SIST EN ISO 81060-2:2014

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)

EN ISO 81060-3 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 part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060. This part of ISO 81060 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 von Geräten der automatisierten Bauart (ISO 81060-2:2013)

Dieser Teil der ISO 81060 legt Anforderungen und Verfahren der klinischen Prüfung für ME-GERÄTEN fest, die zur nichtkontinuierlichen nichtinvasiven automatischen Schätzung des arteriellen Blutdrucks unter Verwendung einer MANSCHETTE eingesetzt werden.
Dieser Teil der ISO 81060 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 können.
Dieser Teil der ISO 81060 behandelt NICHTINVASIVE BLUTDRUCKMESSGERÄTE, die für alle PATIENTEN-Gruppen (z.B. alle Alters- und Gewichtsbereiche) und alle Anwendungsbedingungen geeignet sind (z.B. für die ambulante Langzeitblutdrucküberwachung, BLUTDRUCK-Überwachung unter Belastung und BLUTDRUCK-Selbstmessung bei der MEDIZINISCHEN VERSORGUNG IN HÄUSLICHER UMGEBUNG sowie für die Nutzung in einer professionellen Gesundheitseinrichtung).
BEISPIEL   AUTOMATISIERTES NICHTINVASIVES BLUTDRUCKMESSGERÄT wie in ISO IEC 80601-2-30 beschrieben, klinisch geprüft nach diesem Teil der ISO 81060.
Dieser Teil der ISO 81060 legt zusätzliche Anforderungen für die Beschreibung in den BEGLEITPAPIEREN von NICHTINVASIVEN BLUTDRUCKMESSGERÄTEN, klinisch geprüft nach diesem Teil der ISO 81060, fest.
Dieser Teil der ISO 81060 ist nicht anwendbar zur klinischen Prüfung der NICHTAUTOMATISIERTEN NICHTINVASIVEN BLUTDRUCKMESSGERÄTE beschrieben in IEC ISO 81060-1 oder INVASIVE BLUTDRUCKMESSGERÄTE beschrieben in IEC 60601-2-34.

Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage automatique (ISO 81060-2:2013)

L'ISO 81060-2:2013 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.
L'ISO 81060-2:2013 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.
L'ISO 81060-2:2013 couvre les sphygmomanomètres utilisables pour toutes les populations de patients et dans toutes les conditions d'emploi.
L'ISO 81060-2:2013 spécifie des exigences supplémentaires de divulgation d'informations pour les documents d'accompagnement des sphygmomanomètres ayant fait l'objet d'une investigation clinique conformément à la'ISO 81060-2:2013.

Neinvazivni sfigmomanometri - 2. del: Klinične raziskave avtomatiziranih vrst merjenja (ISO 81060-2:2013)

Standard EN ISO 81060-3 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 del standarda ISO 81060 se uporablja za vse SFIGMOMANOMETRE, ki zaznajo ali prikazujejo utripanje, pretok ali zvoke za oceno, prikaz ali beleženje KRVNEGA TLAKA. Ti SFIGMOMANOMETRI ne potrebujejo avtomatiziranega polnjenja MANŠET. Ta del standarda ISO 81060 zajema SFIGMOMANOMETRE, namenjene uporabi za vse PACIENTE (npr. ne glede na starost in težo) in pri vseh pogojih uporabe (npr. ambulantno nadzorovanje KRVNEGA TLAKA, nadzorovanje KRVNEGA TLAKA s stresnim testom in monitorji KRVNEGA TLAKA za OKOLJE DOMAČE ZDRAVSTVENE OSKRBE za samomerjenje ter uporaba v strokovni zdravstveni ustanovi). Ta del standarda ISO 81060 določa dodatne zahteve glede razkrivanja za vse SPREMNE DOKUMENTE SFIGMOMANOMETROV, ki so prestali KLINIČNE RAZISKAVE v skladu s tem delom standarda ISO 81060. Ta del standarda ISO 81060 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

• Status: Withdrawn
• Public Enquiry End Date: 14-Jan-2014
• Publication Date: 18-Aug-2014
• Withdrawal Date: 12-Jan-2020
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Jan-2020
• Due Date: 05-Feb-2020
• Completion Date: 13-Jan-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 81060-2:2014 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)

Relations

• Replaced By: SIST EN ISO 81060-2:2020 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
• Effective Date: 01-Feb-2019
• Replaces: SIST EN 1060-4:2005 - Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
• Effective Date: 01-Sep-2014

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung von Geräten der automatisierten Bauart (ISO 81060-2:2013)Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage automatique (ISO 81060-2:2013)Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 81060-2:2014SIST EN ISO 81060-2:2014en01-september-2014SIST EN ISO 81060-2:2014SLOVENSKI
STANDARDSIST EN 1060-4:20051DGRPHãþD



SIST EN ISO 81060-2:2014



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 81060-2
April 2014 ICS 11.040.10 Supersedes EN 1060-4:2004English Version
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage automatique (ISO 81060-2:2013)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung von Geräten der automatisierten Bauart (ISO 81060-2:2013) This European Standard was approved by CEN on 18 April 2014.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 81060-2:2014 ESIST EN ISO 81060-2:2014



EN ISO 81060-2:2014 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4
SIST EN ISO 81060-2:2014



EN ISO 81060-2:2014 (E) 3 Foreword The text of ISO 81060-2:2013 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Electromedical equipment” of the International Electrotechnical Commission (IEC) and has been taken over as EN ISO 81060-2:2014 by 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 October 2014, and conflicting national standards shall be withdrawn at the latest by April 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1060-4:2004. EN ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers: — Part 1: Requirements and test methods for non-automated measurement type — Part 2: Clinical validation of automated measurement type EN 80601-2-30, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, is a related standard. 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 relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 81060-2:2013 has been approved by CEN as EN ISO 81060-2:2014 without any modification. SIST EN ISO 81060-2:2014



EN ISO 81060-2:2014 (E) 4 Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the 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. Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 to 6 10.1 Only the characteristics of the measurement performance (accuracy), as well as the corresponding tests methods, are addressed. 5.1.6, 5.2.2, 6.2.1, 6.2.2, 6.2.7, 7 13.6 Only additional warnings and precautions specific to particular situations and subjects populations are addressed. 4.2 Annex X, 2.2 Normative reference to EN ISO 14155 in its entirety. 5 to 7 Annex X, 2.3.1 to 2.3.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
SIST EN ISO 81060-2:2014



Reference numberISO 81060-2:2013(E)© ISO 2013
INTERNATIONAL STANDARD ISO81060-2Second edition2013-05-01Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type Sphygmomanomètres non invasifs — Partie 2: Validation clinique pour type à mesurage automatique
SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E)
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ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56  CH-1211 Geneva 20 Tel.
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ii © ISO 2013 – All rights reserved
SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) © ISO 2013 – All rights reserved
iii Contents Page 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 2 4 General requirements for CLINICAL INVESTIGATIONS . 2 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER . 3 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 17 7 * Pregnant (including pre-eclamptic) PATIENT populations . 22 Annex A (informative)
Rationale and guidance . 23 Annex B (normative)
Target heart rates for exercise stress testing . 35 Annex C (informative)
Reference to the essential principles . 36
SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) iv
© ISO 2013 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. This second edition cancels and replaces the first edition (ISO 81060-2:2009), subclauses 5.2.4.3.1 and 6.2.4 of which have been technically revised. Numerous clarifications have been added and kPa equivalent values for the mmHg values have been included in the standard, including the Criterion 2 requirements of 5.2.4.1.2. It also incorporates the Technical Corrigendum ISO 81060-2:2009/Cor 1:2011. ISO 81060-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in collaboration with Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee 62D, Electromedical equipment, in accordance with ISO/IEC mode of cooperation 5. ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers:  Part 1: Requirements and test methods for non-automated measurement type  Part 2: Clinical investigation of automated measurement type In this document, the following print types are used:  requirements, compliance with which can be verified, and definitions: roman type;  notes and examples: smaller roman type;  test methods: italic type;
 terms defined in this document: SMALL CAPITALS TYPE. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of ISO/TC 121 and IEC/TC 62 that the content of this part of ISO 81060 not be adopted for mandatory implementation nationally earlier than 3 years from the date of publication for equipment newly designed, and not earlier than 5 years from the date of publication for equipment already in production. SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) © ISO 2013 – All rights reserved
v Introduction Determination of BLOOD PRESSURE is an important procedure that is clinically used to assess the status of a PATIENT. Frequent determination of BLOOD PRESSURE is routine during anaesthesia. BLOOD PRESSURE serves to aid in drug titration and fluid management and to provide warning of conditions that could affect PATIENT morbidity and mortality.
SIST EN ISO 81060-2:2014



SIST EN ISO 81060-2:2014



INTERNATIONAL STANDARD ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 1 Non-invasive sphygmomanometers — Part 2: Clinical investigation of the automated measurement type 1 Scope This part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060. This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060. This part of ISO 81060 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, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 81060-1, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type IEC 80601-2-30:2009, Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance Amendment 1:2012 SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) 2 © ISO 2013 – All rights reserved IEC 60601-1-11:2010, 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 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14155, IEC 80601-2-30, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-34 and the following apply.
NOTE For convenience, an alphabetized index of defined terms is found beginning on page 40. 3.1 REFERENCE, adj established accuracy used for the CLINICAL INVESTIGATION of other instruments 3.2 SPHYGMOMANOMETER ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE 3.3 SPHYGMOMANOMETER-UNDER-TEST SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION 4 General requirements for CLINICAL INVESTIGATIONS 4.1 CLINICAL INVESTIGATION methods SPHYGMOMANOMETERS other than NON-AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION either by using a non-invasive (auscultatory) REFERENCE SPHYGMOMANOMETER or by using REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT according to this part of ISO 81060 in each mode of operation. EXAMPLE 1 Adult and neonatal modes. EXAMPLE 2 Slow and fast CUFF deflation rate modes. A CLINICAL INVESTIGATION shall be considered a TYPE TEST. Consider compliance with the requirements of this subclause to exist when the criteria of the relevant inspections and tests in this part of ISO 81060 are met. 4.2 Good clinical practice All CLINICAL INVESTIGATIONS shall comply with the requirements of ISO 14155. 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. The requirements of this International Standard, which are more specific than the corresponding requirements of ISO 14155, shall prevail.
Check compliance by application of the requirements of ISO 14155. SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 3 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER 5.1 Subject requirements 5.1.1 * Number An auscultatory REFERENCE SPHYGMOMANOMETER CLINICAL INVESTIGATION shall consist of a minimum of 85 subjects. If not otherwise specified, at least three valid BLOOD PRESSURE DETERMINATIONS shall be taken for each subject. There shall be a minimum of 255 valid paired BLOOD PRESSURE DETERMINATIONS. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.2 * Gender distribution At least 30 % of the subjects shall be male and at least 30 % of the subjects shall be female. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.3 * Age distribution For a SPHYGMOMANOMETER intended for use on adults and/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. 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. 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. Children aged less than 3 years shall not be included in a CLINICAL INVESTIGATION utilizing auscultatory DETERMINATIONS 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 For a SPHYGMOMANOMETER intended for use with a single CUFF size:  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 at least 40 % shall have a limb circumference within the lower half; and  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 and at least 20 % shall have a limb circumference within the lower quarter. For a SPHYGMOMANOMETER intended for use with multiple CUFF sizes, each CUFF size shall be tested on at least 12n of the subjects, where nis the number of CUFF sizes. Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT. SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) 4 © ISO 2013 – All rights reserved 5.1.5 * BLOOD PRESSURE distribution At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≤ 100 mmHg (13,33 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≥ 160 mmHg (21,33 kPa). At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≥ 140 mmHg (18,66 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≤ 60 mmHg (8,0 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≥ 100 mmHg (13,33 kPa). 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 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. If the SPHYGMOMANOMETER has undergone 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. If the SPHYGMOMANOMETER has not previously 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. The special PATIENT population shall be defined in clear terms and address the following attributes: gender (see 5.1.2), age (see 5.1.3), limb size (see 5.1.4) and BLOOD PRESSURE (see 5.1.5). A summary of this 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 Unless otherwise indicated by the instructions for use of the SPHYGMOMANOMETER-UNDER-TEST, position the subject such that the subject:  is comfortable; EXAMPLE Comfortably seated with legs uncrossed and feet flat on the floor.  has the back, elbow and forearm supported;  has the middle of the CUFF at the level of the right atrium of the heart. SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 5 Recommend that the subject be as relaxed as possible and that the subject avoid talking during the entire procedure. Before the first reading is taken, 5 min should elapse. NOTE Additional details can be found in Reference [32]. 5.2.2 * Observer preparation Observers should be trained in using a proper methodology for performing a resting BLOOD PRESSURE DETERMINATION by utilizing an accepted clinical protocol for BLOOD PRESSURE measurement. References [8], [28], [29], [32] and [45] contain additional information. Observers should have sufficient practice in performing BLOOD PRESSURE DETERMINATIONS. Each observer's recording of observations of the REFERENCE SPHYGMOMANOMETER shall not be visible to the other observer. The readings of the SPHYGMOMANOMETER-UNDER-TEST shall not be visible to either of these observers. EXAMPLE 1 Utilizing a third observer for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST. EXAMPLE 2 Utilizing an electronic means for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST. Instruct the observers to determine the DIASTOLIC BLOOD PRESSURE as the last audible Korotkoff sound (fifth phase or K5), except when Korotkoff sounds are still audible with the CUFF deflated or in children between 3 years and 12 years of age, where the fourth phase (K4) is used. If K4 is not audible in a child, either K5 is used or the subject is excluded. NOTE Other than for children, K4 should be reserved for subjects in whom there is a large discrepancy between muffling and disappearance (with the latter at times approaching zero mmHg). Instruct the observers to record which Korotkoff sound has been used for the DETERMINATION of DIASTOLIC BLOOD PRESSURE. The Korotkoff sound used for DETERMINATION of DIASTOLIC BLOOD PRESSURE in the CLINICAL INVESTIGATION shall be disclosed in the instructions for use of a SPHYGMOMANOMETER. EXAMPLE 3 K5 was used on 65 subjects and K4 was used on 20 subjects. 5.2.3 * REFERENCE DETERMINATION Two observers shall make simultaneous BLOOD PRESSURE DETERMINATIONS on each subject using a double stethoscope. Unless the SPHYGMOMANOMETER-UNDER-TEST is intended for use during significantly irregular heart rhythm and if either observer detects significantly irregular heart rhythm, that DETERMINATION shall be excluded. EXAMPLES 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. Any pair of observers' DETERMINATIONS with a difference greater than 4 mmHg (0,53 kPa) shall be excluded. The observers' individual values of each DETERMINATION shall be averaged according to Formula (1) to create the REFERENCE BLOOD PRESSURE DETERMINATION. ,1,2refrefref2iiippp (1) where ,1refip is the BLOOD PRESSURE determined by observer 1 for the ith DETERMINATION; SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) 6 © ISO 2013 – All rights reserved ,2refip is the BLOOD PRESSURE determined by observer 2 for the ith DETERMINATION; refip is the REFERENCE BLOOD PRESSURE for the ith DETERMINATION. The observer-to-observer differences shall be reviewed after completing a set of pairs of test-REFERENCE DETERMINATIONS. If any DETERMINATIONS are excluded, additional pair(s) of DETERMINATIONS shall be taken to ensure that the required number of valid test-REFERENCE pairs are available. A maximum of eight pairs of DETERMINATIONS should be taken. 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). Reading of the values on the REFERENCE SPHYGMOMANOMETER should be as accurate as possible. 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. NOTE 3 For the purposes of this part of ISO 81060, the CUFF is considered part of the REFERENCE SPHYGMOMANOMETER. A CUFF that does not comply with ISO 81060-1 cannot be used. 5.2.4 CLINICAL INVESTIGATION methods 5.2.4.1 Same arm simultaneous method 5.2.4.1.1 * Procedure This method shall only be used with a SPHYGMOMANOMETER-UNDER-TEST:  that has a CUFF compliant with ISO 81060-1;  that is designed for use on the upper arm; and  where  the continuous linear deflation rate is between 2 mmHg/s (0,27 kPa/s) and 3 mmHg/s (0,40 kPa/s) or  for a SPHYGMOMANOMETER-UNDER-TEST that controls the deflation as a function of the pulse rate, the deflation rate is between 2 mmHg/pulse (0,27 kPa/pulse) and 3 mmHg/pulse (0,40 kPa/pulse). Either arm may be utilized.
The SPHYGMOMANOMETER-UNDER-TEST shall not deflate prior to the detection of the REFERENCE DIASTOLIC BLOOD PRESSURE. The SPHYGMOMANOMETER-UNDER-TEST may be modified to meet this criterion. NOTE Valid same arm simultaneous DETERMINATIONS require the SPHYGMOMANOMETER-UNDER-TEST to inflate the CUFF to at least 20 mmHg (2,67 kPa) higher than the actual SYSTOLIC BLOOD PRESSURE, as determined by the REFERENCE SPHYGMOMANOMETER, and to at least 20 mmHg (2,67 kPa) below the actual DIASTOLIC BLOOD PRESSURE, as determined by the REFERENCE SPHYGMOMANOMETER. Perform the following: a) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE utilizing the same CUFF and inflation/deflation cycle (see Figure 1). These data points are not used in the calculation of accuracy of the SPHYGMOMANOMETER-UNDER-TEST. b) Clear the SPHYGMOMANOMETER-UNDER-TEST memory of the previous DETERMINATION and then wait at least 60 s. SIST EN ISO 81060-2:2014



ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 7 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. c) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE utilizing the same CUFF and inflation/deflation cycle. d) Wait at least 60 s between DETERMINATIONS. e) Repeat c) and d) until the required number of valid DETERMINATIONS has been performed. All data from a subject shall be excluded if any two REFERENCE SYSTOLIC BLOOD PRESSURE DETERMINATIONS differ by more than 12 mmHg (1,60 kPa) or if any two REFERENCE DIASTOLIC BLOOD PRESSURE DETERMINATIONS differ by more than 8 mmHg (1,07 kPa).
Key 1 double stethoscope 2 REFERENCE SPHYGMOMANOMETER display 3 SPHYGMOMANOMETER-UNDER-TEST Figure 1 — Illustration of same arm simultaneous method 5.2.4.1.2 * Data ana
...

SLOVENSKI STANDARD
kSIST FprEN ISO 81060-2:2013
01-december-2013
1HLQYD]LYQLVILJPRPDQRPHWULGHO.OLQLþQHUD]LVNDYHDYWRPDWL]LUDQLKYUVW
PHUMHQMD,62
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated
measurement type (ISO 81060-2:2013)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung von Geräten der
automatisierten Bauart (ISO 81060-2:2013)
Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage
automatique (ISO 81060-2:2013)
Ta slovenski standard je istoveten z: FprEN ISO 81060-2
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
kSIST FprEN ISO 81060-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST FprEN ISO 81060-2:2013

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kSIST FprEN ISO 81060-2:2013


EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 81060-2
NORME EUROPÉENNE

EUROPÄISCHE NORM

October 2013
ICS 11.040.55
English Version
Non-invasive sphygmomanometers - Part 2: Clinical
investigation of automated measurement type (ISO 81060-
2:2013)
Sphygmomanomètres non invasifs - Partie 2: Validation Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische
clinique pour type à mesurage automatique (ISO 81060- Prüfung von Geräten der automatisierten Bauart (ISO
2:2013) 81060-2:2013)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 205.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 81060-2:2013: E
worldwide for CEN national Members.

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kSIST FprEN ISO 81060-2:2013
FprEN ISO 81060-2:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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kSIST FprEN ISO 81060-2:2013
FprEN ISO 81060-2:2013 (E)
Foreword
The text of ISO 81060-2:2013 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic
and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee
IEC/SC 62D “Electromedical equipment” of the International Electrotechnical Commission (IEC) and has been
taken over as FprEN ISO 81060-2:2013 by Technical Committee CEN/TC 205 “Non-active medical devices”
the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN 1060-1:1995+A1:2009, EN 1060-3:1997+A2:2009, EN 1060-4:2004,
EN 60601-2-30:2000.
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 relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
EN ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers:
 Part 1: Requirements and test methods for non-automated measurement type
 Part 2: Clinical validation of automated measurement type
EN 80601-2-30, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers, is a related standard.
Endorsement notice
The text of ISO 81060-2:2013 has been approved by CEN as FprEN ISO 81060-2:2013 without any
modification.



3

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kSIST FprEN ISO 81060-2:2013
FprEN ISO 81060-2:2013 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
EN Directive 93/42/EEC
4 to 6 10.1 Only the characteristics of the
measurement performance
(accuracy), as well as the
corresponding tests methods, are
addressed.
5.1.6, 5.2.2, 6.2.1, 6.2.2, 6.2.7, 7 13.6 Only additional warnings and
precautions specific to particular
situations and subjects
populations are addressed.
4.2 Annex X, 2.2 Normative reference to
EN ISO 14155 in its entirety.
5 to 7 Annex X, 2.3.1 to 2.3.3

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4

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kSIST FprEN ISO 81060-2:2013

INTERNATIONAL ISO
STANDARD 81060-2
Second edition
2013-05-01


Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of automated
measurement type
Sphygmomanomètres non invasifs —
Partie 2: Validation clinique pour type à mesurage automatique




Reference number
ISO 81060-2:2013(E)
©
ISO 2013

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)

COPYRIGHT PROTECTED DOCUMENT


©  ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2013 – All rights reserved

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
Contents Page
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  General requirements for CLINICAL INVESTIGATIONS . 2
5  CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER . 3
6  CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 17
7  * Pregnant (including pre-eclamptic) PATIENT populations . 22
Annex A (informative) Rationale and guidance . 23
Annex B (normative) Target heart rates for exercise stress testing . 35
Annex C (informative) Reference to the essential principles . 36

© ISO 2013 – All rights reserved iii

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
This second edition cancels and replaces the first edition (ISO 81060-2:2009), subclauses 5.2.4.3.1 and 6.2.4
of which have been technically revised. Numerous clarifications have been added and kPa equivalent values
for the mmHg values have been included in the standard, including the Criterion 2 requirements of 5.2.4.1.2. It
also incorporates the Technical Corrigendum ISO 81060-2:2009/Cor 1:2011.
ISO 81060-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, in collaboration with Technical Committee
IEC/TC 62, Electrical equipment in medical practice, Subcommittee 62D, Electromedical equipment, in
accordance with ISO/IEC mode of cooperation 5.
ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers:
 Part 1: Requirements and test methods for non-automated measurement type
 Part 2: Clinical investigation of automated measurement type
In this document, the following print types are used:
 requirements, compliance with which can be verified, and definitions: roman type;
 notes and examples: smaller roman type;
 test methods: italic type;
 terms defined in this document: SMALL CAPITALS TYPE.
Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of ISO/TC 121 and IEC/TC 62 that
the content of this part of ISO 81060 not be adopted for mandatory implementation nationally earlier than 3
years from the date of publication for equipment newly designed, and not earlier than 5 years from the date of
publication for equipment already in production.
iv © ISO 2013 – All rights reserved

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
Introduction
Determination of BLOOD PRESSURE is an important procedure that is clinically used to assess the status of a
PATIENT.
Frequent determination of BLOOD PRESSURE is routine during anaesthesia. BLOOD PRESSURE serves to aid in
drug titration and fluid management and to provide warning of conditions that could affect PATIENT morbidity
and mortality.

© ISO 2013 – All rights reserved v

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kSIST FprEN ISO 81060-2:2013

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kSIST FprEN ISO 81060-2:2013
INTERNATIONAL STANDARD ISO 81060-2:2013(E)

Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of the automated measurement type
1 Scope
This part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060.
This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of
SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060.
This part of ISO 81060 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, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 81060-1, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-
automated measurement type
IEC 80601-2-30:2009, Medical electrical equipment — Part 2-30: Particular requirements for basic safety and
essential performance of automated non-invasive sphygmomanometers
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
Amendment 1:2012
© ISO 2013 – All rights reserved 1

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
IEC 60601-1-11:2010, 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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14155, IEC 80601-2-30,
IEC 60601-1, IEC 60601-1-11, IEC 60601-2-34 and the following apply.
NOTE For convenience, an alphabetized index of defined terms is found beginning on page 40.
3.1
REFERENCE, adj
established accuracy used for the CLINICAL INVESTIGATION of other instruments
3.2
SPHYGMOMANOMETER
ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE
3.3
SPHYGMOMANOMETER-UNDER-TEST
SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION
4 General requirements for CLINICAL INVESTIGATIONS
4.1 CLINICAL INVESTIGATION methods
SPHYGMOMANOMETERS other than NON-AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION
either by using a non-invasive (auscultatory) REFERENCE SPHYGMOMANOMETER or by using REFERENCE INVASIVE
BLOOD PRESSURE MONITORING EQUIPMENT according to this part of ISO 81060 in each mode of operation.
EXAMPLE 1 Adult and neonatal modes.
EXAMPLE 2 Slow and fast CUFF deflation rate modes.
A CLINICAL INVESTIGATION shall be considered a TYPE TEST.
Consider compliance with the requirements of this subclause to exist when the criteria of the relevant
inspections and tests in this part of ISO 81060 are met.
4.2 Good clinical practice
All CLINICAL INVESTIGATIONS shall comply with the requirements of ISO 14155. 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.
The requirements of this International Standard, which are more specific than the corresponding requirements
of ISO 14155, shall prevail.
Check compliance by application of the requirements of ISO 14155.
2 © ISO 2013 – All rights reserved

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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER
5.1 Subject requirements
5.1.1 * Number
An auscultatory REFERENCE SPHYGMOMANOMETER CLINICAL INVESTIGATION shall consist of a minimum of 85
subjects. If not otherwise specified, at least three valid BLOOD PRESSURE DETERMINATIONS shall be taken for
each subject. There shall be a minimum of 255 valid paired BLOOD PRESSURE DETERMINATIONS.
Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
5.1.2 * Gender distribution
At least 30 % of the subjects shall be male and at least 30 % of the subjects shall be female.
Check compliance by inspection of the CLINICAL INVESTIGATION REPORT.
5.1.3 * Age distribution
For a SPHYGMOMANOMETER intended for use on adults and/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.
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.
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.
Children aged less than 3 years shall not be included in a CLINICAL INVESTIGATION utilizing auscultatory
DETERMINATIONS 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
For a SPHYGMOMANOMETER intended for use with a single CUFF size:
 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 at least 40 % shall have a limb circumference within the lower half;
and
 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 and at least 20 % shall have a limb circumference within the lower
quarter.
For a SPHYGMOMANOMETER intended for use with multiple CUFF sizes, each CUFF size shall be tested on at
1
least of the subjects, where n is the number of CUFF sizes.
2 n
Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT.
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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
5.1.5 * BLOOD PRESSURE distribution
At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≤ 100 mmHg
(13,33 kPa).
At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≥ 160 mmHg
(21,33 kPa).
At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE
≥ 140 mmHg (18,66 kPa).
At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≤ 60 mmHg
(8,0 kPa).
At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE
≥ 100 mmHg (13,33 kPa).
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 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.
If the SPHYGMOMANOMETER has undergone 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. If
the SPHYGMOMANOMETER has not previously 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.
The special PATIENT population shall be defined in clear terms and address the following attributes: gender
(see 5.1.2), age (see 5.1.3), limb size (see 5.1.4) and BLOOD PRESSURE (see 5.1.5). A summary of this
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
Unless otherwise indicated by the instructions for use of the SPHYGMOMANOMETER-UNDER-TEST, position the
subject such that the subject:
 is comfortable;
EXAMPLE Comfortably seated with legs uncrossed and feet flat on the floor.
 has the back, elbow and forearm supported;
 has the middle of the CUFF at the level of the right atrium of the heart.
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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
Recommend that the subject be as relaxed as possible and that the subject avoid talking during the entire
procedure. Before the first reading is taken, 5 min should elapse.
NOTE Additional details can be found in Reference [32].
5.2.2 * Observer preparation
Observers should be trained in using a proper methodology for performing a resting BLOOD PRESSURE
DETERMINATION by utilizing an accepted clinical protocol for BLOOD PRESSURE measurement.
References [8], [28], [29], [32] and [45] contain additional information. Observers should have sufficient
practice in performing BLOOD PRESSURE DETERMINATIONS.
Each observer's recording of observations of the REFERENCE SPHYGMOMANOMETER shall not be visible to the
other observer. The readings of the SPHYGMOMANOMETER-UNDER-TEST shall not be visible to either of these
observers.
EXAMPLE 1 Utilizing a third observer for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST.
EXAMPLE 2 Utilizing an electronic means for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST.
Instruct the observers to determine the DIASTOLIC BLOOD PRESSURE as the last audible Korotkoff sound (fifth
phase or K5), except when Korotkoff sounds are still audible with the CUFF deflated or in children between 3
years and 12 years of age, where the fourth phase (K4) is used. If K4 is not audible in a child, either K5 is
used or the subject is excluded.
NOTE Other than for children, K4 should be reserved for subjects in whom there is a large discrepancy between muffling
and disappearance (with the latter at times approaching zero mmHg).
Instruct the observers to record which Korotkoff sound has been used for the DETERMINATION of DIASTOLIC
BLOOD PRESSURE.
The Korotkoff sound used for DETERMINATION of DIASTOLIC BLOOD PRESSURE in the CLINICAL INVESTIGATION shall
be disclosed in the instructions for use of a SPHYGMOMANOMETER.
EXAMPLE 3 K5 was used on 65 subjects and K4 was used on 20 subjects.
5.2.3 * REFERENCE DETERMINATION
Two observers shall make simultaneous BLOOD PRESSURE DETERMINATIONS on each subject using a double
stethoscope.
Unless the SPHYGMOMANOMETER-UNDER-TEST is intended for use during significantly irregular heart rhythm and
if either observer detects significantly irregular heart rhythm, that DETERMINATION shall be excluded.
EXAMPLES 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.
Any pair of observers' DETERMINATIONS with a difference greater than 4 mmHg (0,53 kPa) shall be excluded.
The observers' individual values of each DETERMINATION shall be averaged according to Formula (1) to create
the REFERENCE BLOOD PRESSURE DETERMINATION.
pp
ref ref
ii,1 ,2
p  (1)
ref
i
2
where
th
p is the BLOOD PRESSURE determined by observer 1 for the i DETERMINATION;
ref
i ,1
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kSIST FprEN ISO 81060-2:2013
ISO 81060-2:2013(E)
th
p is the BLOOD PRESSURE determined by observer 2 for the i DETERMINATION;
ref
i,2
th
p is the REFERENCE BLOOD PRESSURE for the i DETERMINATION.
ref
i
The observer-to-observer differences shall be reviewed after completing a set of pairs of test-REFERENCE
DETERMINATIONS. If any DETERMINATIONS are excluded, additional pair(s) of DETERMINATIONS shall be taken to
ensure that the required number of valid test-REFERENCE pairs are available. A maximum of eight pairs of
DETERMINATIONS should be taken.
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). Reading of the values on the REFERENCE
SPHYGMOMANOMETER should be as accurate as possible. 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.
NOTE 3 For the purposes of this part of ISO 81060, the CUFF is considered part of the REFERENCE SPHYGMOMANOMETER.
A CUFF that does not comply with ISO 81060-1 cannot be used.
5.2.4 CLINICAL INVESTIGATION methods
5.2.4.1 Same arm simultaneous method
5.2.4.1.1 * Procedure
This method shall only be used with a SPHYGMOMANOMETER-UNDER-TEST:
 that has a CUFF compliant with ISO 81060-1;
 that is designed for use on the upper arm; and
 where
 the continuous linear deflation rate is between 2 mmHg/s (0,27 kPa/s) and 3 mmHg/s (0,40 kPa/s) or
 for a SPHYGMOMANOMETER-UNDER-TEST that controls the deflation as a function of the pulse rate, the
deflation rate is between 2 mmHg/pulse (0,27 kPa/pulse) and 3 mmHg/pulse (0,40 kPa/pulse).
Either arm may be utilized.
The SPHYGMOMANOMETER-UNDER-TEST shall not deflate prior to the detection of the REFERENCE DIASTOLIC
BLOOD PRESSURE. The SPHYGMOMANOMETER-UNDER-TEST may be modified to meet this criterion.
NOTE Valid same arm simultaneous DETERMINATIONS require the SPHYGMOMANOMETER-UNDER-TEST to inflate the CUFF
to at least 20 mmHg (2,67 kPa) higher than the actual SYSTOLIC BLOOD PRESSURE, as determined by the REFERENCE
SPHYGMOMANOMETER, and to at least 20 mmHg (2,67 kPa) below the actual DIASTOLIC BLOOD PRESSURE, as determined by
the REFERENCE SPHYGMOMANOMETER.
Perform the following:
a) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST
simultaneously determine the subject's BLOOD PRESSURE utilizing the same CUFF and inflation/deflation
cycle (see Figure 1). These data points are not used in the calculation of accuracy of the
SPH
...