IS 15113: Clinical Electrical Thermometers with Maximum Device

15 Pages·2002·1.6 MB·English

by  Bureau of Indian Standards

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IS 15113 (2002): Clinical Electrical Thermometers with
Maximum Device [MHD 10: Medical Laboratory Instruments]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”

Is 15113:2002
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Indian Standard
CLINICAL ELECTRICAL THERMOMETERS WITH
MAXIMUM DEVICE — SPECIFICATION
ICS 11,040.55
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0 BIS 2002
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002

March 2002 Price Group 5
$A
-‘ Al.?
Medical Instruments and Disposable Sectional Committee, MHD 12
FOREWORD
This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized by the Medical
Instruments and Disposable Sectional Committee had been approved by the Medical Equipment and Hospital
Planning Division Council,
To formulate thisstandard, considerable assistancehasbeen derived from International Recommendation R-115
‘Clinical electrical thermometer with maximum device’ published by International Organization of Legal
Metrology (OIML) in 1995.
Clinical electrical thermometers indicate a maximum temperature measured after a steady state is reached or
predicted after atime specific to the design ofthe instrument. Until the maximum temperature isindicated, the
actual temperature may be indicated by the thermometer.
This specification does not exclude the use of any contact device based on other measurement principles that
meets equivalent performance standards indetermining maximum body temperature atspecified time intervals.
Clinical electrical thermometers designed to measure skin temperature and ovalution thermometers are not
covered under this specification.
For the purpose of deciding whether aparticular requirement of this standard iscomplied with, the final value,
observed orcalculated, expressing theresult ofatest, shallberounded off inaccordance with IS2: 1960‘Rules
forrounding offnumerical values (revised )’. The number ofsignificant places retained intherounded offvalue
should be the same asthat of the specified value inthis standard.
IS 15113:2002
Indian Standard
CLINICAL ELECTRICAL THERMOMETERS WITH
MAXIMUM DEVICE — SPECIFICATION
1SCOPE that monitors over a specified time the temperature
measured by aprobe incontact with abody cavity or
1.1 This standard specifies the metrological and
tissue, atwhich itindicates themaximum temperature
technical requirements for clinical electrical
and maintains the indication until reset by the user.
thermometers with a maximum device. Such
instruments aredesigned tomeasure human oranimal 2.6 Predicting Clinical Electrical Thermometer
body temperature.
Predicting clinical electrical thermometer calculates
1.2 This specification applies to battery-powered the maximum temperature of aprobe in contact with
instruments which provide a digital indication of a body cavity or tissue, without waiting for thermal
temperature.
equilibrium to occur, by using heat transfer data and
a mathematical algorithm.
2 TERMINOLOGY
3TYPES
2.1 Clinical Electrical Thermometer
A clinical electrical thermometer may be one of the
A clinical electrical thermometer, as covered by this
following types:
specification is a contact thermometer comprising a
temperature probe and an indicating unit, and that is Type 1 An interchangeable temperature probe
designed to measure human or animal body connected to an indicating unit that is
temperature. compatible with the characteristic response
oftheprobe.
2.2Temperature Probe
Type2 A temperature probe and an indicating unit
A temperature probe is the component of a thermo- permanently connected.
meter which isapplied toabody cavity ortissue with
4 REQUIREMENTS
which itestablishes thermal equilibrium. Itcomprises
.J
a temperature sensor with associated parts including 4.1 Metrological Requirements ---
coverage, seals, inner leads, and connecting plug,
where appropriate. 4.1.1 Unit of Measurement, Measuring Range and
Scale Interval

NOTES
1Abodyortissue maybethemouth(su blingual),rectum,or 4.1.1.1 The unit of temperature shall be the degree
armpit. Celsius (OC).
2Thepartoftheprobeincontactwithabodycavityortissueis
calledthe’appliedpart’. 4.1.1.2 The measurement range shall be a minimum
of35to43°Cor35to42”C.Greater measuring ranges
2.3 Reference Temperature may be sub-divided into partial ranges; however, the
range 35 to 42°C shall be continuous. Two accuracy
The reference temperature is that indicated (either
classes, Class I and Class II are covered by this
before the test, or before and after the test, as
specification.
appropriate) by the thermometer probe immersed in
the reference water bath according to Annex A, the 4.1.1.3 The scale interval or digital increment shall
temperature being held constant within the working not exceed:
range of the thermometer.
a) 0.01“Cfor Class I thermometers, and
2.4 Indicating Unit b) O.l°C for Class II thermometers.
An indicating unit isthecomponent ofathermometer
4.1.2 Maximum Permissible Errors
thatprocess theoutput signalofthetemperature sensor
and displays the measured temperature. 4.1.2.1 The maximum permissible error under
reference conditions for the temperature range 32.0
2.5 Maximum Device to 42.O”Cfor the two accuracy classes covered shall
beasfollows.
Amaximum deviceisthecomponent ofathermometer

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IS 15113:2002
sufficienttoprevent achangeinindicatedtemperatures
Accuracy Complete Indicating Temperature
greater than +0.02°C when the probe is immersed in
Class Thermometer Unit Probe
anelectrically conducting liquid having an insulation
Class I + 0.15°C * 0.05°C + O.l”c resistance of 80Mfl at20”C.This insulation includes
Class II * 0.2°C + O.l”c + O.l”c that between the inner lead wires, that between the
wires and the surface of the probe, and that encasing
and protecting connections and transitions.
4.1.2.2 Outside thetemperature range 32to42”C, the
4.2.1.4 The locations ofthe sensors inthe probe shall
maximum errors shall beattwice the values specified
be such that, when the probe is immersed to depths
in 4.1.2.1.
greater than 50 mm from its tip in a reference water
4.1.3 Reference Conditions bath, the temperature does not vary by more than
0.05°C from that indicated at adepth of 50 mm.
Thereference conditions fortherequirements of4.1.2
shall be: 4.2.1.5 Theprobe shallbestrong enough towithstand
mechanical stressesexpected under normal conditions
a) ambient temperature of 27 * 5°C,
ofthe use.
b) relative humidity of 50 + 20 percent, and
4.2.1.6 Iftheprobe isinterchangeable, itshallbefitted
c) theinstrument operating within thespecified
witheither aplug-in orquick disconnectable electrical
range of battery voltage (specified power
connector. The contact resistance of the connector or
supply conditions). *
the insulation resistance between the circuits of the
/
4.1.4 Time Response connector or to ground shall not cause a variation in
the indicated temperature greater than 0.02”C. :
The thermometer shall be submitted by the manu-
facturer to a testing laboratory to determine its time NOTE—Theconnectorsmaynotberequiredtobewaterresist-
ant.
response. The test shall bebased on any analysis of a
significant sample of human subjects, 4.2.1.7 The probe shall meet the requirements for
maximum permissible errors specified in 4.1.2 when
The difference between the displayed calculated
the applied part has been subjected to the cleaning )
temperature and the corresponding measured
and disinfecting procedure specified in Annex B.
temperature at thermal equilibrium of a calculating
(predicting) thermometer shall not exceed 0.2”C. NOTES
1Forsmallcompactthermometersthisappliestothecomplete “.- <
The description of this testis given inAnnex D. instnsment. .
..$
2Thematerialsoftheprohethatcomeintocontactwiththebody
4.2 Technical Requirements shouldbeselectedforcompatibilitywithbodytissue.
i
4.2.1 Temperature Probe 4.2.1.8 The output signal of the probe shall not vary 4

by more than *0.05°C when the temperature of the
4.2.1.1 For aninterchangeable probe oftheresistance
cableconnecting ittoanindicating unitvariesby20”C.
type, the manufacturer shall specify the maximum
power that may be suppried to the probe by an 4.2.2 Indicating Unit
indicating unit; this power shall not cause energy
4.2.2.1 When connected to a resistance-type
dissipation (PR) giving rise to any increase in
temperature probe, the indicating unit shall provide
temperature by more than 0.02°C when immersed in
anenergizing potential sufficiently low sothat energy
a reference water-bath maintained at a temperature
dissipation (PR) in the probe shall not cause an
range of 36.9 to 37.1°C.
increase inindicated temperature ofover 0.01“Cwhen
NOTES the probe is immersed in a reference water-bath at a
1Foradescriptionofthereferencewater-bath,seeAnnexA. temperature within the specified measuring range.
2Atestofthisrequirementisonlyapplicabletointerchangeable
probessubmittedforpatternapprovalwithoutaspecificindicating 4.2.2.2 The indicating unit shall not indicate a
unit.Whenaprobeissubmittedwithanassociatedindicatingunit, temperature when connected to abattery charger.
therequirementin4.2.2.1applies.
4.2.2.3 The digital display of temperature shall be at
4.2.1.2 The thermal stability of the probe, after
least4mm inheight or itshall be optically magnified
exposure for 100h at 80* 2°C or 300 hat 55+2“C,
so as to appear at least 4 mm in height.
shall be such that the requirement for maximum
permissible errors specified in 4.1.2 ismet. 4.2.2.4 The indicating unit shall provide a clear
indication or warning signal when the measured
4.2.1.3 The electrical insulation of the probe shall be
temperature isoutside the specified measuring range.

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IS 15113:2002 —
4.2.2.5 The indicating unit shall include a self- and labels.
checking device that meets the requirements of4.1.2. ;V’
5.1.2 Manufacturers shall affix on the thermometer
This device, which may bemanual orautomatic, shall
or indicating unit, if separate, the following marks or
input a predetermined electrical signal. Failure shall
labels:
be clearly indicated.
,...
a) Name and address of manufacturer or
NOTE—Thisdevicechecksonlytheoperationoftheindicating
supplier, and/or trade-mark;
unitanddoesnotensurethatatemperaturemeasurementiscorrezt. ,,
Itprovidesameansofdetectingafaultyoperationscausedbya b) Model or type designation; [
defectivecomponentorotherdisturbance.
c) A code number to trace the batch of
4.2.2.6 In the case of a predicting thermometer, the manufacturer;
,
indicating unit shall provide a means of displaying
d) Temperature values or indications given by
the measured temperature after reaching the thermal
the self-checking device;
i
equilibrium.
e) Indication of the orientation or position in
4.2.3 Complete Thermometer sue, where appropriate; and
o Indication if a displayed value is calculated.
4.2.3.1 The thermometer shall provide a clear
indication orwarning signal when thebattery voltage 5.1.3 Interchangeable temperature probes shall bear
is outside the specified limits and it shall meet the the following marks or labels:
requirement specified in 4.1.2 when the voltage is
a) Name and address of manufacturer and/or
within these limits.
trade-mark,
4.2.3.2 The indicated temperature shall not vary by
b) Type designation, and
more than +0.1‘C from the reference temperature
c) A code number to trace the batch of
whenthetemperature ofthethermometer casingvaries
manufacture.
from 10to 40°C.
5.1.4 A single-use temperature probe shall be sealed
4.2.3.3 The indicated temperature shall not vary by
in a package on which the information specified
morethan+0.1‘C fromthereference temperature after
in 5.1.3 and the measuring range shall be indicated.
a thermal shock resulting from an abrupt change in
In addition, sufllcient space on the package shall be
temperature from –5 to +50°C.
provided fortheapplication ofofficial approval marks.
4.2.3.4 The indicated temperature shall not vary by It shall be clear if the package has been opened and
morethan*O.10Cfromthereference temperature after theinstructions shall stipulate thattheuser only opens
storage for 24 h at–20 * 2°C and at 60 * 2“C. thepackage immediately before use.
4.2.3.5 The indicated temperature shall not vary by 5.1.5 The testing laboratory shall permit the

morethan*O.1‘Cfromthereference temperature after application in aconspicuous place, of the following:

storage at a relative humidity of 91 percent to
a) Pattern approval mark or label, on each
95percent at a temperature constant within+ 2°C in
complete thermometer or indicating unit and
the range 20 to 32”C.
associated temperature probe(s).
4.2.3.6 The indicated temperature shall not vary by b) Indication of the specified temperature’
more than + 0.3°C from the reference temperature measuring range if the total range of the
during exposure to electromagnetic field having a thermometer is greater.
frequency between 150kHz and 500MHz andafield
strength of 10V/m. 5.2 Packing
4.2.3.7 The indicated temperature shall not vary by 5.2.1 Clinical electrical thermometer shall be packed
morethan+0.1“Cfromthereference temperature after individually orcollectively, inany manner acceptable
fall on to a hard surface from a height of lm from tothepurchaser, soastominimize therisk ofdamage
three different orientations. in handling, transport and storage.
4.2.3.8 Small and compact complete thermometers 5.2.2 Manufacturers shall provide an operating
shall be water resistant. manual, or instructions, including the following
information:
5NIARKING AND PACKING
a) Description of appropriate uses and means
5.1 Marking of applications;
b) Identification of the specified temperature
5.1.1 Manufacturers shall provide a space for marks
measuring range of the complete

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IS 15113:2002
thermometer taking into account, if 6TESTS
applicable, thespecified measuring ranges of
6.1Thermometers shall be subjected to the following
both the interchangeable probes and the
tests.
indicating unit;
c) Instructions andprecautions forcleaning and NOTE—Requirementsforthereferencewater-bathandthetest
formaximumpermissibleerrorsareprovidedinAnnexA.The
disinfecting thecomplete thermometer orthe
performance requirements for the instrument and its major
interchangeable probes; componentsareprovidedin4.1and4.2.Whereappropriate,an
additionaldescriptionofrequiredtestsisprovidedinAnnexB.
d) Identification of components and suitable
interchangeable parts such as probes and 6.1.1 Probe
batteries, including nominal voltage, if
a) Maximum permissible errors (see 4.1.2 and
applicable;
Annex A),
e) Minimum time for achieving thermal
b) Long-term thermal stability (see 4.2.1.2),
equilibrium;
c) Electrical insulation and water resistance
o Description of transition from the predicted (see 4.2.1.3 and Annex B),
temperature-measuring mode into the actual
d) Location of sensor (see 4.2.1.4),
temperature-measuring mode;
e) Mechanical strength (see 4.2.1.5),
g) Instruction for the self-checking device;
f) Electrical contact resistance of connector
h) Information on the correct environmental
(see 4.2.1.6),
conditions of use, storage, and transport of
the thermomete~ and !3) Cleaning and disinfecting (see 4.2.1.7 and
Annex B), and
j) Specific information should be provided by
h) Stability with changes in temperature of
the manufacturer, on request, regarding
cables (see 4.2.1.8).
possible sub-standard performance if used
under the following conditions: 6.1.2 Indicating Unit
1) Outside the prescribed environmental
a) Maximum permissible errors (see 4.1.2 and
temperature and humidity range, and
Annex A),
2) After an accidental mechanical shock.
b) Power provided to probe (see 4.2.2.1 and
5.2.3 For pattern evaluation the manufacturer shall
Annex B),
provide the following information:
c) Indication when connected tobattery charger
a) Location of sensor from tip ofprobe; (see 4.2.2.2),
b) Description and principles of measurement d) Indication if the thermometer is outside the

of complete thermome ter; specified measuring range (see 4.2.2.4),

c) Description ofelectricalprinciples andofany e) Self checking device (see 4.2.2.5), and
necessary equipment provided; 0 Display of predicting thermometer (see
d) Description of test for self-checking device; 4.2.2.6j. -
e) Specified working range forbattery;
6.1.3 Complete Thermometer
8 Nominal and specified temperature
a) Maximum permissible errors (see 4.1.2 and
measuring ranges;
Annex A);
g) Nominal values of calibrations data for type
b) Low battery indication (see 4.2.3.1 and
of temperature probe, as applicable;
Annex B);
h) Precautions for cleaning and disinfecting
c) Ambient temperature (see 4.2.3.2 and
complete thermometer ortemperature probes,
Annex B);
as appropriate, including test results as
specified inAnnex B; d) Thermal shock (see 4.2.3.3 and Annex B);
j) Indication on instrument ifadisplayed value e) Storage temperatures (see 4.2.3.4);
is calculated; o Humidity (see 4.2.3.5 and Annex B);
k) Test results; g) Electromagnetic radiation interference
m) Results of clinical test of time responses (see 4.2.3.6 and Annex B);
(see 4.1.4 and Annex D); and h) Mechanical shock (see4.2.3.7 andAnnex B);
n) Operating manual and/or instructions j) Water resistance of small compact
(see 5.2.2), thermometers (see 4.2.3.8 and Annex C);

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Is 15113:2002
k) Instructions andprecautions forcleaning and provided by manufacturers as specified in 5.2.2.
disinfecting thecomplete thermometer orthe
6.2.2 The laboratory shall examine the instrument’s
interchangeable probes;
pattern approval certificate mark(s) or label(s).
m) Identification of components and suitable
interchangeable parts such as probes and 6.2.3 The laboratory shall carry out any of the tests
batteries, including nominal voltage, if indicated in6.1that maybe critical forthedesignated
applicable; and application of the instrument.
n) Minimum time for achieving thermal NOTE—ThetestsindicatedinAnnexAmaybe sufficientfor
equilibrium by an indicating energy verification.
dissipation requirements (see 4.2.1.1 and
6.2.4 The laboratory shall provide a verified
Annex B).
instrument with a mark or label.
A report of the results of tests required shall be
6.2.5 The water resistance of small and compact
prepared.
complete thermometers shall be examined by means
of the procedure described inAnnex C.
6.2Verification
6.2.6 The laboratory shall indicate the period of
6.2.1 The laboratory shall examine the information
validity of the verification.
ANNEX A
(Clause 2.3)
ESTABLISHING REFERENCE TEMPERATURES AND
DETERMINING MAXIMUM PERMISSIBLE ERRORS
A-1 REFERENCE TEMPERATURES thermometer shall be immersed in areference water-
A-1.l A well-regulated and stirred water-bath bath at a constant temperature until temperature .}
containing at least one litre in volume shall be used equilibrium isestablished. The temperature indicated .- ‘.!i
bythethermometer shallbecompared tothatindicated
to establish reference temperatures over the , .
by the reference thermometer. The bath temperature ,4
measuring range forconducting various performance
shall then be increased or decreased, the temperature
tests on an instrument. The bat h shall be controlled
equilibrium re-established, and the measurement
toatemperature stability ofbetter t han* 0.02°C over
processrepeated.Thedifference between themeasured
the specified temperature range and shall not have a
and reference temperatures shall meet the
temperature gradient greater than +0.01“Cwithin its
requirements for maximum permissible errors as
working space at a specified temperature. This
specified in 4.1.2.
temperature gradient shall be assured under all
conditions and methods of loading temperature A-2.1.2 The number of measurements at different
probes. temperatures depends on the measuring range of the
instrument; however, measurements shall be carried
NOTE— The water-bath described aboveisreferredtoasa
‘referencewater-bath’inthisspecification. out for at least the following number of temperatures
within the measuring range:
A-1.2 A reference thermometer with an expanded
uncertainty no greater than 0.03°C (calculated for a Measuring Range Number of Temperatures
coverage factor k= 3) shall be used to determine the
<1 O“c 3
temperature of the water-bath. The calibration shall
be traceable to national measurement standards. >1O”C 5
A-2DETERMINING MAXIMUM PERMISSIBLE A-2.2 Interchangeable and Single-Use Probe
ERRORS
A-2.2.1 An interchangeable or single-use probe shall
be immersed inareference water-bath asspecified in
A-2.1 Complete Thermometer
AnnexAmeasuredphysicalproperty oftheprobeshall
A-2.1.1 The temperature probe of a complete be converted to a temperature value by using an

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