EN 12470-5:2003

Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

This Part of EN 12470 specifies the metrological and technical requirements for clinical infra-red (IR) ear thermometers with maximum device for intermittent determination of human body temperature.
This European Standard applies to devices that when taking temperatures are powered by a power supply either internal or by mains and that provide an indication of the subject's body temperature through measurement of thermal radiation from all or part of the ear canal.
NOTE:   Devices designed to measure tympanic membrane temperature only are also covered by this standard.

Medizinische Thermometer - Teil 5: Anforderungen an Infrarot- Ohrthermometer (mit Maximumvorrichtung)

Dieser Teil der EN 12470 legt die messtechnischen und sonstigen technischen Anforderungen an medizinische Infrarot (IR)-Ohrthermometer mit Maximumvorrichtung zur kurzfristigen Messung der mensch-lichen Körpertemperatur fest.
Diese Europäische Norm gilt für Geräte, die während der Temperaturmessung durch eine interne Stromquelle oder das Netz versorgt werden und die menschliche Körpertemperatur durch Messung der Wärmestrahlung im gesamten oder in einem Teil des Gehörganges anzeigen.
ANMERKUNG   Diese Norm gilt auch für Geräte zur ausschließlichen Bestimmung der Trommelfelltemperatur.

Thermomètres médicaux - Partie 5: Performance des thermomètres auriculaires (avec dispositif à maximum)

La présente partie de l'EN 12470 spécifie les exigences métrologiques et techniques des thermomètres médicaux auriculaires avec dispositif à maximum pour une détermination intermittente de la température du corps humain.
La présente Norme européenne s'applique aux dispositifs qui, lors du mesurage des températures, sont alimentés par une source d'énergie soit interne soit sur secteur, et qui fournissent une indication de la température du corps humain en mesurant le rayonnement thermique de tout ou partie du conduit auditif.
NOTE   Les dispositifs conçus pour mesurer exclusivement la température de la membrane tympanique sont également couverts par la présente norme.

Klinični termometri – 5. del: Delovanje infrardečih termometrov za ušesa (s popolno opremo)

General Information

• Status: Withdrawn
• Publication Date: 15-Apr-2003
• 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: 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 12470-5:2003 - Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)

Relations

• 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
• Parent: EN 12470-1:2000 - Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12470-5:2003
01-september-2003
.OLQLþQLWHUPRPHWUL±GHO'HORYDQMHLQIUDUGHþLKWHUPRPHWURY]DXãHVDV
SRSROQRRSUHPR
Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with
maximum device)
Medizinische Thermometer - Teil 5: Anforderungen an Infrarot- Ohrthermometer (mit
Maximumvorrichtung)
Thermometres médicaux - Partie 5: Performance des thermometres auriculaires (avec
dispositif a maximum)
Ta slovenski standard je istoveten z: EN 12470-5:2003
ICS:
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
SIST EN 12470-5:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 12470-5:2003

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SIST EN 12470-5:2003
EUROPEAN STANDARD
EN 12470-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2003
ICS 17.200.20
English version
Clinical thermometers - Part 5: Performance of infra-red ear
thermometers (with maximum device)
Thermomètres médicaux - Partie 5: Performance des Medizinische Thermometer - Teil 5: Anforderungen an
thermomètres tympaniques à infrarouges (avec dispositif à Infrarot- Ohrthermometer (mit Maximumvorrichtung)
maximum)
This European Standard was approved by CEN on 27 December 2002.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12470-5:2003 E
worldwide for CEN national Members.

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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
Contents
page
Foreword.3
1 Scope .4
2 Normative References .4
3 Terms and definitions.4
4 Unit .5
5 Type of thermometers .5
6 Requirements .6
6.1 General.6
6.2 Range of displayed temperature .6
6.3 Maximum permissible error.6
6.4 Environmental requirements .6
6.5 Indicating unit.7
6.6 Construction.8
7 Test Methods.9
7.1 General.
...