Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

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“Invent a New India Using Knowledge”

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“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS 15113 (2002): Clinical Electrical Thermometers withMaximum Device [MHD 10: Medical Laboratory Instruments]

Is 15113:2002

mm@-fa=l-aa-3TR*W1-qfaazla

Indian Standard

CLINICAL ELECTRICAL THERMOMETERS WITHMAXIMUM DEVICE — SPECIFICATION

ICS 11,040.55

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0 BIS 2002

BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

March 2002 Price Group 5

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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 MedicalInstruments and Disposable Sectional Committee had been approved by the Medical Equipment and HospitalPlanning Division Council,

To formulate this standard, considerable assistance has been derived from International Recommendation R- 115‘Clinical electrical thermometer with maximum device’ published by International Organization of LegalMetrology (OIML) in 1995.

Clinical electrical thermometers indicate a maximum temperature measured after a steady state is reached orpredicted after a time specific to the design of the instrument. Until the maximum temperature is indicated, theactual temperature may be indicated by the thermometer.

This specification does not exclude the use of any contact device based on other measurement principles thatmeets equivalent performance standards in determining maximum body temperature at specified time intervals.

Clinical electrical thermometers designed to measure skin temperature and ovalution thermometers are notcovered under this specification.

For the purpose of deciding whether a particular requirement of this standard is complied with, the final value,observed or calculated, expressing the result of a test, shall be rounded off in accordance with IS 2: 1960 ‘Rulesfor rounding off numerical values (revised )’. The number of significant places retained in the rounded off valueshould be the same as that of the specified value in this standard.

IS 15113:2002

Indian Standard

CLINICAL ELECTRICAL THERMOMETERS WITHMAXIMUM DEVICE — SPECIFICATION

1 SCOPE

1.1 This standard specifies the metrological andtechnical requirements for clinical electricalthermometers with a maximum device. Suchinstruments are designed to measure human or animalbody temperature.

1.2 This specification applies to battery-poweredinstruments which provide a digital indication oftemperature.

2 TERMINOLOGY

2.1 Clinical Electrical Thermometer

A clinical electrical thermometer, as covered by thisspecification is a contact thermometer comprising atemperature probe and an indicating unit, and that isdesigned to measure human or animal bodytemperature.

2.2 Temperature Probe

A temperature probe is the component of a thermo-meter which is applied to a body cavity or tissue withwhich it establishes thermal equilibrium. It comprisesa temperature sensor with associated parts includingcoverage, seals, inner leads, and connecting plug,where appropriate.

NOTES

1 A body or tissue may be the mouth (sublingual), rectum, orarmpit.

2 The part of the probe in contact with a body cavity or tissue iscalled the’ applied part’.

2.3 Reference Temperature

The reference temperature is that indicated (eitherbefore the test, or before and after the test, asappropriate) by the thermometer probe immersed inthe reference water bath according to Annex A, thetemperature being held constant within the workingrange of the thermometer.

2.4 Indicating Unit

An indicating unit is the component of a thermometerthat process the output signal of the temperature sensorand displays the measured temperature.

2.5 Maximum Device

A maximum device is the component of a thermometer

that monitors over a specified time the temperaturemeasured by a probe in contact with a body cavity ortissue, at which it indicates the maximum temperatureand maintains the indication until reset by the user.

2.6 Predicting Clinical Electrical Thermometer

Predicting clinical electrical thermometer calculatesthe maximum temperature of a probe in contact witha body cavity or tissue, without waiting for thermalequilibrium to occur, by using heat transfer data anda mathematical algorithm.

3 TYPES

A clinical electrical thermometer may be one of thefollowing types:

Type 1 An interchangeable temperature probeconnected to an indicating unit that iscompatible with the characteristic responseof the probe.

Type 2 A temperature probe and an indicating unitpermanently connected.

4 REQUIREMENTS

4.1 Metrological Requirements

4.1.1 Unit of Measurement, Measuring Range andScale Interval

4.1.1.1 The unit of temperature shall be the degreeCelsius (OC).

4.1.1.2 The measurement range shall be a minimumof 35 to 43°C or 35 to 42”C. Greater measuring rangesmay be sub-divided into partial ranges; however, therange 35 to 42°C shall be continuous. Two accuracyclasses, Class I and Class II are covered by thisspecification.

4.1.1.3 The scale interval or digital increment shallnot exceed:

a) 0.01 “C for Class I thermometers, and

b) O.l°C for Class II thermometers.

4.1.2 Maximum Permissible Errors

4.1.2.1 The maximum permissible error underreference conditions for the temperature range 32.0to 42.O”C for the two accuracy classes covered shallbe as follows.

.J

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IS 15113:2002

Accuracy Complete Indicating TemperatureClass Thermometer Unit Probe

Class I + 0.15°C * 0.05°C + O.l”c

Class II * 0.2°C + O.l”c + O.l”c

4.1.2.2 Outside the temperature range 32 to 42”C, themaximum errors shall be at twice the values specifiedin 4.1.2.1.

4.1.3 Reference Conditions

The reference conditions for the requirements of 4.1.2shall be:

a) ambient temperature of 27 * 5°C,

b) relative humidity of 50 + 20 percent, and

c) the instrument operating within the specifiedrange of battery voltage (specified powersupply conditions).

4.1.4 Time Response

The thermometer shall be submitted by the manu-facturer to a testing laboratory to determine its timeresponse. The test shall be based on any analysis of asignificant sample of human subjects,

The difference between the displayed calculatedtemperature and the corresponding measuredtemperature at thermal equilibrium of a calculating(predicting) thermometer shall not exceed 0.2”C.

The description of this testis given in Annex D.

4.2 Technical Requirements

4.2.1 Temperature Probe

4.2.1.1 For an interchangeable probe of the resistancetype, the manufacturer shall specify the maximumpower that may be suppried to the probe by anindicating unit; this power shall not cause energydissipation (PR) giving rise to any increase intemperature by more than 0.02°C when immersed ina reference water-bath maintained at a temperaturerange of 36.9 to 37.1°C.

NOTES

1 For a description of the reference water-bath, see Annex A.

2 A test of this requirement is only applicable to interchangeableprobes submittedfor patternapprovalwithouta specificindicatingunit. When a probeissubmittedwith an associatedindicatingunit,the requirement in 4.2.2.1 applies.

4.2.1.2 The thermal stability of the probe, afterexposure for 100 h at 80 * 2°C or 300 h at 55 + 2“C,shall be such that the requirement for maximumpermissible errors specified in 4.1.2 is met.

4.2.1.3 The electrical insulation of the probe shall be

---d

sufficient to prevent a change in indicated temperaturesgreater than +0.02°C when the probe is immersed inan electrically conducting liquid having an insulationresistance of 80 Mfl at 20”C. This insulation includesthat between the inner lead wires, that between thewires and the surface of the probe, and that encasingand protecting connections and transitions.

4.2.1.4 The locations of the sensors in the probe shallbe such that, when the probe is immersed to depthsgreater than 50 mm from its tip in a reference waterbath, the temperature does not vary by more than0.05°C from that indicated at a depth of 50 mm.

4.2.1.5 The probe shall be strong enough to withstandmechanical stresses expected under normal conditionsof the use.

4.2.1.6 If the probe is interchangeable, it shall be fittedwith either a plug-in or quick disconnectable electricalconnector. The contact resistance of the connector or *the insulation resistance between the circuits of theconnector or to ground shall not cause a variation in /

the indicated temperature greater than 0.02”C. :

NOTE — The connectors may not be required to be water resist-ant.

4.2.1.7 The probe shall meet the requirements formaximum permissible errors specified in 4.1.2 whenthe applied part has been subjected to the cleaning )and disinfecting procedure specified in Annex B.

NOTES

1 For small compact thermometers this applies to the completeinstnsment.

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2 The materials of the prohe that come into contact with the body

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should be selected for compatibility with body tissue.

4.2.1.8 The output signal of the probe shall not vary 4by more than *0.05°C when the temperature of thecable connecting it to an indicating unit varies by 20”C.

4.2.2 Indicating Unit

4.2.2.1 When connected to a resistance-typetemperature probe, the indicating unit shall providean energizing potential sufficiently low so that energydissipation (PR) in the probe shall not cause anincrease in indicated temperature of over 0.01“C whenthe probe is immersed in a reference water-bath at atemperature within the specified measuring range.

4.2.2.2 The indicating unit shall not indicate atemperature when connected to a battery charger.

4.2.2.3 The digital display of temperature shall be atleast 4 mm in height or it shall be optically magnifiedso as to appear at least 4 mm in height.

4.2.2.4 The indicating unit shall provide a clearindication or warning signal when the measuredtemperature is outside the specified measuring range.

2 I

IS 15113:2002

4.2.2.5 The indicating unit shall include a self-checking device that meets the requirements of 4.1.2.This device, which may be manual or automatic, shallinput a predetermined electrical signal. Failure shallbe clearly indicated.

NOTE — This device checks only the operation of the indicatingunit anddoesnot ensurethat a temperaturemeasurementiscorrezt.It provides a means of detecting a faulty operations caused by adefective component or other disturbance.

4.2.2.6 In the case of a predicting thermometer, theindicating unit shall provide a means of displayingthe measured temperature after reaching the thermalequilibrium.

4.2.3 Complete Thermometer

4.2.3.1 The thermometer shall provide a clearindication or warning signal when the battery voltageis outside the specified limits and it shall meet therequirement specified in 4.1.2 when the voltage iswithin these limits.

4.2.3.2 The indicated temperature shall not vary bymore than +0. 1‘C from the reference temperaturewhen the temperature of the thermometer casing variesfrom 10 to 40°C.

4.2.3.3 The indicated temperature shall not vary bymore than + 0.1‘C from the reference temperature aftera thermal shock resulting from an abrupt change intemperature from –5 to +50°C.

4.2.3.4 The indicated temperature shall not vary bymore than *O.10C from the reference temperature afterstorage for 24 h at –20 * 2°C and at 60 * 2“C.

4.2.3.5 The indicated temperature shall not vary bymore than *O.1‘C from the reference temperature afterstorage at a relative humidity of 91 percent to95 percent at a temperature constant within+ 2°C inthe range 20 to 32”C.

4.2.3.6 The indicated temperature shall not vary bymore than + 0.3°C from the reference temperatureduring exposure to electromagnetic field having afrequency between 150 kHz and 500 MHz and a fieldstrength of 10 V/m.

4.2.3.7 The indicated temperature shall not vary bymore than + 0.1“C from the reference temperature afterfall on to a hard surface from a height of lm fromthree different orientations.

4.2.3.8 Small and compact complete thermometersshall be water resistant.

5 NIARKING AND PACKING

5.1 Marking

5.1.1 Manufacturers shall provide a space for marks

and labels.

5.1.2 Manufacturers shall affix on the thermometeror indicating unit, if separate, the following marks orlabels:

a)

b)

c)

d)

e)

o

Name and address of manufacturer orsupplier, and/or trade-mark;

Model or type designation;

A code number to trace the batch ofmanufacturer;

Temperature values or indications given bythe self-checking device;

Indication of the orientation or position insue, where appropriate; and

Indication if a displayed value is calculated.

5.1.3 Interchangeable temperature probes shall bearthe following marks or labels:

a) Name and address of manufacturer and/ortrade-mark,

b) Type designation, and

c) A code number to trace the batch ofmanufacture.

5.1.4 A single-use temperature probe shall be sealedin a package on which the information specifiedin 5.1.3 and the measuring range shall be indicated.In addition, sufllcient space on the package shall beprovided for the application of official approval marks.It shall be clear if the package has been opened andthe instructions shall stipulate that the user only opensthe package immediately before use.

5.1.5 The testing laboratory shall permit theapplication in a conspicuous place, of the following:

a) Pattern approval mark or label, on eachcomplete thermometer or indicating unit andassociated temperature probe(s).

b) Indication of the specified temperature’measuring range if the total range of thethermometer is greater.

5.2 Packing

5.2.1 Clinical electrical thermometer shall be packedindividually or collectively, in any manner acceptableto the purchaser, so as to minimize the risk of damagein handling, transport and storage.

5.2.2 Manufacturers shall provide an operatingmanual, or instructions, including the followinginformation:

a) Description of appropriate uses and meansof applications;

b) Identification of the specified temperaturemeasuring range of the complete

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IS 15113:2002

c)

d)

e)

o

g)h)

j)

thermometer taking into account, ifapplicable, the specified measuring ranges ofboth the interchangeable probes and theindicating unit;

Instructions and precautions for cleaning anddisinfecting the complete thermometer or theinterchangeable probes;

Identification of components and suitableinterchangeable parts such as probes andbatteries, including nominal voltage, ifapplicable;

Minimum time for achieving thermalequilibrium;

Description of transition from the predictedtemperature-measuring mode into the actualtemperature-measuring mode;

Instruction for the self-checking device;

Information on the correct environmentalconditions of use, storage, and transport ofthe thermomete~ and

Specific information should be provided bythe manufacturer, on request, regardingpossible sub-standard performance if usedunder the following conditions:

1) Outside the prescribed environmentaltemperature and humidity range, and

2) After an accidental mechanical shock.

5.2.3 For pattern evaluation the manufacturer shallprovide

a)

b)

c)

d)

e)

8

g)

h)

j)

k)

m)

n)

the following information:

Location of sensor from tip of probe;

Description and principles of measurementof complete thermometer;

Description of electrical principles and of anynecessary equipment provided;

Description of test for self-checking device;

Specified working range for battery;

Nominal and specified temperaturemeasuring ranges;

Nominal values of calibrations data for typeof temperature probe, as applicable;

Precautions for cleaning and disinfectingcomplete thermometer or temperature probes,as appropriate, including test results asspecified in Annex B;

Indication on instrument if a displayed valueis calculated;

Test results;

Results of clinical test of time responses(see 4.1.4 and Annex D); and

Operating manual and/or instructions(see 5.2.2),

6 TESTS

6.1 Thermometers shall be subjected to the followingtests.

NOTE — Requirements for the reference water-bath and the testfor maximum permissible errors are provided in Annex A. Theperformance requirements for the instrument and its majorcomponents are provided in 4.1 and 4.2. Where appropriate, anadditional description of required tests is provided in Annex B.

6.1.1 Probe

a)

b)

c)

d)

e)

f)

!3)

h)

Maximum permissible errors (see 4.1.2 andAnnex A),

Long-term thermal stability (see 4.2.1.2),

Electrical insulation and water resistance(see 4.2.1.3 and Annex B),

Location of sensor (see 4.2.1.4),

Mechanical strength (see 4.2.1.5),

Electrical contact resistance of connector(see 4.2.1.6),

Cleaning and disinfecting (see 4.2.1.7 andAnnex B), and

Stability with changes in temperature ofcables (see 4.2.1.8).

6.1.2 Indicating Unit

a)

b)

c)

d)

e)

0

Maximum permissible errors (see 4.1.2 andAnnex A),

Power provided to probe (see 4.2.2.1 andAnnex B),

Indication when connected to battery charger(see 4.2.2.2),

Indication if the thermometer is outside thespecified measuring range (see 4.2.2.4),

Self checking device (see 4.2.2.5), and

Display of predicting thermometer (see4.2.2.6j. -

6.1.3 Complete Thermometer

a)

b)

c)

d)

e)

o

g)

h)

j)

Maximum permissible errors (see 4.1.2 andAnnex A);

Low battery indication (see 4.2.3.1 andAnnex B);

Ambient temperature (see 4.2.3.2 andAnnex B);

Thermal shock (see 4.2.3.3 and Annex B);

Storage temperatures (see 4.2.3.4);

Humidity (see 4.2.3.5 and Annex B);

Electromagnetic radiation interference(see 4.2.3.6 and Annex B);

Mechanical shock (see 4.2.3.7 and Annex B);

Water resistance of small compactthermometers (see 4.2.3.8 and Annex C);

4

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A-

k)

m)

n)

Instructions and precautions for cleaning anddisinfecting the complete thermometer or theinterchangeable probes;

Identification of components and suitableinterchangeable parts such as probes andbatteries, including nominal voltage, ifapplicable; and

Minimum time for achieving thermalequilibrium by an indicating energydissipation requirements (see 4.2.1.1 andAnnex B).

A report of the results of tests required shall beprepared.

6.2 Verification

6.2.1 The laboratory shall examine the information

Is 15113:2002

provided by manufacturers as specified in 5.2.2.

6.2.2 The laboratory shall examine the instrument’spattern approval certificate mark(s) or label(s).

6.2.3 The laboratory shall carry out any of the testsindicated in 6.1 that maybe critical for the designatedapplication of the instrument.

NOTE — The tests indicated in Annex A maybe sufficient forverification.

6.2.4 The laboratory shall provide a verifiedinstrument with a mark or label.

6.2.5 The water resistance of small and compactcomplete thermometers shall be examined by meansof the procedure described in Annex C.

6.2.6 The laboratory shall indicate the period ofvalidity of the verification.

ANNEX A

(Clause 2.3)

ESTABLISHING REFERENCE TEMPERATURES ANDDETERMINING MAXIMUM PERMISSIBLE ERRORS

A-1 REFERENCE TEMPERATURES

A-1.l A well-regulated and stirred water-bathcontaining at least one litre in volume shall be usedto establish reference temperatures over themeasuring range for conducting various performancetests on an instrument. The bath shall be controlledto a temperature stability of better than* 0.02°C overthe specified temperature range and shall not have atemperature gradient greater than +0.0 1“C within itsworking space at a specified temperature. Thistemperature gradient shall be assured under allconditions and methods of loading temperatureprobes.

NOTE — The water-bath described above is referred to as a‘reference water-bath’ in this specification.

A-1.2 A reference thermometer with an expandeduncertainty no greater than 0.03°C (calculated for acoverage factor k = 3) shall be used to determine thetemperature of the water-bath. The calibration shallbe traceable to national measurement standards.

A-2 DETERMINING MAXIMUM PERMISSIBLEERRORS

A-2.1 Complete Thermometer

A-2.1.1 The temperature probe of a complete

thermometer shall be immersed in a reference water-bath at a constant temperature until temperatureequilibrium is established. The temperature indicatedby the thermometer shall be compared to that indicatedby the reference thermometer. The bath temperatureshall then be increased or decreased, the temperatureequilibrium re-established, and the measurementprocess repeated. The difference between the measuredand reference temperatures shall meet therequirements for maximum permissible errors asspecified in 4.1.2.

A-2.1.2 The number of measurements at differenttemperatures depends on the measuring range of theinstrument; however, measurements shall be carriedout for at least the following number of temperatureswithin the measuring range:

Measuring Range Number of Temperatures

<1 O“c 3

>1O”C 5

A-2.2 Interchangeable and Single-Use Probe

A-2.2.1 An interchangeable or single-use probe shallbe immersed in a reference water-bath as specified inAnnex A measured physical property of the probe shallbe converted to a temperature value by using an

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5

IS 15113:2002

appropriate instrument to measure a change in thatproperty as a function of temperature. For a resistance-type probe, an appropriate instrument for measuringits output signal may be an ohmmeter that can applypower to the probe at a level below the limit specifiedin 4.2.2.1 and the temperature value is obtained fromthe manufacturer’s data of resistance versustemperature. The expanded measurement uncertaintyof the appropriate instrument shall not be greater thana value equivalent to 0.01“C (calculated for a coveragefactor k = 3), referring to the manufacturer’s data at atemperature of 37°C, The calibration shall be traceableto national measurement standards. Each temperaturevalue obtained for the probe in this way shall becompared to that indicated by the referencethermometer in the bath. The difference between thesetemperature values shall meet the requirements formaximum permissible errors as specified in 4.1.2.

A-2.2.2 The number of measurements required shallbe the same as specified in A-2.1.2.

A-2.3 Indicating Unit

A-2.3.1 The performance of an indicating unit shall

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be tested using a device that simulates the relevantphysical properties of the appropriate probe type. The *

expanded measurement uncertainty of the simulating Jdevice shall not be greater than a value equivalent to0.0 1°C (calculated for a coverage factor k = 3),referring to the manufacturer’s data at a temperature R

,~t.

of 37”C. The calibration shall be traceable to national J

measurement standards.

NOTE — For example, a calibrated decade resistance box maybe used to provide a variable resistance to simulate a resistance-type probe. Values of resistance for input to the indicating unitover its specified measuring range shall be selected fromthe manufacturer’s data of resistance versus temperature. Simi-larly, variable voltage sources may be used to simulate a thermo-couple.

A-2.3.2 The difference between the temperaturesdisplayed by the indicating unit and the correspondingsimulated values of temperature shall meet therequirements for maximum permissible errorsspecified in 4;1.2.

A-2.3.3 The number of measurements shall be thesame as specified in A-2.1.2.

ANNEX B

(Clause 4.2.1.7)

BRIEF DESCRIPTION OF INSTRUMENT PERFORMANCE TESTS

B-1 ENERGY DISSIPATION OF A RESISTANCE-TYPE INTERCHANGEABLE PROBE

B-1.l The probe shall be placed in a reference water-bath as specified in A-1.l at a temperature of37 * l“C.Measurements shall be carried out at three or mored.c. currents with the highest power being 2 mW. Foreach applied current, the voltage and current shall bemeasured.

B-1.2 The equivalent resistance values shall becalculated and then converted to temperature valuesusing the manufacturer’s characteristic (resistanceversus temperature) table for the probe type. A linear(least-squares tit) curve of temperature as a functionof applied power shall be drawn. From this curve,power corresponding to the maximum energydissipation that will cause a change in indicatedtemperature by 0.01 “C for reusable, interchangeable,or single-use probes shall be determined. This valueis the maximum power that may be provided by anindicating unit for the type of probe tested and themanufacturer’s specified value shall be equal to or lessthan the value determined.

6

B-2 ELECTRICAL INSULATION RESISTANCEOF THE PROBE

B-2.1 The resistance of the temperature probe shallbe determined at one or more temperatures using theprocedure specified in Annex A. The probe shall thenbe immersed to a length equal to that intended to bein contact with the body, or, 50 mm, whichever isgreater, in a physiological saline solution (9.5 g ofNaCl per litre of distilled water).

B-2.2 After at least one minute, the resistance betweenthe electrical connections of the probe taken togetherand an electrode immersed in the physiological salinesolution shall be measured using an instrument thatapplies a voltage of 10 + 1 V between the probeconnections and the electrode. The resistancemeasured shall be greater than the shunt resistancethat would correspond to a change in indicatedtemperature of 0.02°C.

B-2.3 The probe shall be left in the physiological salinesolution for 24 h, after which its resistance shall beremeasured as specified in B-2.1 above. The difference

in indicated temperature between measurements shallnot be greater than 0.02”C.

B-3 CLEANING AND DISINFECTING THEPROBE

B-3.1 The applied part of the temperature probe or ofthe complete compact thermometer shall be cleanedand disinfected twenty times according to themanufacturer’s instructions.

B-3.2 After cleaning and disinfecting as specifiedin B-3.1, the requirements of 4.1.2 shall be met.

B-4 LOW BATTERY INDICATION

NOTE — From B-4 to B-9 of Annex B it is to be understood thatthe temperature indication of a complete thermometer shall begenerated within the measuring range by inserting the probe in areferencewater-bath or in another bath with similar qualities.Thetemperature indication of an indicating unit designed forusewithinterchangeableprobesshallbegeneratedbyreplacingtheprobebyanauxiliarydevice, such as an appropriate precision resistorsimulating the temperature of a resistance probe. The referencetemperature indication is that obtained under the referencecondi-tions described in 4.1,3.

B-4.1 The battery shall be replaced by a variable d.c.voltage source.

B-4.2 The voltage of the source shall be reduced untila low battery indication or warning signal is activatedat the level specified by the manufacturer. The testshall be carried out at three different temperatures; 37+ 1‘C, and the lower and upper limits of the measuringrange.

B-5 AMBIENT TEMPERATURE

B-5.1 The complete thermometer or indicating unitshall be placed in a test chamber, and the temperatureof the chamber varied from 10 to 40°C with eachtemperature setting constant within *2°C. Sufficienttime shall be allowed at each temperature setting topermit the complete the thermometer or indicating unitto reach thermal equilibrium with the chamber.

B-5.2 At each temperature tested, the requirementsspecified in 4.1.2 shall be met.

B-6 THERMAL SHOCK

B-6.1 The indicating unit shall be placed in a testchamber at – 5 * 2“C.

B-6.2 After thermal equilibrium has been established,the complete thermometer or indicating unit shall beplaced in a test chamber at 50 * 2°C until thermalequilibrium has been established and all traces ofcondensed moisture have evaporated.

B-6.3 The process described in B-6.1 and B-6.2 shallbe performed five times.

B-6.4 The indicating unit shall be allowed to achieve

.

IS 15113:2002

thermal equilibrium at room temperature after whichthe indicated temperature shall not change by morethan +0. 1‘C as a result of exposure to the thermalshocks described in B-6.1 and B-6.2.

NOTE — Thermal equilibrium maybe achieved more quicklyand completely by opening the casing of the thermometer, ifpossible.

B-7 HUMIDITY

B-7.1 The complete thermometer or indicating unitshall be stabilized at a temperature, t within the range20 to 32°C for 4 h or more. During this time, tshallremain constant within * 2“C.

B-7.2 After achieving a stable temperature as specifiedin B-7.1 the complete thermometer or indicating unitshall be placed in a humidity test chamber containingair at a temperature between t and t+ 4°C and a relativehumidity between 91 percent and 95 percent for aperiod of 48 h.

B-7.3 After exposure as specified in B-7.2, thecomplete thermometer or indicating unit shall beremoved from the test chambefand allowed to stabilizeat room temperature for 48 h. The indicatedtemperature shall not vary by more than* 0.1“C as aresult of this test.

B-8 ELECTROMAGNETIC RADIATIONINTERFERENCE

B-8.1 The complete thermometer or indicating unitshall be exposed to an electromagnetic field with afield strength of 10 V/m at frequencies between150 kHz and 500 MHz sine wave and 80 percentamplitude modulation.

B-8.2 The specific field strength shall be establishedprior to testing and without the instrument beingplaced in the electromagnetic field. The field strengthmay be generated as follows:

a) A strip line for low frequencies (below 3 MHzor in some cases 150 MHz) for smallinstruments; and

b) Dipole antennas, or antennas with circularpolarization, placed 1 m from the instrumentat higher frequencies.

B-8.3 The field shall be generated with two orthogonalpolarizations and then slowly scanned through thefrequency range. Antennas with circular polarizationmay be used to generate the electromagnetic fieldwithout a change in their positions. The test shall becarried out in a shielded enclosure to comply withinternational laws prohibiting interference with radiocommunications, but care shall be taken to minimizereflections.

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IS 15113:2002

B-8.4 During the test, the requirements specified shall be allowed to fall from a height of 1 m on to ain 4.2.3.6 shall be met. hard surface (for example, a block of hard wood of

NOTE — With reference to testing and test equipment, see IECdensity greater than 700 kg/m3 and of suitable size

Publication 61000-4-3(1995) ‘Electromagnetic compatibility lying flat on a rigid base). This drop shall be performed(EMC) Part 4: Testing and measurement techniques — Section once for three different orientations of the complete3: Radiatedradio-tlequency,electromagneticfield immunitytest.’ thermometer or indicating unit.

B-9 MECHANICAL SHOCK B-9.2 After the test, the requirements specified

B-9.1 The complete thermometer or indicating unitin 4.2.3.7 shall be met.

ANNEX C

(Clauses 6.1.3 and 6.2.5)

TEST OF WATER RESISTANCE OF COMPLETE THERMOMETERS

C-1 PATTERN APPROVAL

C-1.l A total of 10 samples shall be tested.

C-1.2 The battery casing shall be opened and closedseveral times before the tests if the thermometer isequipped with replaceable batteries.

C-1.3 The thermometer shall be totally immersed inan equivalent physiological solution (9.5g NaCl perlitre of distilled water) to a depth of 15 cm and attemperatures of 50”C and 20”C for the followingperiods of time and in the sequence indicated:

a) 1 hat 50 * 2“C,

b) 1 hat 20 + 2°C,

c) 24 h at 50 * 2“C, and

d) 24 hat 20 * 2“C.

C-1.4 The indicated values shall be measured at twoor more temperatures near the lower and upper limitof the measuring range before the first immersion andafter the second and last immersion. The thermometersshall have reached equilibrium with room temperaturebefore recording the indicated values. After the lastimmersion, the thermometers shall be stored for14 days in air at room temperature before taking thelast measurement.

C-1.5 The test may be discontinued if it is obviousthat water has penetrated into the casing of athermometer.

C-1.6 The thermometer pattern shall be declared tobe water resistant if, for nine out of ten thermometers,the difference in indicated temperatures for anyindividual thermometer is less than:

a) 0,04°C for thermometers with a minimumdigital increment of 0.01 ‘C (Class I), and

b) 0.1 “C for thermometers with a minimumdigital increment of O.l°C (Class II).

C-2 VERIFICATION

C-2.1 The thermometers shall be totally immersed inart equivalent physiological solution at a temperatureof 50 * 2°C to a depth of 15 cm for 1 h, after whichthey shall be immersed for another hour under sameconditions but at a temperature of 20 * 2“C. Beforethe first immersion and afier the second immersion,the indicated values shall be measured at twotemperatures.

C-2.2 A thermometer shall be accepted if theperformance requirements specified in C-1.6 are met,

/

1s 15113:2002

ANNEX D

(Ckwe401 .4)

CLINICAL TEST OF RESPONSE TIME

D-1 NON-PREDICTING CLINICAL

ELECTRICAL THERMOMETERS

The minimum time for achieving thermal equilibriumat each appropriate body site shall be determined onthe basis of testing at least ten persons.

D-2 PREDICTING (CALCULATING) CLINICALELECTRICAL THERMOMETERS

D-2.1 The difference between the displayed calculatedtemperature and the corresponding measuredtemperature at thermal equilibrium of a calculating(predicting) thermometer shall be determined on the

basis of testing at least 100 persons. The predictedtemperature of each person at an appropriate body siteshall be determined by the method specified by themanufacturer. After the predicted indication, thethermometer shall remain at the site for measuringand indicating the actual temperature of its sensor.The total time allowed shall be sufficient to attainthermal equilibrium. The difference in the first andsecond indicated temperatures for 95 percent of thepersons tested shall not be more than 0.2”C.

D-2.2 If an oral (sublingual) test has been carried out,the minimum number of persons required for rectalmeasurement shall be twenty.

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9

Bureau of Indian Standards

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This Indian Standard has been developed from Doc : No. MHD 12 (2814).

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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