populations .19
6.2 Clinical investigation methods with reference invasive blood pressure
monitoring equipment .19
6.2.1 * Reference measurement .19
6.2.2 * Arterial reference site .20
6.2.3 Procedure .20
6.2.4 * Determining the reference blood pressure .21
6.2.5 Determining the error of the blood pressure measurement .22
6.2.6 Data analysis .22
6.2.7 Mean arterial pressure (map) .23
7 * Pregnant patient populations .23
Annex A (informative) Rationale and guidance .25
Annex B (informative) Reference to the essential principles .33
Annex C (informative) Terminology — alphabetized index of defined terms .34
Bibliography .35
ISO 81060-2:2018(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).
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 http: //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.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care,
and Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D,
Electromedical equipment.
This third edition cancels and replaces the second edition (ISO 81060-2:2013), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— same arm simultaneous method has been deleted;
— numerous clarifications have been added and kPa equivalent values for the mmHg values have
been included.
A list of all parts in the ISO/IEC 81060 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved

ISO 81060-2:2018(E)
Introduction
Determining blood pressure is an important procedure that is clinically used to assess the status of
a patient.
Blood pressure serves as aid to control the drug titration and fluid management and to provide
warning about the changes in patient’s state of health.
Frequently determining blood pressure is routine during anaesthesia. Blood pressure serves to
aid to control drug titration and fluid management and to provide warning about the changes in the
patient's state of health.
In this document, the following print types are used:
— requirements, compliance with which can be verified, and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
roman type. Normative text of tables is also in a smaller roman type;
— test methods: italic type; and
— terms defined in clause 3 of the general standard, in this document or as noted: small
capitals type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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.
Annex B maps the clauses and subclauses of this document with the essential principles of
ISO 16142-1:2016.
INTERNATIONAL STANDARD ISO 81060-2:2018(E)
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
1 Scope
This document specifies the requirements and methods for the clinical investigation of
me equipment used for the intermittent non-invasive automated estimation of the arterial blood
pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations, flow or
sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need
not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient 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
for self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation
according to this document.
This document specifies additional disclosure requirements for the accompanying documents of
sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers
as given in ISO 81060-1 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 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
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
IEC 60601-1:2005+Amendment 1:2012, Medical electrical equipment — Part 1: General requirements for
basic safety and essential performance
ISO 81060-2:2018(E)
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 home care applications
IEC 60601-2-34:2011, Medical electrical equipment — Part 2-34: Particular requirements for the basic
safety and 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 14155:2011, ISO 14971:2007,
ISO 16142-1:2016, ISO 81060-1:2007, IEC 60601-1:2005+AMD1: 2012, IEC 60601-1-11:2015, IEC 60601-2-
34:2011 and IEC 80601-2-30:2018, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
NOTE For convenience, an alphabetized index of defined terms is found in Annex C.
3.1
intermittent
utilizing a process of estimating blood pressure that provides
a single set of pressure values from a number of heart beats
3.2
reference
ref
established accuracy used for the clinical investigation of other instruments
3.3
sphygmomanometer
me equipment for non-invasive estimation of systemic arterial blood pressure
3.4
sphygmomanometer-under-test
sut
automated sphygmomanometer undergoing clinical investigation
4 General requirements for clinical investigations
4.1 Clinical investigation methods
a) Automated sphygmomanometers shall undergo clinical investigation according to this
document in each mode of operation by either using:
1) a non-invasive auscultatory reference sphygmomanometer at the upper arm; or
2) a reference invasive blood pressure monitoring equipment.
EXAMPLE 1 Adult and neonatal modes.
EXAMPLE 2 Slow and fast cuff deflation rate modes.
b) A clinical investigation shall be considered a type test.
2 © ISO 2018 – All rights reserved

ISO 81060-2:2018(E)
c) An automated sphygmomanometer intending to display central or aortic blood pressure shall
utilize a central or aortic invasive reference site for clinical investigation (see 6.2.2).
NOTE Such an automated sphygmomanometer is investigated according to Clause 6.
Consider compliance with the requirements of this subclause to exist when the criteria of the relevant
inspections and tests in this document are met.
4.2 Good clinical practice
a) All clinical investigations shall comply with the requirements of ISO 14155:2011.
b) Clinical investigation with reference invasive blood pressure monitoring equipment should
not be used for patients or subjects solely for the purpose of investigating sphygmomanometer
performance.
NOTE Some authorities having jurisdiction have additional requirements.
c) The requirements of this document, which are more specific than the corresponding requirements
of ISO 14155:2011, shall prevail.
Check compliance by application of the requirements of ISO 14155:2011.
4.3 Status of previous clinical investigations
The clinical investigation results for sphygmomanometers that have been successfully clinically
investigated according to previous versions of ISO 81060-2 remain valid and a clinical investigation
need not be repeated to comply with this document.
4.4 Disclosure of summary of clinical investigation
The technical description of a sphygmomanometer shall contain contact information permitting the
responsible organization to acquire a copy of the summary of the clinical investigation.
5 Clinical investigation with an auscultatory reference sphygmomanometer
5.1 Subject requirements
5.1.1 * Number
a) An auscultatory reference sphygmomanometer clinical investigation shall consist of a
minimum of 85 subjects.
b) If not otherwise specified, at least three valid paired blood pressure values shall be taken for
each subject [see 5.2.4.1.1 o)].
c) There shall be a minimum of 255 valid paired blood pressure values.
Check compliance by inspection of the clinical investigation report.
5.1.2 * Gender distribution
a) At least 30 % of the subjects shall be male.
b) At least 30 % of the subjects shall be female.
Check compliance by inspection of the clinical investigation report.
ISO 81060-2:2018(E)
5.1.3 * Age distribution
a) For a sphygmomanometer intended for use on adults or adolescent patients, the age of every
subject included in the clinical investigation shall be greater than 12 years.
NOTE 1 Minimum total of 85 subjects.
b) For a sphygmomanometer additionally intended for use in children, 35 child subjects aged between
3 years and 12 years shall be included in the clinical investigation.
NOTE 2 Minimum total of 85 subjects (35 children aged 3-12 years and 50 subjects older than 12 years).
c) If the sphygmomanometer has a special mode for children, in that mode, children shall be
considered a special patient population (see 5.1.6). In such a study, children are exempt from the
blood pressure distribution requirements of 5.1.5.
d) Children aged less than 3 years shall not be included in a clinical investigation utilizing
auscultatory reference readings by observers with a reference sphygmomanometer.
Check compliance by inspection of the accompanying document and the clinical investigation report.
5.1.4 * Limb size distribution
a) For a sphygmomanometer intended for use with a single cuff size:
1) at least 40 % of the subjects shall have a limb circumference which lies within the upper half of
the specified range of use of the cuff;
2) at least 40 % of the subjects shall have a limb circumference within the lower half of the
specified range of use of the cuff;
3) at least 20 % of the subjects shall have a limb circumference which lies within the upper
quarter of the specified range of use of the cuff;
4) at least 20 % of the subjects shall have a limb circumference within the lower quarter of the
specified range of use of the cuff; and
5) at least 10 % of the subjects shall have a limb circumference which lies within the upper octal
of the specified range of use of the cuff; and
6) at least 10 % of the subjects shall have a limb circumference within the lower octal of the
specified range of use of the cuff.
b) For a sphygmomanometer intended for use with multiple cuff sizes:
1) each cuff size shall be tested on at least of the total number of subjects, where n is the
2×n
number of cuff sizes; and
2) at least 40 % of the subjects shall have a limb circumference which lies within the upper half of
the specified range of use of the cuff; and
3) at least 40 % of the subjects shall have a limb circumference within the lower half of the
specified range of use of the cuff.
Check compliance by inspection of the accompanying document and the clinical investigation report.
5.1.5 Blood pressure distribution
a) At least 5 % of the reference blood pressure readings shall have a systolic blood pressure
≤100 mmHg (13,33 kPa).
4 © ISO 2018 – All rights reserved

ISO 81060-2:2018(E)
b) At least 5 % of the reference blood pressure readings shall have a systolic blood pressure
≥160 mmHg (21,33 kPa).
c) At least 20 % of the reference blood pressure readings shall have a systolic blood pressure
≥140 mmHg (18,66 kPa).
d) At least 5 % of the reference blood pressure readings shall have a diastolic blood pressure
≤60 mmHg (8,0 kPa).
e) At least 5 % of the reference blood pressure readings shall have a diastolic blood pressure
≥100 mmHg (13,33 kPa).
f) At least 20 % of the reference blood pressure readings shall have a diastolic blood pressure
≥85 mmHg (11,33 kPa).
Check compliance by inspection of the clinical investigation report.
5.1.6 * Special patient populations
a) A sphygmomanometer that is intended for use in special patient populations where there is
objective evidence that the accuracy of the sphygmomanometer might be problematic in those
patient populations, shall undergo clinical investigation in those patient populations.
NOTE Clause 7 has a specific example of a special patient population with specific requirements.
b) If the sphygmomanometer has passed clinical investigation according to the requirements
of 5.1.1 and 5.2, it shall then undergo clinical investigation in at least an additional 35 special
population subjects.
c) If the sphygmomanometer has not successfully undergone clinical investigation according to
the requirements of 5.1.1 and 5.2, the clinical investigation in accordance with the requirements
of 5.1.1 and 5.2 shall consist only of subjects from the special patient population.
d) The special patient population shall be defined in clear terms and address the following attributes:
1) gender (see 5.1.2);
2) age (see 5.1.3);
3) limb size (see 5.1.4); and
4) blood pressure (see 5.1.5).
e) A summary of the definition of the special patient population information shall be disclosed in the
instructions for use.
Check compliance by inspection of the instructions for use and the clinical investigation report.
5.2 Clinical investigation method with a reference sphygmomanometer
5.2.1 * Subject preparation
a) Unless otherwise indicated by the instructions for use of the sphygmomanometer-under-test,
position the subject such that the subject:
1) is comfortable;
EXAMPLE Comfortably seated with legs uncrossed and feet flat on the floor.
2) has the back, elbow and forearm supported;
ISO 81060-2:2018(E)
3) has the measurement site at the level of the left ventricle of the heart.
b) It is recommended that:
1) the subject be as relaxed as possible; and
2) the subject avoids talking during the entire procedure.
c) The cuff shall be applied on the bare arm and there shall be no arm compression proximal to
the cuff.
d) Before the first reference reading is taken, 5 min should elapse.
NOTE Additional details can be found in Reference [16].
Check compliance by inspection of the instructions for use and the clinical investigation report.
5.2.2 * Observer preparation
a) Observers shall be trained in using a proper methodology for performing a resting blood
pressure reading by utilizing an accepted clinical protocol for blood pressure measurement.
References [15], [16], and [25] contain additional information.
b) Observers shall have sufficient practice in performing blood pressure readings.
c) Each observer's recording of observations of the reference sphygmomanometer shall not be
visible to the other observer.
d) The determinations of the sphygmomanometer-under-test shall not be visible to either of these
observers.
EXAMPLE 1 Utilizing a third observer for recording the determinations of the sphygmomanometer-
under-test.
EXAMPLE 2 Utilizing an electronic means for recording the determinations of the sphygmomanometer-
under-test.
e) The Korotkoff sound [fifth phase (K5)] shall be used by the observers for determining the
reference diastolic blood pressure.
f) If the Korotkoff sound [fifth phase (K5)] for determining reference diastolic blood pressure is
not audible, the subject shall be excluded.
Check compliance by inspection of the clinical investigation report.
5.2.3 * Reference readings
a) Two observers shall simultaneously determine the systolic blood pressure and diastolic blood
pressure on each subject using a double stethoscope.
b) Unless the sphygmomanometer-under-test is intended for use during significantly irregular
heart rhythm, if either observer detects significantly irregular heart rhythm, that reading shall be
excluded.
EXAMPLE Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation.
NOTE 1 Although clinical investigation of blood pressure in patients with atrial fibrillation is
clinically important, there are currently no generally accepted guidelines for determining the blood
pressure in such individuals.
c) Any pair of observers' systolic blood pressure value or diastolic blood pressure value with
a difference greater than 4 mmHg (0,53 kPa) shall be excluded.
6 © ISO 2018 – All rights reserved

ISO 81060-2:2018(E)
d) The observers' individual values of each reading shall be averaged according to Formula (1) to
create the reference blood pressure value.
pp+
REFREF
ii,,12
p = (1)
REF
i
where
th
is the blood pressure determined by observer 1 for the i reading;
p
REF
i,1
th
is the blood pressure determined by observer 2 for the i reading;
p
REF
i,2
th
p
is the reference blood pressure value for the i reading.
REF
i
e) The observer-to-observer differences shall be reviewed after completing a set of pairs of test-
reference values.
1) If any readings are excluded, additional pair(s) of readings shall be taken to ensure that the
required number of valid test-reference pairs are available.
2) A maximum of eight pairs of readings per subject shall be taken.
f) Use a reference sphygmomanometer that complies with the requirements of ISO 81060-1, except
that the maximum permissible error shall be ±1 mmHg (0,13 kPa).
1) Reading of the values on the reference sphygmomanometer should be as accurate as possible.
2) When reading the value on the reference sphygmomanometer, the observers should avoid
parallax errors and rounding.
NOTE 2 Rounding has a negative effect on the results of the clinical investigation.
g) Measurement of the upper arm circumference:
1) The upper arm midpoint is first determined by marking the arm posteriorly at a point halfway
between the acromion and olecranon, measured while the arm is flexed 90 degrees at the
elbow with the palm facing up.
2) The subject's upper arm circumference shall be determined by measuring at the midpoint of
the upper arm while the elbow is relaxed and the arm is dangling freely to the side.
h) *Cuffs for the reference sphygmomanometer shall have:
1) a bladder length of 75 % to 100 % of the upper arm circumference; and
2) a bladder width of 37 % to 50 % of the upper arm circumference.
Check compliance by inspection of the clinical investigation report.
5.2.4 Clinical investigation methods
5.2.4.1 Same arm sequential method
5.2.4.1.1 * Procedure
a) Either arm may be utilized.
ISO 81060-2:2018(E)
Perform the following:
b) Using the reference sphygmomanometer, have the observers determine the subject's blood pressure
(see Figure 1).
c) Interchange cuffs and wait at least 60 s.
d) Use the sphygmomanometer-under-test to determine the subject's blood pressure.
e) Clear the sphygmomanometer-under-test memory of the previous determination and then wait at
least 60 s.
EXAMPLES Switching the power off and on, removing the blood pressure module and reinstalling it or issuing a
reset command are methods to clear the memory of the previous determination.
Key
1 double stethoscope
2 reference sphygmomanometer display
3 reference sphygmomanometer hand pump
4 sphygmomanometer-under-test
NOTE Only one cuff is connected to the sphygmomanometer-under-test.
Figure 1 — Illustration of the same arm sequential method
f) Do not use the data points obtained in b) and d) in the calculation of accuracy.
g) Using the reference sphygmomanometer, have the observers determine the subject's blood pressure.
h) Interchange cuffs and wait at least 60 s.
i) Use the sphygmomanometer-under-test to determine the subject's blood pressure.
j) Interchange cuffs and wait at least 60 s.
k) Have the observers use the reference sphygmomanometer to determine the subject's blood pressure
reference reading.
l) Interchange cuffs and wait at least 60 s.
8 © ISO 2018 – All rig
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