SIST 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.
Thermometres médicaux - Partie 5: Performance des thermometres auriculaires (avec dispositif a maximum)
La présente partie de l'EN 12470 spécifie les exigences métrologiques et techniques des thermometres médicaux auriculaires avec dispositif a 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 12470-5:2003
01-september-2003
.OLQLþQLWHUPRPHWUL±GHO 'HORYDQMHLQIUDUGHþLKWHUPRPHWURY]DXãHVD V
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.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
2
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
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.
3
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
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
4
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
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 conditions and emissivity
3.10.2
calibration mode
mode in which an IR ear thermometer displays the temperature measured from a reference black body
3.10.3
estimated mode
mode in which an IR ear thermometer displays an estimated temperature for a body site other than the ear canal
3.11
probe
part of an IR ear thermometer that channels net infra-red radiation between the subject and the sensor
3.12
site offset
numerical value of the difference between a temperature reading in ear mode and in an estimated mode
4 Unit
o
The unit of temperature shall be the degree Celsius, symbol C.
5 Type of thermometers
IR ear thermometers determine body temperature of a subject via thermal radiation of the ear canal and/or
tympanic membrane.
5
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
6 Requirements
6.1 General
If the IR ear thermometer is designed for use with protective probe covers, the thermometer together with the probe
cover (complete thermometer) shall meet the requirements specified in this standard.
6.2 Range of displayed temperature
The IR ear thermometer shall cover in all modes the range of displayed temperature from 35,5 °C to 42,0 °C.
NOTE The range of displayed temperature can differ from the measuring range by an instrumental offset.
Testing shall be performed in accordance with 7.3.
6.3 Maximum permissible error
6.3.1 Maximum permissible error within ambient operating range
The maximum permissible error within ambient operating range as in 6.4.1 and the range of the displayed
temperature as in 6.2 shall be 0,2 °C.
Testing shall be performed in accordance with 7.4.
6.3.2 Maximum permissible error under extended operating conditions
If the IR ear thermometer gives a temperature reading outside the conditions in 6.2 and 6.4.1, the maximum
permissible error under those conditions shall be 0,3 °C.
Testing shall be performed in accordance with 7.5.
6.3.3 Maximum permissible error under changing environmental conditions
The maximum permissible error shall comply with 6.3.1 under changing ambient conditions. If the thermometer is
not capable of meeting the accuracy requirements, it shall not provide a temperature reading.
Testing shall be performed in accordance with 7.6.
6.3.4 Maximum permissible clinical repeatability
Clinical repeatability shall be determined separately for each device model, every patient age group (new-born,
children, and adults) for which the IR ear thermometer is intended to be used including febrile subjects.
Clinical repeatability shall not exceed 0,3 °C.
Testing shall be performed in accordance with 7.7.
6.4 Environmental requirements
6.4.1 Ambient operating conditions
The minimum ambient temperature operating range of the IR ear thermometer shall be from +16 °C to +35 °C and
the relative humidity range shall be up to at least 85 % (non-condensing).
Testing shall be performed in accordance with 7.4.
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
6.4.2 Effects of storage and long term stability
The IR ear thermometer shall meet the requirements specified in 6.3 after having been stored in an environment of
-25 °C to +55 °C and a relative humidity up to 85 % (non-condensing) for a period of 28 days.
Testing shall be performed in accordance with 7.8.
6.4.3 Electromagnetic compatibility
The IR ear thermometer shall comply with EN 60601-1-2.
6.4.4 Mechanical shock
IR ear thermometers with a housing of plastic or metal shall comply with 6.3 after testing according to 7.9.
If the IR ear thermometer does not meet the requirement after being subjected to mechanical shock, it shall not
provide a temperature reading.
6.5 Indicating unit
6.5.1 Digital increment
The digital increment of the indicating unit shall be 0,1 °C or smaller.
Testing shall be performed by visual inspection.
6.5.2 Display
Numerical values on the display shall be at least 4 mm high or optically magnified to appear that height.
Testing shall be performed by visual inspection.
6.5.3 Warning signals
The IR ear thermometer shall provide a visual warning or it shall not provide a temperature reading when one or
more of the following are outside the limits specified by the manufacturer:
a) power supply voltage;
b) measuring range;
c) ambient temperature operating range.
Testing shall be performed by visual inspection.
6.5.4 Variations of the voltage supply
For power supply by mains, the indicated temperature shall not show a change for variations from nominal values
of ± 10 % for voltage or ± 2 % for frequency.
For power supply by battery or an auxiliary power source, the IR ear thermometer shall provide a recognizable
indication or warning signal, or shall not display a temperature reading, when the voltage is outside the limits
specified by the manufacturer. If the supply voltage is within these specified limits, the thermometer shall meet the
requirements specified in 6.3.
Testing shall be performed in accordance with 7.10.
7
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
6.5.5 Modes
An IR ear thermometer shall have an ear mode.
For calibration purposes a calibration mode shall be accessible by either setting the instrument into that mode
directly or by a conversion technique from the ear mode.
NOTE 1 This can be identical to the ear mode.
If estimated modes are available, e.g. core, rectal, oral, the displayed values shall be clearly identified as estimates.
In addition, the manufacturer shall provide information on clinical accuracy and derivation of these estimates. The
information shall include site offsets, clinical bias and its standard deviation.
NOTE 2 See annex A for further information.
Testing shall be performed by visual inspection.
6.6 Construction
6.6.1 Material
All materials that can come in contact with the operator or subject shall be free from biological hazards.
NOTE See EN ISO 10993-1 as guidance for the selection of appropriate test methods.
6.6.2 General requirements for safety
The complete IR ear thermometer shall comply with EN 60601-1.
6.6.3 Mechanical
The temperature probe or probe tip, alone or in combination with probe covers, shall be smoothly rounded in order
to prevent tissue damage and injury to a subject of any age during use.
Testing shall be performed by visual and tactile inspection.
6.6.4 Cleaning, disinfection and/or sterilization
6.6.4.1 Thermometer
If the manufacturer indicates that the IR ear thermometer can be cleaned, disinfected and/or sterilized, instructions
for these processes shall be given.
After cleaning, disinfection and/or sterilization in accordance with the manufacturer’s specification, the IR ear
thermometer shall comply with the requirements specified in 6.3 and the marking of the housing shall not be
affected.
Testing shall be performed in accordance with 7.11.1.
6.6.4.2 Multiple use probe covers
When the manufacturer indicates that the probe cover is for multiple use, the complete IR ear thermometer shall
meet the requirements specified in 6.3 after it has been subjected to the cleaning, disinfection and/or sterilization
procedure as specified by the manufacturer.
Testing shall be performed in accordance with 7.11.2.
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
6.6.5 Probe covers
If a probe cover is required by the manufacturer, it shall maintain its physical integrity while being placed on the
probe or probe tip, and during temperature measurement to ensure a sanitary barrier between a subject and the
probe or probe tip.
If a probe cover is required by the manufacturer, the IR ear thermometer shall either not display a temperature
reading when it is used without a probe cover or shall contain appropriate information on the display that a new
probe cover shall be used prior to the next measurement.
The probe cover and the thermometer shall comply with the requirements specified in 6.3 when tested in
accordance with 7.4.
6.6.6 Functional safety test
The IR ear thermometer shall have an automatic self-test sequence. The correct operation shall be indicated by an
appropriate display.
The manufacturer shall provide information as to how the self-test sequence operates.
Testing shall be performed by visual inspection.
7 Test Methods
7.1 General
Laboratory accuracy of a particular type or model of an IR ear thermometer (with the specified probe covers if
applicable) shall be tested in ear mode or, if available, in calibration mode on samples selected in accordance with
7.2 to verify compliance with the requirements specified in 6.3.
7.2 Sampling
Each individual lot of IR ear thermometers and probe covers shall be subjected to testing, either individual or
statistical. For statistical testing the lot shall be homogenous and the mixing of the thermometers or probe covers
from various sources is not allowed.
The sampling plan shall correspond to ISO 2859-2:1985, level II with a limiting quality level LQ=5 %.
NOTE 1 Other sampling plans can be used if they are statistically equivalent.
NOTE 2 For suggested types of testing see annex B.
7.3 Testing for compliance of the range of displayed temperature
7.3.1 Apparatus
7.3.1.1 Black body radiator
Under laboratory conditions, the IR ear thermometer under test shall be tested against a black body radiator whose
radiance temperature is calibrated with an uncertainty not greater than 0,07 °C (coverage factor k=2). The
calibration shall be performed by either a national metrological institute or by a calibration laboratory competent for
radiation thermometric calibrations and shall be traceable to a national measurement standard.
The operating radiance temperature range of the black body radiator shall be sufficient to cover the full radiance
temperature range required for laboratory testing in accordance with this standard.
NOTE See annex C for information.
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
7.3.1.2 Climatic chamber
Climatic chamber, capable of producing the ranges of temperature and humidity given in 7.3, 7.4, 7.5, 7.6 and 7.8.
7.3.2 Reference laboratory conditions
The reference laboratory conditions shall be an ambient temperature of (23 ± 5) °C and a relative humidity of
(50 ± 20) %.
7.3.3 Procedure
Take a reading of the temperature of the black body with the IR ear thermometer under test in accordance with a
procedure recommended by the manufacturer for the particular IR ear thermometer under reference laboratory
conditions.
Repeat the tests at two black body temperatures, t set within ± 0,2 °C of the following temperatures:
BB
a) minimum displayed temperature minus offset as specified by the manufacturer +0,5 °C.
b) maximum displayed temperature minus offset as specified by the manufacturer –0,5 °C.
The temperature reading shall be displayed and the result recorded.
Report the temperature reading and assess the compliance with requirement 6.2.
7.4 Testing for compliance of the maximum permissible error within ambient operating range
7.4.1 Apparatus
The apparatus described in 7.3.1 shall be used.
7.4.2 Procedure
Take a reading of the temperature of the black body with the IR ear thermometer under test in accordance with the
procedure recommended by the manufacturer for the particular IR ear thermometer.
Repeat the tests for three black body temperatures approximately equally spaced throughout the range of
displayed temperature.
At each black body temperature, repeat the tests under the ambient conditions stated in Table 1.
Table 1 — Conditions of ambient temperature and humidity for testing an IR ear thermometer with a black
body for each of three black body settings
Operating Temperature Relative Humidity
(°C) (%)
16 to 18 less than 50
16 to 18 80 to 85
24 to 26 40 to 60
33 to 35 less than 25
33 to 35 80 to 85
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
Prior to the measurements, stabilize the IR ear thermometer at given conditions of ambient temperature and
humidity for a minimum of 30 min, or longer if so specified by the manufacturer.
At each combination of operating temperature and humidity in Table 1, take at least 3 readings for each black body
temperature, t . The number of readings shall be the same for all combinations. Use a new disposable probe
BB
cover (if applicable) for each test reading.
NOTE If measurements are performed without changing probe covers, the manufacturer should provide measurements on
the error of the thermometer and the probe covers separately that confirm that the error of the whole system including randomly
selected probe covers complies with 6.3. For information see annex D.
Carry out this procedure in the calibration mode or, if not available, in the ear mode.
If no calibration mode is available, use the correction method to derive unadjusted temperatures from readings in
ear mode in accordance with the manufacturer’s recommendation, which shall be available from the manufacturer
upon request.
The error in an individual reading is:
e = - (1)
t t
j BB
where
t is the individual reading of the IR ear thermometer when measuring the black body; and
j
t is the corresponding temperature of the black body.
BB
Assess the compliance of the obtained results for the measurement errors e with requirement 6.3.1.
7.5 Testing for compliance of maximum permissible error under extended operating conditions
7.5.1 Apparatus
The apparatus described in 7.3.1 shall be used.
7.5.2 Procedure
Take a reading of the temperature of the black body with the IR ear thermometer under test in accordance with a
procedure recommended by the manufacturer for the particular IR ear thermometer under reference conditions.
Repeat the tests at three black body temperatures, t set within ± 0,5 °C at three temperatures approximately
BB
equally spaced throughout the indicating range.
At each black body temperature, repeat the tests under the ambient conditions stated in Table 2.
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SIST EN 12470-5:2003
EN 12470-5:2003 (E)
Table 2 — Conditions of ambient temperature for testing an IR ear thermometer under extended operating
conditions
a
Relative humidity
Operating temperature
(°C) (%rh)
(t - 1) ± 1 Less than 30
max
(t + 1) ± 1
min Less than 50
(tmin + 1) ± 1 80 to 85
(t - 1) ± 1 80 to 85
max
a
t and t are the minimum and maximum ambient operating temperatures as specified by the manufacturer.
min max
Prior to the measurements, stabilize the IR ear thermometer at given conditions of ambient temperature and
humidity for a minimum of 30 min, or longer if so specified by the manufacturer.
At each combination of operating temperature and humidity in Table 2, take at least 3 measurements for each
black body temperature, t . The number of readings shall be the same for all combinations. Use a new disposable
BB
probe cover (if applicable) for e
...
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