EN ISO 81060-2:2019
(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 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.
This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.
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.
Le présent document n’est pas applicable à l’INVESTIGATION CLINIQUE d’un ensemble de BRASSARDS dont les matériaux et la construction ne sont pas identiques. Il est nécessaire d’évaluer séparément chaque type d’ensemble de BRASSARDS conformément au présent document.
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
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 .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.