EN 1060-4:2004

Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

This document describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure.

Nichtinvasive Blutdruckmessgeräte - Teil 4: Prüfverfahren zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven Blutdruckmessgeräten

Dieses Dokument beschreibt Prüfverfahren für Untersuchungen zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven Blutdruckmessgeräten, die für die indirekte Blutdruckmessung bestimmt sind.

Tensiomètres non invasifs - Partie 4 : Procédures pour déterminer la précision de l'ensemble du système des tensiomètres non invasifs automatiques

Le présent document décrit les procédures d'investigation visant à déterminer la précision de l'ensemble du système des tensiomètres non invasifs automatiques conçus pour le mesurage indirect de la pression artérielle.

Neinvazivni sfigmomanometri - 4. del: Preskusni postopki za ugotavljanje splošne točnosti sistema za avtomatizirane neinvazivne sfigmomanometre

General Information

• Status: Withdrawn
• Publication Date: 28-Sep-2004
• Withdrawal Date: 29-Apr-2014
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 10 - Non-invasive sphygmomanometers
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 30-Apr-2014
• Completion Date: 30-Apr-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 1060-4:2005 - Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

Relations

• Replaced By: EN ISO 81060-2:2014 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
• Effective Date: 07-May-2014

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtinvasive Blutdruckmessgeräte - Teil 4: Prüfverfahren zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven BlutdruckmessgerätenTensiometres non invasifs - Partie 4 : Procédures pour déterminer la précision de l'ensemble du systeme des tensiometres non invasifs automatiquesNon-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-4:2004SIST EN 1060-4:2005en01-marec-2005SIST EN 1060-4:2005SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1060-4September 2004ICS 11.040.55 English versionNon-invasive sphygmomanometers - Part 4: Test procedures todetermine the overall system accuracy of automated non-invasive sphygmomanometersTensiomètres non invasifs - Partie 4 : Procédures pourdéterminer la précision de l'ensemble du système destensiomètres non invasifs automatiquesNichtinvasive Blutdruckmessgeräte - Teil 4: Prüfverfahrenzur Bestimmung der Messgenauigkeit von automatischennichtinvasiven BlutdruckmessgerätenThis European Standard was approved by CEN on 9 July 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1060-4:2004: ESIST EN 1060-4:2005

Example of a record of a clinical investigation according to method N1 or N3.24 Annex C (informative)
Summary of the WHO recommendations for auscultatory blood pressure measurement.27 Annex D (informative)
Observer training and assessment etc.28 Annex E (informative)
A–deviations.30 Annex ZA (informative)
Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EC Medical Devices.31 Bibliography.32
This document includes a Bibliography. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. SIST EN 1060-4:2005

EN 1060-1:1995, Non-invasive sphygmomanometers – Part 1: General requirements. EN 1060-2, Non-invasive sphygmomanometers – Part 2: Supplementary requirements f
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