EN 12470-5:2003
(Main)Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2003
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.9
7.2 Sampling .9
7.3 Testing for compliance of the range of displayed temperature.9
7.4 Testing for compliance of the maximum permissible error within ambient operating range .10
7.5 Testing for compliance of maximum permissible error under extended operating conditions.11
7.6 Testing for compliance of maximum permissible error under changing environmental
conditions.12
7.7 Testing for compliance with maximum permissible clinical repeatability - Procedure.13
7.8 Testing for compliance with the effect of storage and long term stability .14
7.9 Method of test for mechanical shock .14
7.10 Testing for compliance with the variation of the supply voltage.14
7.11 Testing for compliance with cleaning and disinfection.15
8 Information supplied by the manufacturer.16
8.1 General.16
8.2 Marking .16
8.3 Instructions for use .16
Annex A (informative) Clinical trial to determine clinical accuracy .18
A.1 Introduction .18
A.2 Clinical accuracy.18
A.3 Clinical trial procedure .18
A.4 Clinical bias and its standard deviation .19
A.5 Clinical repeatability .19
Annex B (informative) Suggested types of testing for the requirements of this standard.21
Annex C (informative) Example for a suitable design of a black body radiator .23
Annex D (informative) Alternative approaches to prove compliance with 6.3.26
D.1 General.26
D.2 Separation of the maximum permissible error for the instrument and for the probe covers.26
D.3 Calculation of the error using error propagation analysis .26
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives .27
Bibliography .28
Foreword
This document (EN 12470-5:2003) has been prepared by Technical Committee CEN/TC 205 "Non-active medical
devices", the secretariat of which is held by BSI.
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 October 2003, and conflicting national standards shall be withdrawn at the latest
by October 2003.
This document 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 Directive(s), see informative annex ZA, which is an integral part of this document.
This European Standard applies to clinical thermometers which are used for measuring the body temperature of
humans.
EN 12470 consists of the following Parts under the general title “Clinical thermometers”:
Part 1: Metallic liquid-in-glass thermometers with maximum device
Part 2: Phase change-type (dot matrix) thermometers
Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
Part 4: Performance of electrical thermometers for continuous measurement
Part 5: Performance of infra-red ear thermometers (with maximum device)
Annexes A, B, C, and D are informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
1 Scope
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.
2 Normative References
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 980, Graphical symbols for use in the labeling of medical devices.
EN 1041, Information supplied by the manufacturer with medical devices.
EN 60601-1, Medical electrical equipment - Part 1: General requirements for safety (IEC: 60601-1:1988).
EN 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard -
Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001).
ISO 2859-2:1985, Sampling procedures for inspection by attributes - Part 2: Sampling plans indexed by limiting
quality (LQ) for isolated lot inspection.
3 Terms and definitions
For the purposes of this European Standard the following terms and definitions apply.
3.1
ambient operating range
ambient temperature and humidity which allows correct operation of an IR ear thermometer
3.2
black body
reference source of infra-red radiation made in the shape of a cavity and characterized by precisely known
temperature of the cavity walls and having effective emissivity at the cavity opening sufficiently near to one
3.3
body temperature
temperature measured at a human body site, e.g. pulmonary artery, distal œsophagus, urinary bladder, ear canal,
oral, rectal or axillary
3.4
clinical accuracy
ability of an IR ear thermometer to give a reading close to the temperature of the site that it purports to represent as
measured by the reference thermometer
3.5
clinical bias
clinical bias and its standard deviation specifies an average difference between temperatures estimated by the
device under test and temperatures of subjects as measured by the reference thermometer
3.6
clinical repeatability
experimental standard deviation of changes in multiple ear canal temperature readings as taken from the same
subject from the same ear with the same IR ear thermometer by the same operator
3.7
contact thermometer
instrument which is adapted for measuring temperature by means of thermal contact when negligible thermal
energy flows between the thermometer and the object of measurement
3.8
infra-red ear thermometer (IR ear thermometer)
opto-electronic instrument that is capable of non-contact infra-red temperature measurement when applied to the
ear canal of a subject
3.9
maximum device
part or function of the thermometer which stores and indicates the numerical value of the maximum temperature
measured
3.10
modes
3.10.1
ear mode
mode in which the IR ear thermometer displays the temperature measured from a subject’s ear canal. This mode
allows for corrections to compensate for variations such as ambient con
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