EN 12470-3:2000+A1:2009

Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

This Part of EN 12470 specifies the performance requirements for compact clinical electrical thermometers with maximum device (non-predictive and predictive).
This European Standard applies to devices that, when taking temperatures, are powered by an internal power supply and that provide a digital indication of temperature.
This European Standard does not apply to clinical electrical thermometers for continuous measurement and thermometers intended to measure skin temperature.

Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung

Dieser Teil von EN 12470 legt die Leistungsanforderungen für medizinische elektrische (extrapolierende und
nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung fest.
Diese Europäische Norm gilt für Geräte, die während der Temperaturmessung durch eine interne Stromquelle
versorgt werden und eine digitale Temperaturanzeige liefern.
Diese Europäische Norm gilt nicht für elektrische medizinische Thermometer zur kontinuierlichen Messung
und für Thermometer zur Messung der Hauttemperatur.

Thermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif maximum

La présente partie de l'EN 12470 spécifie les exigences de performance relatives aux thermomètres médicaux
électriques compacts avec dispositif à maximum (à comparaison et à extrapolation).
La présente norme européenne s'applique aux dispositifs qui, lors du mesurage des températures, sont alimentés
par une source d'énergie interne, et qui donnent une indication numérique de la température.
La présente norme européenne ne s'applique pas aux thermomètres médicaux électriques de mesurage continu ni
aux thermomètres destinés à mesurer la température de la peau.

Klinični termometri - 3. del: Delovanje zaprtih trdnih električnih termometrov (brez umerjanja ali z njim)

General Information

• Status: Withdrawn
• Publication Date: 16-Jun-2009
• Withdrawal Date: 16-Oct-2012
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 12 - Clinical thermometers
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 17-Oct-2012
• Completion Date: 17-Oct-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 12470-3:2000+A1:2009 - Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device

Relations

• Merged From: EN 12470-3:2000 - Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
• Effective Date: 19-Jan-2023
• Merged From: EN 12470-3:2000/prA1 - Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
• Effective Date: 18-Jan-2023
• Replaced By: EN ISO 80601-2-56:2012 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
• Effective Date: 18-Jan-2012

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit MaximumvorrichtungThermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif maximumClinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12470-3:2000+A1:2009SIST EN 12470-3:2000+A1:2009en,fr,de01-oktober-2009SIST EN 12470-3:2000+A1:2009SLOVENSKI
STANDARD



SIST EN 12470-3:2000+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12470-3:2000+A1
June 2009 ICS 17.200.20 Supersedes EN 12470-3:2000English Version
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
Thermomètres médicaux - Partie 3: Performances des thermomètres électriques compacts (à comparaison et à extrapolation) avec dispositif à maximum
Medizinische Thermometer - Teil 3: Elektrische (extrapolierende und nicht extrapolierende) Kompaktthermometer mit Maximumvorrichtung This European Standard was approved by CEN on 13 May 1999 and includes Amendment 1 approved by CEN on 16 May 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 12470-3:2000+A1:2009: ESIST EN 12470-3:2000+A1:2009



EN 12470-3:2000+A1:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Unit .55Types of thermometers .56Performance requirements .57Test methods .88Information supplied by the manufacturer . 14Annex A (informative)
Suggested types of testing for the requirements of this standard . 16Annex B (informative)
Bibliography . 18Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 19 SIST EN 12470-3:2000+A1:2009



EN 12470-3:2000+A1:2009 (E) 3 Foreword This document (EN 12470-3:2000+A1:2009) has been prepared 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 ident
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