EN 1060-1:1995+A2:2009

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.

General Information

• Status: Withdrawn
• Publication Date: 15-Dec-2009
• Withdrawal Date: 22-May-2012
• 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: 23-May-2012
• Completion Date: 23-May-2012
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 1060-1:2000+A2:2010 - Non-invasive sphygmomanometers - Part 1: General requirements

Relations

• Merged From: EN 1060-1:1995 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 19-Jan-2023
• Merged From: EN 1060-1:1995/FprA2 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 18-Jan-2023
• Merged From: EN 1060-1:1995/A1:2002 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 24-Oct-2009
• Replaced By: EN ISO 81060-1:2012 - Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
• Effective Date: 30-May-2012

Standards Content (Sample)

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
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
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

#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

and # $This European Standard 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 Directives, 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, 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.
...