SIST EN ISO 81060-2:2020
(Main)Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
This Standard 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). 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.
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden automatisierten Bauart (ISO 81060-2:2018)
Dieses Dokument legt Anforderungen und Verfahren der KLINISCHEN PRÜFUNG für ME GERÄTE (Medizinisches Elektrisches Gerät) fest, die zur INTERMITTIERENDEN nichtinvasiven automatischen Schätzung des arteriellen BLUTDRUCKS unter Verwendung einer MANSCHETTE eingesetzt werden.
Dieses Dokument ist anwendbar auf alle NICHTINVASIVEN BLUTDRUCKMESSGERÄTE, die zur Schätzung, Anzeige oder Aufnahme des BLUTDRUCKS Pulsationen, Fluss oder Geräusche detektieren oder anzeigen. Diese NICHTINVASIVEN BLUTDRUCKMESSGERÄTE brauchen die MANSCHETTE nicht unbedingt automatisch aufpumpen zu können.
Dieses Dokument behandelt NICHTINVASIVE BLUTDRUCKMESSGERÄTE, die für alle PATIENTEN Gruppen (z. B. alle Alters und Gewichtsbereiche) und alle Anwendungsbedingungen (z. B. für die ambulante Langzeit¬BLUTDRUCK¬überwachung, BLUTDRUCKüberwachung unter Belastung und BLUTDRUCKselbstmessung bei der MEDIZINISCHEN VERSORGUNG IN HÄUSLICHER UMGEBUNG sowie für die Nutzung in einer professionellen Gesundheitseinrichtung) geeignet sind.
BEISPIEL AUTOMATISIERTES NICHTINVASIVES BLUTDRUCKMESSGERÄT wie in IEC 80601 2 30 beschrieben, KLINISCH GEPRÜFT nach diesem Dokument.
Dieses Dokument legt zusätzliche Anforderungen für die Beschreibung in den BEGLEITPAPIEREN von NICHTINVASIVEN BLUTDRUCKMESSGERÄTEN fest, die erfolgreich nach diesem Dokument KLINISCH GEPRÜFT sind.
Dieses Dokument ist nicht anwendbar für die KLINISCHE PRÜFUNG der NICHTAUTOMATISIERTEN NICHTINVASIVEN BLUTDRUCKMESSGERÄTE beschrieben in ISO 81060 1 oder des INVASIVEN BLUTDRUCKÜBERWACHUNGSGERÄTS beschrieben in IEC 60601 2 34.
Sphygmomanomètres non invasifs - Partie 2: Investigation clinique pour type ponctuel à mesurage automatique (ISO 81060-2:2018)
Le présent document précise les exigences et les méthodes d'investigation clinique des appareils électromédicaux utilisés pour estimer ponctuellement, de manière non invasive et automatique, la pression artérielle au moyen d'un brassard.
Le présent document est applicable à tous les sphygmomanomètres qui captent ou affichent des pulsations, des flux ou des sons pour l'estimation, l'affichage ou l'enregistrement de la pression artérielle. Il n'est pas nécessaire que ces sphygmomanomètres aient un dispositif de gonflage automatique du brassard.
Le présent document couvre les sphygmomanomètres utilisables pour toutes les populations de patients (par exemple: toutes les tranches d'âge et gammes de poids) et dans toutes les conditions d'emploi (par exemple: contrôle ambulatoire de la pression artérielle, contrôle de la pression artérielle lors d'épreuves d'effort, auto-contrôle de la pression artérielle en environnement de soins à domicile et contrôle de la pression artérielle dans un établissement de soins de santé).
EXEMPLE Sphygmomanomètre automatique tel que défini dans l'IEC 80601‑2‑30 faisant l'objet d'une investigation clinique conformément au présent document.
Le présent document spécifie des exigences supplémentaires de divulgation d'informations pour les documents d'accompagnement des sphygmomanomètres ayant subi avec succès une investigation clinique conformément au présent document.
Le présent document n'est pas applicable à l'investigation clinique des sphygmomanomètres non automatiques tels que définis dans l'ISO 81060‑1 ou des appareils de surveillance de la pression sanguine prélevée directement tels que définis dans l'IEC 60601‑2‑34.
Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja s prekinitvami (ISO 81060-2:2018)
Ta standard določa zahteve in metode za klinične raziskave medicinske električne opreme, ki se uporablja za občasno neinvazivno avtomatizirano oceno arterijskega krvnega tlaka z uporabo manšete. Ta dokument se uporablja za vse sfigmomanometre, ki zaznajo ali prikazujejo utripanje, pretok ali zvoke za oceno, prikaz ali beleženje krvnega tlaka. Ni nujno, da ti sfigmomanometri vključujejo avtomatizirano polnjenje manšet. Ta dokument zajema sfigmomanometre, namenjene za uporabo pri vseh pacientih (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 samomerjenje na domu ter uporaba v strokovni zdravstveni ustanovi). Ta dokument določa dodatne zahteve glede razkrivanja za vse spremne dokumente sfigmomanometrov, ki so prestali klinične raziskave v skladu s tem dokumentom. Ta dokument se ne uporablja za klinične raziskave neavtomatiziranih sfigmomanometrov, kot je opredeljeno v standardu ISO 81060-1, ali za opremo za invazivno nadzorovanje krvnega tlaka, kot je opredeljeno v standardu IEC 60601-2-34.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 81060-2:2020
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
SIST EN ISO 81060-2:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 81060-2:2020
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SIST EN ISO 81060-2:2020
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.
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SIST EN ISO 81060-2:2020
EN ISO 81060-2:2019 (E)
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
2
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SIST EN ISO 81060-2:2020
EN ISO 81060-2:2019 (E)
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
3
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SIST EN ISO 81060-2:2020
EN ISO 81060-2:2019 (E)
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.
4
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SIST EN ISO 81060-2:2020
EN ISO 81060-2:2019 (E)
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.
5
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SIST EN ISO 81060-2:2020
EN ISO 81060-2:2019 (E)
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.
6
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SIST EN ISO 81060-2:2020
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
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SIST EN ISO 81060-2:2020
ISO 81060-2:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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
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SIST EN ISO 81060-2:2020
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 2018 – All rights reserved iii
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SIST EN ISO 81060-2:2020
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
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SIST EN ISO 81060-2:2020
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.
© ISO 2018 – All rights reserved v
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SIST EN ISO 81060-2:2020
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SIST EN ISO 81060-2:2020
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 2018 – All rights reserved 1
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SIST EN ISO 81060-2:2020
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 pres
...
SLOVENSKI STANDARD
oSIST prEN ISO 81060-2:2017
01-oktober-2017
1HLQYD]LYQLVILJPRPDQRPHWULGHO .OLQLþQHUD]LVNDYHDYWRPDWL]LUDQLKYUVW
PHUMHQMDVSUHNLQLWYDPL ,62',6
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent
automated measurement type (ISO/DIS 81060-2:2017)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung der intermittierenden
automatisierten Bauart (ISO/DIS 81060-2:2017)
Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type intermittent à
mesurage automatique (ISO/DIS 81060-2:2017)
Ta slovenski standard je istoveten z: prEN ISO 81060-2
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
oSIST prEN ISO 81060-2:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 81060-2:2017
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oSIST prEN ISO 81060-2:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 81060-2
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-07-11 2017-10-02
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
Sphygmomanomètres non invasifs —
Partie 2: Validation clinique pour type intermittent à mesurage automatique
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
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
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BEING ACCEPTABLE FOR INDUSTRIAL,
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STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 81060-2:2017(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 2017
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oSIST prEN ISO 81060-2:2017
ISO/DIS 81060-2:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved
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oSIST prEN ISO 81060-2:2017
ISO/DIS 81060-2:2017(E)
1 Contents Page
2 Foreword . v
3 European Foreword . vi
4 Introduction . vii
5 1 Scope . 1
6 2 Normative references . 1
7 3 Terms and definitions . 2
8 4 General requirements for CLINICAL INVESTIGATIONS. 2
9 4.1 CLINICAL INVESTIGATION methods . 2
10 4.2 Good clinical practice . 3
11 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER . 3
12 5.1 Subject requirements . 3
13 5.1.1 Number . 3
14 5.1.2 Gender distribution . 4
15 5.1.3 Age distribution . 4
16 5.1.4 Limb size distribution . 4
17 5.1.5 BLOOD PRESSURE distribution . 5
18 5.1.6 Special PATIENT populations . 5
19 5.2 CLINICAL INVESTIGATION method with a REFERENCE SPHYGMOMANOMETER . 6
20 5.2.1 Subject preparation . 6
21 5.2.2 Observer preparation . 6
22 5.2.3 REFERENCE readings . 7
23 5.2.4 CLINICAL INVESTIGATION methods . 8
24 5.2.5 Additional requirements for a SPHYGMOMANOMETER intended for use in exercise stress
25 testing environments . 17
26 5.2.6 Additional requirements for a SPHYGMOMANOMETER intended for use in ambulatory
27 monitoring . 18
28 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING
29 EQUIPMENT . 19
30 6.1 PATIENT requirements . 19
31 6.1.1 Number . 19
32 6.1.2 Gender distribution . 19
33 6.1.3 Age distribution . 19
34 6.1.4 Limb size distribution . 20
35 6.1.5 BLOOD PRESSURE distribution . 20
36 6.1.6 Special PATIENT populations . 21
37 6.2 CLINICAL INVESTIGATION methods with REFERENCE INVASIVE BLOOD PRESSURE MONITORING
38 EQUIPMENT . 21
39 6.2.1 REFERENCE measurement . 21
40 6.2.2 Arterial REFERENCE site . 22
41 6.2.3 PROCEDURE . 22
42 6.2.4 Determining the REFERENCE BLOOD PRESSURE . 23
43 6.2.5 Determining the error of the BLOOD PRESSURE measurement . 24
44 6.2.6 Data analysis . 24
45 6.2.7 MEAN ARTERIAL PRESSURE (MAP) . 25
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46 7 Pregnant (including pre-eclamptic) PATIENT populations .25
47 Annex A (informative) Rationale and guidance .27
48 Annex B (informative) Reference to the ESSENTIAL PRINCIPLES .36
49 Annex C (informative) Terminology — alphabetized index of defined terms .37
50 Annex ZA (informative) Relationship between this European Standard and the essential
51 requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .38
52 Bibliography .39
53
54
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55 Foreword
56 ISO (the International Organization for Standardization) is a worldwide federation of national standards
57 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
58 through ISO technical committees. Each member body interested in a subject for which a technical
59 committee has been established has the right to be represented on that committee. International
60 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
61 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
62 electrotechnical standardization.
63 The procedures used to develop this document and those intended for its further maintenance are
64 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
65 different types of ISO documents should be noted. This document was drafted in accordance with the
66 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
67 Attention is drawn to the possibility that some of the elements of this document may be the subject of
68 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
69 patent rights identified during the development of the document will be in the Introduction and/or on
70 the ISO list of patent declarations received (see www.iso.org/patents).
71 Any trade name used in this document is information given for the convenience of users and does not
72 constitute an endorsement.
73 For an explanation on the meaning of ISO specific terms and expressions related to conformity
74 assessment, as well as information about ISO's adherence to the World Trade Organization (WTO)
75 principles in the Technical Barriers to Trade (TBT) see the following URL:
76 www.iso.org/iso/foreword.html.
77 The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
78 Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62,
79 Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
80 This third edition cancels and replaces the second edition (ISO 81060-2:2013), which has been
81 technically revised.
82 The most significant changes are the following modifications:
83 a) Same arm simultaneous method has been deleted;
84 b) numerous clarifications have been added and kPa equivalent values for the mmHg values have been
85 included.
86
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87 European Foreword
88 The following referenced documents are indispensable for the application of this document. For undated
89 references, the latest edition of the referenced document (including any amendments) applies. For dated
90 references, only the edition cited applies. However, for any use of this standard “within the meaning of
91 Annex ZA", the user should always check that any referenced document has not been superseded and that
92 its relevant contents can still be considered the generally acknowledged state-of-art.
93 When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a
94 normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the
95 foreword and the Annexes ZZ.
96 NOTE The way in which these references documents are cited in normative requirements determines the
97 extent (in whole or in part) to which they apply.
98 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
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 80601-2-30:2009+AMD1:2013 EN 80601-2-30:2010 IEC 80601-2-30:2009
+AMD1:2015 +AMD1:2013
ISO 81060-1:2007 EN ISO 81060-1:2012 ISO 81060-1:2007
99
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100 Introduction
101 Determining the BLOOD PRESSURE is an important PROCEDURE that is clinically used to assess the status of a
102 PATIENT.
103 Frequently determining the BLOOD PRESSURE is routine during anaesthesia. BLOOD PRESSURE serves to aid
104 in drug titration and fluid management and to provide warning of conditions that could affect PATIENT
105 morbidity and mortality.
106 In this document, the following print types are used:
107 — requirements, compliance with which can be verified, and definitions: roman type;
108 — notes and examples: smaller roman type;
109 — test methods: italic type;
110 — TERMS DEFINED IN THIS DOCUMENT: SMALL CAPITALS TYPE.
111 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
112 of the conditions is true.
113 The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives,
114 Part 2. For the purposes of this document, the auxiliary verb:
115 — “shall” means that compliance with a requirement or a test is mandatory for compliance with this
116 document;
117 — “should” means that compliance with a requirement or a test is recommended but is not mandatory
118 for compliance with this document;
119 — “may” is used to describe a permissible way to achieve compliance with a requirement or test.
120 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
121 that there is guidance or rationale related to that item in Annex A.
122 Annex B maps the clauses and subclauses of this document with the ESSENTIAL PRINCIPLES of
123 ISO 16142-1:2016
124 The attention of Member Bodies and National Committees is drawn to the fact that equipment
125 manufacturers and testing organizations may need a transitional period following publication of a new,
126 amended or revised ISO or IEC publication in which to make products in accordance with the new
127 requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
128 the committees that the content of this document not be adopted for mandatory implementation
129 nationally earlier than 3 years from the date of publication for equipment newly designed, and not earlier
130 than 5 years from the date of publication for equipment already in production.
131
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132 Non-invasive sphygmomanometers — Part 2: Clinical
133 investigation of the intermittent automated measurement
134 type
135 1 Scope
136 This document specifies the requirements and methods for the CLINICAL INVESTIGATION of ME EQUIPMENT
137 used for the INTERMITTENT non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing
138 a CUFF.
139 This document is applicable to all SPHYGMOMANOMETERS that sense or display pulsations, flow or sounds
140 for the estimation, display or recording of BLOOD PRESSURE. These SPHYGMOMANOMETERS need not have
141 automatic CUFF inflation.
142 This document covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and
143 weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress testing BLOOD
144 PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for self-
145 measurement as well as use in a professional healthcare facility).
146 EXAMPLE AUTOMATED SPHYGMOMANOMETER as given in IEC 80601-2-30 undergoing CLINICAL INVESTIGATION according
147 to this document.
148 This document specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of
149 SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this document.
150 This document is not applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPHYGMOMANOMETERS as
151 given in ISO 81060-1 or INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as given in IEC 60601-2-34.
152 2 Normative references
153 The following documents are referred to in the text in such a way that some or all of their content
154 constitutes requirements of this document. For dated references, only the edition cited applies. For
155 undated references, the latest edition of the referenced document (including any amendments) applies.
156 NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
157 extent (in whole or in part) to which they apply.
158 NOTE 2 Informative references are listed in the bibliography.
159 ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
160 ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-
161 automated measurement type
162 IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
163 essential performance
164 +Amendment 1:2012
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165 IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety
166 and essential performance — Collateral standard: Requirements for medical electrical equipment and
167 medical electrical systems used in home care applications
168 IEC 60601-2-34:2011, Medical electrical equipment — Part 2-34: Particular requirements for the basic
169 safety and essential performance of invasive blood pressure monitoring equipment
170 IEC 80601-2-30:2009, Medical electrical equipment — Part 2-30: Particular requirements for basic safety
171 and essential performance of automated non-invasive sphygmomanometers
172 +Amendment 1:2013
173 3 Terms and definitions
174 For the purposes of this document, the terms and definitions given in ISO 14155:2011, ISO 14971:2007,
175 ISO 16142-1:2016, IEC 80601-2-30:2009+AMD1:2013, IEC 60601-1:2005+AMD1:2012,
176 IEC 60601-1-11:2015, IEC 60601-2-34:2011 and the following apply.
177 ISO and IEC maintain terminological databases for use in standardization at the following addresses:
178 — IEC Electropedia: available at http://www.electropedia.org/
179 — ISO Online browsing platform: available at http://www.iso.org/obp
180 NOTE For convenience, an alphabetized index of defined terms is found in Annex C.
181 3.1
182 INTERMITTENT
183 type of non-invasive SPHYGMOMANOMETER utilizing a PROCESS of estimating BLOOD PRESSURE that
184 provides a single set of pressure values from a number of heart beats
185 3.2
186 REFERENCE
187 REF
188 established accuracy used for the CLINICAL INVESTIGATION of other instruments
189 3.3
190 SPHYGMOMANOMETER
191 ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE
192 3.4
193 SPHYGMOMANOMETER-UNDER-TEST
194 SUT
195 AUTOMATED SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION
196 4 General requirements for CLINICAL INVESTIGATIONS
197 4.1 CLINICAL INVESTIGATION methods
198 a) AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION according to this document in
199 each mode of operation by either using:
200 1) a non-invasive auscultatory REFERENCE SPHYGMOMANOMETER at the upper arm; or
201 2) a REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT.
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202 EXAMPLE 1 Adult and neonatal modes.
203 EXAMPLE 2 Slow and fast CUFF deflation rate modes.
204 b) A CLINICAL INVESTIGATION shall be considered a TYPE TEST.
205 c) An AUTOMATED SPHYGMOMANOMETER intending to display central or aortic BLOOD PRESSURE shall utilize
206 a central or aortic invasive REFERENCE site for CLINICAL INVESTIGATION (see 6.2.2).
207 NOTE Such an AUTOMATED SPHYGMOMANOMETER is investigated according to Clause 6.
208 Consider compliance with the requirements of this subclause to exist when the criteria of the relevant
209 inspections and tests in this document are met.
210 4.2 Good clinical practice
211 a) All CLINICAL INVESTIGATIONS shall comply with the requirements of ISO 14155:2011.
212 b) CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT should not be
213 used for PATIENTS or subjects solely for the purpose of investigating SPHYGMOMANOMETER
214 performance.
215 NOTE Some AUTHORITIES HAVING JURISDICTION have additional requirements.
216 c) The requirements of this document, which are more specific than the corresponding requirements
217 of ISO 14155:2011, shall prevail.
218 Check compliance by application of the requirements of ISO 14155:2011.
219 4.3 Status of previous CLINICAL INVESTIGATIONS
220 The CLINICAL INVESTIGATION results for SPHYGMOMANOMETERS that have been successfully clinically
221 investigated according to previous versions of ISO 81060-2 remain valid and a CLINICAL INVESTIGATION
222 need not be repeated to comply with this document.
223 4.4 Disclosure of summary of CLINICAL INVESTIGATION
224 The technical description of a SPHYGMOMANOMETER shall contain contact information permitting the
225 RESPONSIBLE ORGANIZATION to acquire a copy of the summary of the CLINICAL EVALUATION.
226 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER
227 5.1 Subject requirements
228 5.1.1 * Number
229 a) An auscultatory REFERENCE SPHYGMOMANOMETER CLINICAL INVESTIGATION shall consist of a minimum of
230 85 subjects.
231 b) If not otherwise specified, at least three valid BLOOD PRESSURE values shall be taken for each subject
232 (see 5.2.4.1.1 o) ).
233 c) There shall be a minimum of 255 valid paired BLOOD PRESSURE values.
234 Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
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235 5.1.2 * Gender distribution
236 a) At least 30 % of the subjects shall be male.
237 b) At least 30 % of the subjects shall be female.
238 Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
239 5.1.3 * Age distribution
240 a) For a SPHYGMOMANOMETER intended for use on adults or adolescent PATIENTS, the age of every subject
241 included in the CLINICAL INVESTIGATION shall be greater than 12 years.
242 NOTE 1 Minimum total of 85 subjects.
243 b) For a SPHYGMOMANOMETER additionally intended for use in children, 35 child subjects aged between
244 3 years and 12 years shall be included in the CLINICAL INVESTIGATION.
245 NOTE 2 Minimum total of 85 subjects.
246 c) If the SPHYGMOMANOMETER has a special mode for children, in that mode, children shall be considered
247 a special PATIENT population (see 5.1.6). In such a study, children are exempt from the BLOOD PRESSURE
248 distribution requirements of 5.1.5.
249 d) Children aged less than 3 years shall not be included in a CLINICAL INVESTIGATION utilizing auscultatory
250 readings by observers with a REFERENCE SPHYGMOMANOMETER.
251 Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT.
252 5.1.4 Limb size distribution
253 a) For a SPHYGMOMANOMETER intended for use with a single CUFF size:
254 1) at least 40 % of the subjects shall have a limb circumference which lies within the upper half of
255 the specified range of use of the CUFF;
256 2) at least 40 % of the subjects shall have a limb circumference within the lower half of the specified
257 range of use of the CUFF;
258 3) at least 20 % of the subjects shall have a limb circumference which lies within the upper quarter
259 of the specified range of use of the CUFF;
260 4) at least 20 % of the subjects shall have a limb circumference within the lower quarter of the
261 specified range of use of the CUFF; and
262 5) at least 10 % of the subjects shall have a limb circumference which lies within the upper octal of
263 the specified range of use of the CUFF; and
264 6) at least 10 % of the subjects shall have a limb circumference within the lower octal of the
265 specified range of use of the CUFF.
266 b) For a SPHYGMOMANOMETER intended for use with multiple CUFF sizes:
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267 1) each CUFF size shall be tested on at least of the subjects, where n is the number of CUFF
2× n
268 sizes; and
269 2) at least 40 % of the subjects shall have a limb circumference which lies within the upper half of
270 the specified range of use of the CUFF; and
271 3) at least 40 % of the subjects shall have a limb circumference within the lower half of the specified
272 range of use of the CUFF.
273 Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT.
274 5.1.5 BLOOD PRESSURE distribution
275 a) At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE
276 ≤ 100 mmHg (13,33 kPa).
277 b) At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE
278 ≥ 160 mmHg (21,33 kPa).
279 c) At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE
280 ≥ 140 mmHg (18,66 kPa).
281 d) At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE
282 ≤ 60 mmHg (8,0 kPa).
283 e) At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE
284 ≥ 100 mmHg (13,33 kPa).
285 f) At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE
286 ≥ 85 mmHg (11,33 kPa).
287 Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
288 5.1.6 * Special PATIENT populations
289 a) A SPHYGMOMANOMETER that is intended for use in special PATIENT populations where there is OBJECTIVE
290 EVIDENCE that the accuracy of the SPHYGMOMANOMETER might be problematic in those PATIENT
291 populations, shall undergo CLINICAL INVESTIGATION in those PATIENT populations.
292 NOTE Clause 7 has a specific example of a special PATIENT population with specific requirements.
293 b) If the SPHYGMOMANOMETER has undergone CLINICAL INVESTIGATION according to the requirements of
294 5.1.1 and 5.2, it shall then undergo CLINICAL INVESTIGATION in at least an additional 35 special
295 population subjects.
296 c) If the SPHYGMOMANOMETER has not pr
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