EN ISO 81060-2:2014

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.

General Information

• Status: Withdrawn
• Publication Date: 29-Apr-2014
• Withdrawal Date: 26-Nov-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 27-Nov-2019
• 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: SIST EN ISO 81060-2:2014 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)

Relations

• Replaces: EN 1060-4:2004 - Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
• Effective Date: 07-May-2014
• Replaced By: EN ISO 81060-2:2019 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
• Effective Date: 04-Dec-2019

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, C
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