EN ISO 81060-2:2014
(Main)Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
ISO 81060-2:2013 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.
ISO 81060-2:2013 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.
ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use.
ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.
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-GERÄTE (MEDIZINISCHES ELEKTRISCHES GERÄT) fest, die zur nichtkontinuierlichen nichtinvasiven automatischen Schätzung des arteriellen BLUTDRUCKS unter Verwendung einer MANSCHETTE eingesetzt werden.
Dieser Teil der ISO 81060 gilt für 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 Langzeit-BLUTDRUCK-Überwachung, 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 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 gilt nicht für KLINISCHE PRÜFUNGEN NICHT-AUTOMATISIERTER NICHTINVASIVER BLUTDRUCKMESSGERÄTE beschrieben in ISO 81060-1 oder INVASIVER 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.
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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
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
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4
(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.
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
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
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
ISO 81060-2:2013(E) iv
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.
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 applic
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