Non-invasive sphygmomanometers - Part 1: General requirements

This Part of this European Standard specifies general requirements for non-invasive sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure.
It specifies performance, efficiency, mechanical and electrical safety requirements for these devices and gives test methods.
NOTE   This standard recommends that Luer lock connectors should not be used with these devices.

Nichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine Anforderungen

Diese Europäische Norm legt allgemeine Anforderungen für nichtinvasive Blutdruckmessgeräte und deren
Zubehör fest, die zur nichtinvasiven Messung des arteriellen Blutdrucks mit Hilfe einer aufblasbaren
Manschette dienen.
Sie legt Anforderungen hinsichtlich der Gebrauchstauglichkeit, Messsicherheit, mechanischen und
elektrischen Sicherheit dieser Geräte fest sowie deren Prüfverfahren.
ANMERKUNG Diese Norm empfiehlt, verriegelbare Luer-Anschlussstücke bei diesen Geräten nicht zu verwenden.

Tensiomètres non invasifs - Partie 1: Exigences générales

Cette partie de la norme européenne prescrit les exigences générales des tensiomètres non invasifs et de leurs
accessoires qui, à l'aide d'un brassard gonflable, sont utilisés pour la mesure non invasive de la pression artérielle.
Elle prescrit les exigences de performance, d'efficacité et de sécurité mécanique et électrique de ces dispositifs,
et décrit les méthodes d'essai.
NOTE Cette norme européenne recommande de ne pas utiliser les raccords Luer avec ces dispositifs.

Neinvazivni sfigmomanometri - 1. del: Splošne zahteve

Ta del tega evropskega standarda določa splošne zahteve za neinvazivne sfigmomanometre in njihove dodatke, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje arterijskega krvnega tlaka. Določa zahteve za zmogljivost, učinkovitost, mehansko in električno varnost za te pripomočke in podaja preskusne metode.

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 1. del: Splošne zahteveNichtinvasive Blutdruckmeßgeräte - Teil 1: Allgemeine AnforderungenTensiomètres non invasifs - Partie 1: Exigences généralesNon-invasive sphygmomanometers - Part 1: General requirements11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-1:1995+A2:2009SIST EN 1060-1:2000+A2:2010en,fr,de01-marec-2010SIST EN 1060-1:2000+A2:2010SLOVENSKI

SIST EN 1060-1:2000+A2:2010

EN 1060-1:1995+A2
December 2009 ICS 11.040.55 Supersedes EN 1060-1:1995English Version
Non-invasive sphygmomanometers - Part 1: General requirements
Tensiomètres non invasifs - Partie 1: Exigences générales Nichtinvasive Blutdruckmessgeräte - Teil 1: Allgemeine Anforderungen This European Standard was approved by CEN on 14 April 1995 and includes Amendment 1 approved by CEN on 6 April 2002 and Amendment 2 approved by CEN on 15 November 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-1:1995+A2:2009: ESIST EN 1060-1:2000+A2:2010

EN 1060-1:1995+A2:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Cuff .55Display .56Units .57Requirements .68Test methods .69Information supplied by the manufacturer .9Annex ZA (informative)
#Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$ . 11 SIST EN 1060-1:2000+A2:2010

EN 1060-1:1995+A2:2009 (E) 3 Foreword This document has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. The European Standard "non-invasive sphygmomanometers" consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems #deleted text$ #Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers$ 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 June 2010, and conflicting national standards shall be withdrawn at

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