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Activities in the field of legal metrology and standardisation of clinical

thermometers

Conference Paper · January 2004

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 ACTIVITIES IN THE FIELD OF LEGAL METROLOGY AND
STANDARDISATION OF CLINICAL THERMOMETERS
J. Hartmann and E. Tegeler

Physikalisch-Technische Bundesanstalt (PTB), Braunschweig und Berlin, Berlin, Germany

ABSTRACT

Recently the CEN/TC 205/WG 12 Clinical Thermometer has finalised the European standard on clinical
thermometers, EN 12470, by implementing the part 5 Clinical thermometers — Performance of infra-red ear
thermometers (with maximum device). This last part of the EN 12470 series is dealing with the performance
and requirements for infrared ear thermometers. The other four parts are dealing with metallic liquid-in-glass
thermometers, phase change-type (dot matrix) thermometers, compact electrical thermometers (non-predictive
and predictive), and electrical thermometers for continuous measurement.

Beside this European standard there are national standards dealing with clinical thermometers, the most
important in the USA and in Japan. In the field of legal metrology there are three OIML recommendations on
clinical thermometers, covering the field of mercury-in-glass thermometers (R7), electrical thermometers for
continuous measurements (R114), and electrical thermometers with maximum device (R 115).

To ensure further harmonisation in the field of clinical thermometers it is planned to elaborate joint ISO/IEC-
OIML standards based on the existing standards and recommendations. The paper reviews the existing
standards and recommendations in the field of clinical thermometers and gives an outlook on the work
planned to elaborate a joint ISO/IEC-OIML standard.

1. INTRODUCTION

Human body temperature is an important and frequently measured parameter in clinical diagnosis.
Until some decades ago the only measurement instrument for body temperature was the mercury-
in-glass thermometer with maximum device. The requirements for its application has been subject
to legal metrology in many countries for more than a century. In the last decades several new types
of medical thermometers have been developed and are now in use in medical applications, most
prominent among them compact electrical thermometers and infra-red (IR) ear thermometers.

Due to its significance requirements on devices for clinical temperature measurement are subject
to national and international standardisation and recommendation. These standards have an
enormous economic impact, because also thermometers from other countries have to fulfil the
requirements defined by these standards. Therefore national standards may result in trade
impediments and are not supporting a global economy. The international standard organisations
ISO and IEC and the international organisation for legal metrology OIML therefore have
established committees and working groups that are responsible for such standards, but up to now
no worldwide accepted standard does exist for clinical thermometers.

2. EXISTING STANDARDS AND RECOMMENDATIONS

As in several countries medical thermometers are not or no longer subject to legal metrology and,
therefore, are no longer coverd by OIML recommendations, regional or national standards have
been implemented. The European Committee for Standardisation (CEN) decided to standardise the
requirements on devices for clinical temperature measurement, leading to the EN 12470 Clinical
Thermometers, consisting of 5 parts for different types of thermometers. Besides the European
standard there exist a variety of standards on clinical thermometers, the most important in the USA
and in Japan. In other regions clinical thermometers are still subject to legal metrology: examples
are Eastern European countries or countries in Latin America. Smaller countries even do not have
the capacity to draft their own standards. Besides the national or regional standards mentioned
above therefore international OIML recommendations are used in several countries. Table 1 gives
an overview on the most important standards.

Table1: Existing standards on medical thermometers

Type of thermometer OIML European EN US ASTM Japanese JIS
Liquid-in-glass R7 (1979) 12470-1:99 E667:98 T 4206:89
Electrical thermometer with R115 (1995) 12470-3:99 E879:01 T 1140:98
maximum device
Electrical thermometer for R114 (1995) 12470-4:00 E1112:00 T 1306:89
continuous meas.
IR ear thermometers 12470-5:03 E1965:98 T xxxx:04
Phase change-type 12470-2:99 E825:98
thermometers E1299:02
Probe covers and sheaths E1104:98

All these existing standards obviously seem to fulfil the basic requirements for medical
applications, because no casualties due to wrong temperature measurements are known. Moreover,
the main contribution to the uncertainty of the measurement of the human body temperature is
caused from the application of the thermometer by the physician or the patient. As a result, the
standards are based not only on clinical requirements, but are strongly influenced by economic
interests, state of the technology and the tradition in metrology. As an example, the most important
deviations in the requirements for liquid-in-glass thermometers between EN 12470-1:99 and
ASTM E667:99 are listed in Table 2.

Table 2: Different requirements in European and US standards for medical liquid-in-glass

thermometers
EN 12470-1:99 ASTM E667:98
Unit °C °C or °F
Types Metallic liquid-in-glass, with maximum Mercury-in-glass, with maximum
device, Solid stem or enclosed scale device, Solid stem
Range of scale 35.5 °C to 42.0 °C 35.5 °C to 41.0 °C
Maximum per- +0.1 °C, -0.15 °C <35.8 °C: 0.3 °C;
missible error 35.8 °C to <37.0 °C: 0.2 °C
37.0 °C to 39.0 °C: 0.1 °C
>39.0 °C to 41.0 °C: 0.2 °C
>41.0 °C: 0.3 °C
“Reset” of reading No regulation Acceleration (500 ± 20) m/s2
Temperature point 2 temperatures, 4 °C apart in the range Tests at 3 temperatures:
for verification 35.5 °C to 42 °C 37 °C, 39 °C, and 41 °C
Break force Break force >50 N (only enclosed scale No regulation
thermometers)
Influence of Identical reading in water bath after 20 s No regulation
immersion time and 60 s immersion within 0.006 (t2 – t1)
While from a metrological viewpoint the differences in the requirements may be only of minor
importance, the economic impact is severe: medical thermometers produced for the US market are
not to be used in Europe and vice versa. This may not be a major problem for mercury-in-glass
thermometers, because thermometers with mercury are already or will be forbidden in the near
future by several countries for environmental reasons. But it is important to allow for alternative
thermometric liquids as has already be done in the European standard. Up to now no organic liquid
has been found that can be used in combination with a maximum device in liquid-in-glass
thermometer, but it has to be discussed if a standard should leave this question open or not. For
these and other reasons standards and recommendation are always subject to revision, typically
with a period of 5 to 10 years. From the date of the last revision given in Table 1 it can be seen that
for several standards a revision is due in the near future or already overdue.

3. PLANS FOR INTERNATIONAL STANDARDS AND RECOMMENDATIONS

The OIML recommendations are now considered for revision and also some of the international
standards described above are thought to be revised in near future. To further coordinate the
international requirements on clinical thermometers it is planned to harmonize the national and
international standards and recommendations by forming a joint ISO/IEC-OIML working group on
clinical thermometers. The aim of this working group is the implementation of a joint ISO/IEC-
OIML standard on clinical thermometers. This is particular interesting, because there are several
countries where clinical thermometers are no longer subject to legal metrology. It is demanding
that these international standards consider the OIML needs and exisiting OIML recommendations.
OIML in general supports the idea of joint ISO/IEC-OIML standards or recommendations, and an
example of such successful joint work can be found in the ISO 3930/OIML R99 covering the field
of vehicle exhaust measurement [1]. In the field of blood pressure measurements a similar
approach as indicted in the present paper has already started recently. It is challenging but highly
desirable to achieve such general standards /recommendations also in the field of medical
thermometers.

The first step for such standards would be the definition of the essential requirements for each type
of clinical thermometer. In Europe, the essential requirements for medical devices, and therefore
also for clinical thermometers, are laid down in the EU Council directive 93/42/EEC of 14 June
1993 concerning medical devices, which have been implemented into national laws in the mean
time. Every medical device, therefore also clinical thermometer, has to fulfil these essential
requirements. To specify the essential requirements and to specify calibration procedures
especially for clinical thermometers the EN 12470 series of standards for clinical thermometer has
been formulated. The situation in other regions of the global market is or may be different from the
situation in Europe. Therefore a survey of existing essential requirements and standards
/recommendations will be necessary before drafting a new ISO/IEC-OIML standard.

Harmonized standards for medical products in the meaning of the medical device directive in
Europe represent the state of the art of the present technique and can, therefore, be seen as a
guideline for manufactures for the essential requirements of those medical devices. For this reason
it is essential that besides experts in (legal) metrology also manufacturers and best also
professional users are represented in the working group that will draft the recommendation. It goes
without saying that members from different countries should participate in the work of the group.
OIML TC18 SC2 (responsible for medical thermometers) has already asked for and found
volunteers for the work. Within ISO or IEC the responsible working group still has to be defined.
Due to the good experience with the present work in the field of blood pressure measurements, the
same working groups, ISO/TC 121/SC 3 and IEC TC/SC 62D may be used also for the field of
clinical thermometers. A final decision will happen in the near future, because the European
stadardisation organisation CEN has already started to prepare a new work item proposal for an
ISO/IEC standard for clinical thermometers.

The new international standard will probably be drafted in several parts. Most important for OIML
would be a recommendation on IR ear thermometers, because up to now no such recommendation
exists. Moreover, it seems that the existing standards for IR ear thermometers are quite similar and
industries and verification offices are still open to new proposals, because the subject does not
have a tradition over several decades.

3. STANDARDS FOR IR EAR THERMOMETERS

IR ear thermometers have been introduced more than a decade ago as clinical thermometers. They
have some advantages compared to contact thermometers: The response time is in the order of 1 s,
and the temperature of the ear is in most cases close to the core body temperature. The IR ear
thermometer measures the core body temperature by sensing the thermal radiation emitted by the
tympanum and the ear canal. During the measurement the sensing tip of the IR ear thermometer is
inserted into the ear canal, which, to a good approximation is a blackbody radiator. On the other
hand clinical tests have shown up also disadvantages: dirt on the entrance windows leads to
systematically wrong measurements, and the angle between the thermometer and the symmetry
axis of the ear is quite critical. In the last few years the price of ear thermometers has decreased to


   



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the level of about 25
patients at home. Recommendations and standards on the requirements that are to be fulfilled by
ear thermometers are therefore urgent.

For metrological test of IR ear thermometers a standard reference blackbody source has been
developed by the PTB. Figure 1 shows a picture and a schematics of the easy to operate standard
reference blackbody.

110 mm
20 mm
5 mm

3 2
105 mm

4
30°
wall thickness
1,5 mm

a) 39 mm b)
Figure 1: Schematic drawing (a) and photograph (b) of the reference bath blackbody radiator for the calibration of IR ear
thermometers [2]. (1 mount, 2 black paint (εW>0.95), 3 aperture, 4 O-ring)

This highly specialised blackbody has been implemented in the Annex C of the EN 12470-5 [2] as
a recommendation for a simple traceable calibration of IR ear thermometers. The cavity is
immersed in a temperature controlled water bath with a minimum volume of 3 l, which according
to the EN 12470-5, has to fulfil the following specifications: a temperature stability within 0.02 °C
over a time period of one hour and a spatial temperature uniformity within 0.01 °C. The
temperature of the cavity is sensed by an SPRT immersed in the water and located close to the
bottom of the copper cavity. If the SPRT is calibrated traceable to the ITS-90 with an extended
standard uncertainty U < 30 mK (k=2), the temperature reading of this SPRT can directly be used
for the traceable measurement of the radiation temperature of the IR ear thermometer blackbody in
accordance with the EN 12470-5.

Standards on IR ear thermometers already exist in Europe, the USA and in Japan. The different
requirements in these standards are summarised in Table 3. In general the requirements in all
standards are quite similar. The largest deviation is in the scope of the standards. It is not only a
bureaucratic question if skin thermometers should be included in the standard or not, but the basic
question is if skin thermometers can be accepted as measurement devices for the estimate of the
body temperature at all. For the decision of this point clinical tests would be helpful. Unfortunately
physicians are not really interested in the technique of temperature measurement: they believe that
all types of thermometers give “true” results, whatever this means. Therefore most standardisation
committees consist of manufacturers and metrologists, but no physician participates in the work.
Nevertheless, the resulting standards for medical thermometers usually fulfil the clinical require-
ments and improve the rights of the clients and patients.

Based on the close agreement of the existing standards, it can be expected that an international
standard on IR ear thermometers can be drafted in the near future. This standard would be the first
part of an international standard covering all (or at least most) types of medical thermometers.

Table 3: Different requirements in European, US, and Japanese standards for IR ear thermometers
EN 12470-5:03 ASTM E 1965 - 98 JIS T xxxx:04
Scope IR ear thermometer, instruments for detecting the in- IR ear thermometer; IR
also devices that only tensity of thermal radiation bet- skin thermometer are
measure tympanic ween subject of measurement and explicitly excluded
membrane temperature sensor, i.e. IR ear and skin
thermometer
Unit °C - -
Range of dis- 35.5 °C - 43.0 °C 34.4 °C - 42.2 °C 35.5 °C - 43.0 °C
played
temperatures.
for IR skin - minimum: -
thermomete 22 °C - 40.0 °C
r
Clinical <0.3 °C - -
repeatability
Clinical defined in appendix defined in standard defined in appendix
accuracy
ambient temp.: +16 °C to +35 °C temp.: +16 °C to +40 °C temp.: +16 °C to +35 °C
operating rH: ≤ 85 % (non rH: ≤ 95 % (non condensing) rH: 35 % - 75 %
conditions condensing) (non condensing)
electro- EN 60601-1-2 explicit test procedure IEC 60601-1-2,
magnetic no explicit test procedure IEC 61000-4-3
compatibility CISPR11, explicit test
procedure
reference radiance temperature true temperature of blackbody traceable to national
blackbody better than 0.07 °C (k=2) measured by immersed measurement standard
NMI or competent thermometer with uncertainty no explicit uncertainty for
laboratory, better to 0.03 °C, temperature given,
design recommended in design recommended in appendix, design recommended in
appendix appendix
 REFERENCES

[1] Athané B., ISO BULLETIN, 2000, 17-18

[2] European Standard EN 12470-5:2003

Addresses of the Authors:

Jürgen Hartmann, Section High-temperature radiation thermometry, Erich Tegeler, Section Applied
Thermometry, Physikalisch-Technische Bundeanstalt, Braunschweig und Berlin, Abbestraße 2-12, 10587
Berlin, Germany, dr.j.hartmann@ptb.de, Erich.Tegeler@ptb.de.

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