Czech Metrology Institute  
Okružní 31,  638 00 
Brno 
1. ------IND- 2010 0143 CZ- EN- ------ 20100319 --- --- PROJET 
 The Czech Metrology Institute (CMI), as the comp etent local body for stipulating metrological and 
technical requirements for a specified measuring devi ce and for the stipulation of test methods for type 
approval and for verification of a specified measur ing device pursuant to Section 14(1) of Act No. 
505/1990 Coll., on Metrology, as amended, and pursua nt to provisions of Section 172 et seq. of Act 
No. 500/2004 Coll., the Administrative Code, as ame nded (hereinafter the "AC"), has on 21 December 
2009 commenced ex officio proceed ings pursuant to Section 46 of the AC, and based on supporting 
documents issues this: 
 
 
I. 
M E A S U R E  O F  A  G E N E R A L  N A T U R E 
number: 0111-OOP-C006-09 
reference no. 0313/006/09/Pos., 
publication date: 21 December 2009 
 
stipulating metrological and technical requirements for specified measuring devices, including 
test methods for verifying specified measuring devices: 
"electronic medical and veterinary thermometers" 
 
1   Basic definitions 
For the purposes of this measure of a general natu re, terminology and defini tions contained in the 
VIM1) and the following apply: 
1.1    Compact electronic thermometers 
1.1.1    compact electronic thermometer: a dermal thermometer composed of a temperature probe 
and a display unit that are permanently joined 
1.1.2    electronic medical thermometer: a thermometer used to measure body temperature in human 
medicine 
1.1.3   electronic veterinary thermometer: a thermometer used to measure body temperature in vet-
erinary medicine 
1.1.4    thermometer with extrapolation: a device that calculates, without waiting for temperature 
equilibrium to be achieved, using temperature da ta transmission and a mathematical algorithm, the 
maximum temperature of a probe in contact with a body cavity, and preserves the calculated maxi-mum temperature value, either for a speci fied time, or until cancelled by the user 
                                                     
 
1)   International Vocabulary of Metrology - Basi c and General Concepts and Associated Terms (VIM) Measure of a General Nature No. 0111-OOP-C006-09 
2 1.1.5   thermometer without extrapolation: a device with a part or function that indicates a tempera-
ture for a required amount of time, measured by a temperature probe in contact with a body cavity, 
which it then displays and maintains at the maximum temperature value, either for a specified time, or 
until cancelled by the user 
1.1.6   electronic thermometer for continuous measurement: a device composed of a display unit 
and connected temperature probe that continuo usly measures and displays body temperature 
1.1.7   display unit: the part of an electronic thermometer that processes the signal output by the tem-
perature probe and displays the temperature value 
1.1.8    maximum device (of a thermometer): a part of function of an electronic thermometer that 
stores and displays the maximum temperature as a numerical value 
1.1.9   temperature probe: the part of a thermometer used to determine body temperature and that 
contains a temperature sensor and other parts, incl uding a cover, seals, internal conductors and if nec-
essary, connectors 
1.2    Electronic infrared non-contact thermometers 
1.2.1   electronic infrared non-contact thermometer: an optoelectronic device capable of perform-
ing non-contact temperature measurement using heat radiated by the given location 
1.2.2    electronic infrared non-contact ear thermometer: a thermometer used to ascertain the inter-
nal temperature of the human body by measuring inside the ear canal 
1.2.3   electronic infrared non-contact dermal thermometer: a thermometer used to ascertain the 
surface temperature of the human body, most often measured on the surface of the forehead (forehead 
thermometer, temporal scanning thermometer, etc.) 
1.2.4   ear or dermal mode: a mode in which an electronic infrared thermometer displays the tem-
perature measured in the ear canal or on the skin of  the subject; this mode allows for corrections to 
compensate for discrepancies, e.g. environmental conditions or emission capabilities 
1.2.5   calibration mode: a mode in which an electronic infrared medical thermometer displays the 
measured temperature of a reference radiation source 
1.2.6   estimation mode: a mode in which an electronic infrared ear thermometer displays an esti-
mated temperature of a certain body part other than the ear canal 
2   Metrological requirements 
Metrological requirements are founded on requirement s of Government Order No. 336/2004 Coll., 
laying down requirements for medical devices2), and also incorporate requirements of harmonized 
standards. During verification of measuring device m odels approved by the Metrology Act, metrologi-
cal requirements extant during their introduction apply. 
2.1    Compact electronic thermometers 
2.1.1   Service conditions 
The minimum ambient temperature range is from +10 °C to +35 °C. 
                                                      
2)  This government order implements Council Directive 93/42/EEC of 14 June 1993 concerning medical de-
vices, as amended. Measure of a General Nature No. 0111-OOP-C006-09 
3 2.1.2   Measurement range 
The measurement range must be at least from 35.5 °C to 42.0 °C. If the measured temperature value is 
outside this minimum measurement rage, the thermometer must provide a visual or audio warning. 
Digital increments of the displayed unit must be at most 0.1 °C. 
2.1.3   Maximum allowed error 
The maximum allowed error of medical thermometers  in the measurement range from 35.5 °C to 42.0 
°C is ± 0.1 °C in an ambient temperature range of 18 °C to 28 °C. 
The maximum allowed error of veterinary thermo meters under the same conditions is ± 0.2 °C. 
Outside the measurement range or outside the ambi ent temperature range, the maximum allowed error 
must not be greater than double this specified value. 
2.2    Electronic thermometers for continuous measurement 
2.2.1   Service conditions 
The minimum ambient temperature range must be  from +10 °C to +40 °C, the minimum humidity 
range from 30% to 75% relative humidity. 
2.2.2   Measurement range 
The continuous measurement range must be at least  from 25.0 °C to 45 °C. If the measured tempera-
ture value is outside the thermometer’s minimum me asurement rage, it must provide a visual or audio 
warning. 
Digital increments of the displayed unit must be at most 0.1 °C. 
2.2.3   Maximum allowed error 
The maximum allowed error of the complete ther mometer in the measurement range from 25.0°C to 
45.0 °C is ± 0.2 °C. The maximum allowed error of the display unit or temperature probe must not be 
greater than ± 0.1 °C. 
For thermometers whose measuring range is great er than 25.0 °C to 45 °C, the maximum allowed 
error for temperatures below 25.0 °C and above 45 °C must not be greater than double the specified values. 
2.3    Electronic infrared thermometers 
2.3.1   Service conditions 
The minimum ambient temperature range must be  from +16 °C to +35 °C, the minimum humidity 
range up to 85% relative humidity without condensation.  
2.3.2   Measurement range 
2.3.2.1   An electronic infrared ear thermometer must have a temperature measuring range in all 
modes from at least 35.5 °C to 42.0 °C. 
2.3.2.2    An electronic infrared dermal thermometer must have a temperature measuring range in all 
modes from at least 22.0 °C to 40.0 °C. 
2.3.2.3   Digital increments of the displayed unit must be at most 0.1 °C. Measure of a General Nature No. 0111-OOP-C006-09 
4 2.3.3   Maximum allowed error 
2.3.3.1    The maximum allowed error of ear thermomete rs within the extent of service conditions 
specified by Article 2.3.1 and in the section of th e measurement range from 36.0 °C to 39.0 °C is 
± 0.2 °C.  
Outside the above section of the measurement range or outside the extent of service conditions, the 
maximum allowed error is ± 0.3 °C. 
2.3.3.2   The maximum allowed error of dermal thermo meters over the entire range of service condi-
tions and over the entire measurement range is ± 0.3 °C. 
3   Technical requirements 
Technical requirements are founded on requirement s of Government Order No. 336/2004 Coll., laying 
down requirements for medical devices2) and also incorporate requirements of harmonized standards. 
During verification of measuring device models ap proved by the Metrology Act, metrological re-
quirements applicable during their introduction apply. 
3.1    Compact electronic thermometers 3.1.1   Display unit 
The numerals on the display must be at least four millimetres high or optically magnified to appear 
this high. After power is switched on, all segments and symbols on the display unit must be activated for at least one second. 
The display unit must include a means of automatic ch ecking whose accuracy is equal to or better than 
the display unit’s maximum allowed error. 
3.1.2   Power source 
Compact electronic thermometers must automatically provide a visual or audio warning that the volt-
age of the power source is outside the limits stipulated by the manufacturer. 
3.2   Electronic thermometers for continuous measurement 
3.2.1   Display unit 
The numerals on the display must be at least four millimetres high or optically magnified to appear 
this high. The numerical values on the display unit must refresh at least every 10 seconds. After power 
is switched on, all segments and symbols on the display unit must be activated for at least two sec-onds. 
The display unit must include a means of automatic checking with an accuracy equal to or better than 
the display unit’s maximum allowed error stipulated by the manufacturer. 
3.2.2   Temperature probe 
If the temperature probe, sans cover, is immersed in to an electrically conductive liquid, its insulation 
must be such that the change in displayed temperature is at most ± 0.02 °C. 
The temperature probe must meet the requirements stipulated in article 2.2.3 even after cleaning, dis-
infection or sterilisation in accordance with the manufacturer’s specifications. 
3.2.3   Power source 
When powered from the mains power supply, the temp erature displayed by the thermometer must not 
change when the power supply voltage fluctuates by  ± 10 % and the frequency by ± 2 % compared to 
nominal values. Measure of a General Nature No. 0111-OOP-C006-09 
5 When being powered by a battery or auxiliary power source, the thermometer must provide a visual or 
audio warning that the power supply voltage is equal to or less than the value stipulated by the manu-
facturer. 
3.3   Electronic infrared thermometers 
3.3.1    Infrared thermometer types 
An electronic infrared ear or dermal thermometer must function in ear or dermal mode whose meas-
urement conditions must be stipulated by the manufacturer. 
A calibration mode must be available either by sw itching the measuring device directly into this mode, 
or by switching from ear or dermal mode, or it can be identical to them. If estimation modes are avail-able (e.g. marrow, rectal, oral), the values displaye d on the display unit must be labelled in an unmis-
takeable way as estimated values. 
3.3.2   Display unit 
The numerals on the display must be at least four millimetres high or optically magnified to appear 
this high. After power is switched on, all segments and symbols on the display unit must be activated for at least two seconds. 
An electronic infrared thermometer must have au tomatic monitoring of self-checking functions and 
proper operation must be indicated by a suitable di splay on the display unit. The thermometer must 
display its current mode. 
An electronic infrared thermometer must provide a vi sual warning or not display temperature data if 
the measured temperature, ambient temperature or power supply voltage are outside the range stipu-
lated by the manufacturer. 
3.3.3   Temperature probe 
The temperature probe must meet the requirements sti pulated in Article 2.3.3.1 or 2.3.3.2 even after 
cleaning, disinfection and sterilisation according to the manufacturer's specifications. 
If the manufacturer requires that a temperature probe cover be in place while using the electronic in-
frared thermometer, it must not display a temperat ure indication without the cover in place, or the 
display unit must show information that the prob e cover must be replaced prior to measuring body 
temperature. When placing the cover on the temperature probe, its physical integrity must be pre-
served. 
If the thermometer is designed for use with protective temperature probe covers, the thermometer 
along with the probe cover must meet the requirements stipulated by this measure. 
3.3.4   Power supply 
When powered from the mains power supply, the te mperature displayed must not change when the 
power supply voltage fluctuates by ± 10 % and the frequency by ± 2 % compared to nominal values. 
When being powered by a battery or auxiliary power source, the thermometer must provide a visual or 
audio warning, or it must not display temperature, if  the voltage falls outside the range stipulated by 
the manufacturer. 
 
4   Measuring device labelling 
4.1   In general 
The thermometer must have information provided by the manufacturer and graphical markings for 
designation of medical aids. The thermometer must al so be labelled with the CE mark and the number Measure of a General Nature No. 0111-OOP-C006-09 
6 of the notified subject that assessed its conformanc e. In the case of thermo meters introduced in accor-
dance with the Metrology Act, the thermometer must be labelled with a type approval mark. 
All labels and markings must be easily visible and readable under normal working conditions, perma-
nent, and must not hinder the reading of the measuring device's data. 
4.2    Labels and markings on compact electronic thermometers 
Aside from labelling required according to Article 4.1,  the measuring device must be labelled with at 
least the following information: 
a) the manufacturer’s name, 
b) model or type name, 
c) serial number, 
d) measuring range and a "°C" measuring unit mark ing associated with the numerical value (if 
not indicated on the display), 
e) orientation or position during use, if this affects the measurement result, 
f) information that the temperature value di splayed is the result of a calculation, 
g) information on the specific temperature measurement range, if the overall measurement range 
is greater, 
h) body location (e.g. mouth or anus), if there is any limitation, e.g. for thermometers with ex-
trapolation, 
i) the warning "Not water-resistant " or equivalent declaration if the thermometer does not meet 
requirements for contact with water. 
4.3    Labels and markings on electroni c thermometers for continuous measurement 
Aside from labelling required according to Article 4.1,  the measuring device must be labelled with at 
least the following information: 
a) the manufacturer’s name, 
b) model or type name, 
c) serial number, 
d) measuring range and a "°C" measuring unit mark ing associated with the numerical value (if 
not indicated on the display), 
e) orientation or position during use, if this affects the measurement result, 
f) for the temperature probe, the location on the body where temperature should be measured, if 
there is a restriction (for example the mouth or anus), 
g) indication of the specific measurement range, if it is greater than the minimum measurement 
range (see Article 2.2.3). 
4.4    Labels and markings on electronic infrared thermometers 
Aside from labelling required according to Article 4.1,  the measuring device must be labelled with at 
least the following information: 
a) the manufacturer’s name, 
b) model or type name, 
c) serial number, 
d) year and month of manufacture and initial calibration, if different Measure of a General Nature No. 0111-OOP-C006-09 
7 e) measuring range and a "°C" measuring unit mark ing associated with the numerical value (if 
not indicated on the display), 
f) measurement location on the body, 
g) estimation modes, if not indicated on the display, 
h) whether protective probe covers are required. 
4.5   Special information provided by the manufacturer 
For electronic infrared thermometers, the manufacturer must provide information on clinical accuracy, 
especially information on temperature deviation of the body temperature measurement location, clini-
cal systematic error, its standard deviation and the derivation of these estimates. 
He must also provide information on the sequence an d effect of the thermometer’s self-checking func-
tions. 
5    Measuring device type approval 
These measuring devices are not subject to type ap proval in accordance with Act No. 505/1990 Coll., 
on metrology, as amended. 
6   Initial verification 
The initial verification procedure3) is identical to the subsequent verification procedure in accordance 
with Chapter 7. 
7   Subsequent verification 
The following tests are performed during subse quent verification of electronic thermometers: 
a) a visual inspection, 
b) an accuracy test. 
7.1   Visual inspection  
The following is checked dur ing a visual inspection: 
– whether the thermometer submitted for verificati on conforms to the approved type or with a 
design for which conformance was declared during market introduction, 
– whether it is not physically damaged or does not exhibit defects visible to the naked eye, 
– whether the lens of an infrared thermometer’s outer optical assembly does not exhibit defects, 
– whether it is properly labelled. 
If the thermometer does not pass external inspection, it is not tested further. 
7.2    Compact electronic thermometer accuracy test 
7.2.1   Test equipment 
The following test equipment is used: 
                                                      
3) Initial verification applies only to measuring devices that at that time have a valid type approval certificate, and 
to measuring devices following repair. Measure of a General Nature No. 0111-OOP-C006-09 
8 – a reference thermometer with a display device resolution of 0.01 °C and an extended meas-
urement uncertainty less than or equa l to ± 0.02 °C (extension coefficient k = 2) to determine 
the temperature of the liquid bath, 
– a liquid bath with a volume of at least 5 l fo r a minimum liquid temperature of +30 °C to 
+45 °C, with temperature regulation and a mixing device, that ensure temperature stability of 
less than or equal to ± 0.02 °C and a temperature field homogeneity less than or equal to 
± 0.01 °C at an arbitrary temperature. 
7.2.2   Test method 
The accuracy test involves comparing values measure d by the thermometer with temperature values 
on the reference thermometer in a liquid bath at an ambient reference temperature of (23 ± 5) °C and 
relative humidity of (50 ± 20) % with the device ope rating within the specified power supply voltage 
range. 
Thermometers having a measurement interval range of ≤ 10 °C are tested at minimally two points, and 
those with a measurement range of > 10 °C at mini mally three points that include 37 °C and 41 °C for 
medical thermometers and 38 °C and 42  °C for veterinary thermometers. 
The difference between the measured temperature value and the reference temperature value must 
meet requirements specified in Article 2.1.3 at every measurement point. 
7.3    Continuous-measurement el ectronic thermometer accuracy test 
7.3.1   Test equipment 
The following test equipment is used: 
a) a reference thermometer with a display device resolution of 0.01 °C and an extended meas-
urement uncertainty less than or equal to ± 0.02 °C (extension coefficient k = 2) to determine 
the temperature of the liquid bath, 
b) a liquid bath with a volume of at least 5 l fo r a minimum liquid temperature of +30 °C to 
+45 °C, with temperature regulation and a mixing device that ensure temperature stability of less than or equal to ± 0.02 °C and a temper ature field homogeneity less than or equal to 
± 0.01 °C at an arbitrary temperature, 
c) a temperature probe simulator with extended measu rement uncertainty no greater than 0.01 °C 
(calculated for an extension coefficient of k = 2) according to information from the manufac-
turer, 
d) a temperature probe tester to transform the measured physical characteristics of the probe to 
temperature values by measuring changes in thes e characteristics related to temperature with 
an extended measurement uncertainty of this ph ysical characteristic that in the measurement 
range is no greater than 0.01 °C (calcu lated for an extension coefficient of k = 2) according to 
information from the manufacturer. 
7.3.2   Test method 
An accuracy test for continuous-measurement electr onic thermometers may be performed either as a 
test of the complete thermometer, or as independent tests of the display unit and the temperature 
probe. 
7.3.2.1    Test of the complete thermometer 
The accuracy test involves comparing values measure d by the thermometer with temperature values 
on the reference thermometer in a liquid bath at an ambient reference temperature of (23 ± 5) °C and 
relative humidity of (50 ± 20) % with the device ope rating within the specified power supply voltage 
range. Measure of a General Nature No. 0111-OOP-C006-09 
9 Thermometers having a measurement interval range of ≤ 10 °C are tested at minimally three points, 
and those with a measurement range of > 10 °C at minimally five points that include 36 °C, 37 °C and 
41 °C for medical thermometers. 
The difference between the measured temperature value and the reference temperature value must 
meet requirements specified in Article 2.2.3 at every measurement point. 
7.3.2.2   Test of part of the thermometer 
Display unit characteristics are tested using a temperature probe simulator according to 7.3.1 c). The difference between the temperature displayed on  the display unit and the corresponding simulated 
temperature values must meet display unit requirements according to Article 2.2.3. 
When testing only the probe, it is immersed in a calibration temperatur e bath like for the test of the 
complete thermometer. The temperature probe is connected to a tester according to 7.3.1 d). Each temperature probe value obtained in this manner is co mpared with the value displayed by the reference 
thermometer in the bath. 
The difference between the measured temperature value and the reference temperature value must 
meet requirements specified in Article 2.2.3 at every measurement point. 
7.4    Electronic infrared thermometer accuracy test 
7.4.1   Test equipment 
The following test equipment is  used for the accuracy test: 
a) a reference thermometer with a display device resolution of 0.01 °C and an extended meas-
urement uncertainty less than or equal to ± 0.03 °C (extension coefficient k = 2) to determine 
the temperature of a black body, 
b) a liquid bath with a volume of at least 3 l fo r a minimum liquid temperature of +30 °C to 
+45 °C, with temperature regulation and a mixing device that ensure temperature stability of 
less than or equal to ± 0.02 °C and a temper ature field homogeneity less than or equal to 
± 0.01 °C at an arbitrary temperature, 
c) a black body in the shape of a cavity, modified for use in a liquid bath, with the ability to set 
black body temperature using a reference thermometer with an evaluation device; the tempera-ture of the black body must be specified with  an extended measurement uncertainty not ex-
ceeding ± 0.07 °C (extension coefficient k = 2), 
d) an aperture to decrease the size of the opening into the cavity of the black body that permits 
proper positioning of the tested thermometer in the black body. 
7.4.2   Test method 
The accuracy test of the thermometer, either alone  or with a specified temperature probe cover (if 
called for by the manufacturer) must be performed in calibration mode; if this mode is not available, 
then in ear or dermal mode. 
Thermometers are tested at a reference temperature of (23 ± 5) °C and relative humidity of (50 ± 20)% 
by measuring the radiation of a black body w ith an aperture immersed in a liquid bath. 
Thermometer accuracy is determined by comparing the values measured by the thermometer with the 
reference temperature value of the black body in the liquid bath. The black body temperature is meas-
ured by the thermometer being tested according to the procedure recommended by the manufacturer. 
The accuracy of ear thermometers is usually tested at three points at temperatures of 36 °C, 37 °C 
and 41 °C set with an accuracy of ± 0.5 °C.  
The accuracy of dermal thermometers is usually tested at three points at temperatures of 23 °C, 30 °C 
and 38 °C set with an accuracy of ± 1.0 °C. Measure of a General Nature No. 0111-OOP-C006-09 
10 The difference between the measured temperature value and the reference temperature value must 
meet requirements specified in Article 2.3.3 at every measurement point. 
8   Notified standards 
To specify metrological and technical requirements for measuring devices and to specify verification 
test methods stemming from this measure of a gene ral nature, the CMI notifies Czech technical stan-
dards, other technical standards or technical documen ts of international or foreign organizations or 
other technical documents containing detailed tec hnical requirements (hereinafter "notified stan-
dards"). The CMI shall publish a list of these notifie d standards, with their assignation to relevant 
measures, along with the measure of a general nature , in a manner available to the public (on the web-
site www.cmi.cz). 
Compliance with notified standards or parts thereof is considered to be, to the extent and under the 
conditions stipulated by a measure of a general nature, to be compliance with those requirements 
stipulated by this measure to which these standards or parts thereof apply. 
II. 
J U S T I F I C A T I O N 
The CMI issues, towards the implementation of Section 24c of Act No. 505/1990 Coll., on metrology, 
as amended, this measure of a ge neral nature, stipulating metrologi cal and technical requirements for 
specified measuring devices and test methods for verification of these specified measuring devices. 
In Decree No. 345/2002 Coll., specifying measuring devices for mandatory verification and measuring 
devices subject to type approval, as amended, the annex "List of Specified Measuring Device Types" 
classifies electronic medical and veterinary ther mometers under item 3.1.1 as measuring devices sub-
ject to verification. 
The CMI thus issues, towards the implementation of Section 24c of Act No. 505/1990 Coll., on me-
trology, as amended, for the measuring device type specified as "electronic medical and veterinary 
thermometers", this measure of a general nature, stipulating metrological and technical requirements 
for electronic medical and veterinary thermometers and test methods for verification of these specified measuring devices. 
  
III. 
E F F E C T I V E  D A T E 
This measure of a general nature takes effect on th e fifteenth day following the day of its publication 
(Section 24d of Act No. 505/1990 Coll., on metrology, as amended). 
This measure of a general nature shall be published for a time span of 15 days.