STD. BSI SS: EN 12 1InJ.

-3ENtiL 2000

1624669

[]al~657 5

88T

BRfinSHSTANDARD

BSEN
12470-3:2000

Clinical
thermometers Part 3: Performance of compact electrical
thermometers (non-predictive and
predictive) with maximum device

The European Standard EN 12470-3:2000 has the status of a

British Standard

ICS 11.040.55

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMI'ITED BY COPYRIGHT LAW

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:10 2007

STD. BSI DS EN 121.J70-3-'EN6L 2001]

1624669 0846516 116

BS EN 12470-3:2000

National foreword
This British Standard is the official English language version of EN

1247~:2000.

The UK participation in its preparation was entrusted by Technical Conunittee

LBItJ6, Laboratory glassware and related apparatus, to Subconunittee LBItJ6tJ,
Thenuometers, which has the responsibility to:
-

aid enquirers to understand the text;

present to the responsible European conunittee any enquiries on the

interpretation, or proposals for change, and keep the UK interests infonued;

monitor related international and European developments and promulgate

them in the UK.

A list of organizations represented on this subconunittee can be obtained on request

to its secretary.

Cross-references
The British Standards which implement international or European publications
referred to in this document may be found in the BSI Standards Catalogue under the
section entitled "International Standards Correspondence Index", or by using the
"Find" facility of the BSI Standards Electronic Catalogue.
A British Standard does not purport to include all the necess&y provisions of a
contract Users of British Standards are responsible for their correct application.

Compliance with a British Standard does not of itself confer immunity

from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the EN title page,
pages 2 to 9 and a back cover.
The BSI copyright notice displayed in this document indicates when the document
was last issued.
This British Standard, having

been prepared under the

direction of the Sector
Committee for Materials and
Chemicals, was published under
the authority of the Standards
Committee and comes into effect
on 15 April 2000

Amendments issued since publication

AmdNo.

BSI 04-2000

ISBN 0 580 34605 6

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:45 2007

Date

Corrunents

STD. BSI

as

EN 12 l I7U":l-ENGL 20UO

lbt!'fbb9 08465."77 6!i2 _

EN 12470-3

EUROPEAN SfANDARD

NORME EURopEENNE
EUROPAIscHE NORM

Janwuy 2000

ICS 17.200.20

English version

Clinical thennometers Part 3: PeIfonnance of compact electrical thennometers

(non-predictive and predictive) with rnaxinll.Hn device

Thennometres medicaux Partie 3: Perfonnances des thennometres

electriques compacts (a comparaison et a
extrapolation) avec dispositif a maximum

Medizinische Thennometer Thil3: Elecktrische (extrapoJierende md nicht

extrapoJierende) Kompaktthennometer mit
Maximumvonichtung

This European Standard was approved by CEN on 13 May 1999.

CEN members are boWld to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a
national standard without any alteration Up-to-date lists and bibliographical

references concerning such national standards may be obtained on application to

the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German).
A version in any other language made by translation Wlder the responsibility of a
CEN member into its own language and notified to the Central Secretariat has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech
Republic, Denmark, Finland, France, Gennany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
United Kingdom.

CEN
European Committee for Standardization
Comite Europeen de Nonnalisation
Europaisches Komitee fur Normung

Central Secretariat: rue de Stassart 36, B-I050 Brussels

2000 CEN All rights of exploitation in any form and by any means reseIVed worldwide for CEN national
Members.
Ref. No. EN 1247~:2000 E

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:45 2007

STD.BSI BS EN

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l.b246b9 08lfb578 599 . ,

Page 2
EN 12470-3:2000

Foreword
This European Standard has been prepared by
Technical Committee CENII'C 205, Non-active medical
devices, the Secretariat of which is held by BSI.
This European Standard shall be given the status of a
national standard, either by publication of an identical
text or by endorsement, at the latest by July 2000, and
conflicting national standards shall be withdrawn at
the latest by July 2000.
This European Standard has been prepared under a
mandate given to CEN by the European Commission
and the European Free Trade Association, and
supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see infonnative
annex ZA, which is an integral part of this standard.
According to the CEN/CENELEC Internal Regulations,
the national standards organizations of the following
countries are bound to implement this European
Standard: Austria, Belgium, Czech RepubliC, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
This European Standard applies to clinical
thennometers which are used for measuring the body
temperature of humans.
EN 12470 consists of the following parts under the
general title "Clinical thennometers":

Contents
Page
Foreword

Scope

2.

Nonnative references

Definitions

Unit

'JYpes of thennometers

Performance requirements

7
8

Test methods
Information supplied by the
manufacturer
Annex A (infonnative) Suggested types of
testing for the requirements of this standard
Annex B (Wonnative) Bibliography
Annex ZA (infonnative) Clauses of this
European Standard addressing essential
requirements or other provisions of EU
Directives

2
3
3
3
3
3
3
5

7
8
8

- Part 1: Metallic liquid-i~glass thermmneters

with, mo:x:imum device;
- Part 2: Phase ch4nge-type (dot matrix)
themurmeters;

- Part 3: Performance of cmnpact elEctriool

themurmeters (non-predictive and predictive) with
maximum device;
- Part 4:1) Peiformance of elEctrical tJwrrrwmeters
for rontinuous measurements;
- Part 5: 1) Peiformance of irifra-red ror
thermometers (with, 1rULXimum device).
Annexes A. B and ZA are infonuative.

1)

In preparation.

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EN 12470-3:2000

1 Scope

3.2

This part of EN 12470 specifies the performance

requirements for compact clinical electrical
thennometers with maximum device (non-predictive
and predictive).
This European Standard applies to devices that, when
taking temperatures, are powered by an internal power
supply and that provide a digital indication of
temperature.
This European Standard does not apply to clinical
electrical thennometers for continuous measurement
and thermometers intended to measure skin
temperature.

compact predictive thermometer

device which calculates the maximum temperature of a
probe in contact with a body cavity, without waiting
for thermal equilibrium to occur, by heat transfer data
and a mathematical algorithm and maintains the
calculated maximum temperature value for a specified
time or until reset by its user

2 Nonnative references
This European Standard inCOlporates by dated or
undated reference, provisions from other publications.
These nonnative references are cited at the
appropriate places in the text and the publications are
listed hereafter. For dated references, subsequent
amendments to or revisions of any of these
publications apply to this European Standard only
when incorporated in it by amendment or revision. For
undated references the latest edition of the publication
referred to applies.
EN 980, Graphical symbols far use in the labelling of

medical devices.
EN 1041, Informatitm supplied by the manufacturer
with medical devices.
prEN 12470-1:1998, Clinical thermometersPart 1: Metallic liquid-in-glass thermometers with
maximum de/Jice.
EN 60601-1, Medical electrical equipmentPart 1: General requirements far safety.
EN 60601-1-2, Medical electrical equipmentPart 1: General requirements far safety - 2: Collateral
Standard - Electromagnetic compatibility Requirements and tests.
ISO 2859-2: 1985, Sampling procedures for inspectitm
by attributes - Part 2: Sampling plans indexed by
limiting quality (LQ) for isolated lot inspectitm.

3.3
compact non-predictive thermometer
device with a part or function of the thennometer that
monitors over a required period of time the
temperature measured by a temperature probe in
contact with a body cavity after which it indicates and
maintains the maximum temperature value for a
specified time or until reset by its user

3.4
indicating unit
component of the thermometer that processes the
output signal of the temperature sensor and displays
the value of the temperature

3.5
maximum device
part or function of the thermometer which stores and
indicates the numerical value of the maximum
temperature

3.6
temperature probe
component of the thennometer, part of which is
applied to a body cavity and establishes temperature.
It comprises a temperature sensor with associated
parts including coverings, seals, and inner leads when
necessary
NOTE A body cavity can be the mouth, rectum, armpit or
naso-pharynx.

4 Unit
The unit of temperature shall be the degree Celsius,
symbolC.

S Definitions

5 'JYpes of thennometers

For the purposes of this part of EN 12470 the

following definitions apply.

The types of compact clinical electrical thennometers

with maximum device shall be:
a) non-predictive thermometers;
b) predictive thermometers.

3.1
compact electrical thermometer
contact thermometer that consists of a temperature
probe and an indicating unit pennanently connected
together

BSI 04-2000

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6 Performance requirements
6.1 Probe cover
If protective probe covers are recommended or
supplied by the manufacturer, the thennometer
together with the probe cover shall meet the
requirements specified in this standard

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EN

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2000

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EN 12470-3:2000

6.2 Metrological requirements

6.2.1 Measuring range
The thermometer shall cover the minimum measuring
range from 35,5C to 42,0 DC.
The thermometer shall provide a visual or auditoty
warning when the measured value of temperature is
not within its specified measuring range.
Testing shall be canied out in accordance with 7.2.

6.2.2 Digital increment

The digital increment of the indicating unit shall be
0,1C or less.
Testing shall be performed by visual inspection

6.2.3 Maximum permissible error under reference

conditions
The maximum permissible error for the measuring
range 35,5 OC to 42,0 C shall be 0,1 C within the
ambient temperature range from 18C to 28 QC. Outside
the measuring range of 35,5 C to 42,0C or outside the
ambient temperature range, the maximum permissible
error shall not be greater than twice the specified
value.
Testing shall be in accordance with 7.3.
For predictive and non-predictive thermometers with
an offset, the manufacturer shall provide information
on:
a) data. obtained from the result of a clinical
investigation;
NOTE For this investigation predictive thermometers can be
modified by incorporating a switch to allow operation
alternatively in predictive and non-predictive mode.
In the non-predictive mode the thermometer should meet the
requirements of 6.2.3 when tested according to 7.2. In this case
the thermometer is tested in the predictive mode and read, then
the mode is switched to non-predictive and the temperature is
read again after achieving thermal equilibrium. The two
temperature readings should not differ by more than 0,2 C for
more than 98 % of the subjects.
In the case that the thermometer to be investigated cannot be
modified accordingly, it should be compared against a
calibrated clinical reference thermometer, preferably at the
same body site.
Selection of test persons should be in accordance with the
intended use of the thermometer.
The clinical test should be performed in accordance with
Annex X of the Medical Device Directive (MOD).

b) the procedure for testing in a water bath.

6.2.4 71me response

When a non-predictive thermometer at a temperature
of (23 2) C is immersed into a water bath at
(37 1) C for 60 s the indicated temperature shall not
differ from the reference temperature by more than the
maximum pennissible error.
Testing shall be performed in accordance with 7.4.

6.2.6 Maximum errergy dissipation

The indicating unit shall provide an energizing
potential sufficiently low so that the energy dissipation
(j2.R) in the probe shall not cause an increase in
indicated temperature by more than 0,01 C when the
probe is immersed in a reference water bath at
(37 0,1) QC.
Testing shall be performed in accordance with 7.5.

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6.2.6 Long term stability

The long term stability of the thermometer, after
exposing it for a minimum of 288 h to a temperature of
(55 2) QC, or for a minimum of 96 h to a temperature
of (SO 2) cC, shall be such that the values for
maximum pennissible errors specified in 6.2.3 are met
Testing shall be performed in accordance with 7.6.
6.3 Environmental requirements

6.3.1 Ambient operating range

The minimum ambient operating range of the
thermometer shall be from + 10 C to +35 qc.
When tested in accordance with 7.7, the thermometer
shall comply with 6.2.3.

6.3.2 ~ect of storaqe

When tested in accordance with 7.8, the thermometer
shall comply with 6.2.3.

6.3.3 Thermal shock

When tested in accordance with 7.9, the thermometer
shall comply with 6.2.3.
.

6.3.4 Humidity
When tested in accordance with 7.10, the thermometer
shall comply with 6.2.3.

6.3.5 Electromagrretic compatibiUty

The thermometer shall comply with EN 60601-1-2.

6.3.6 Mechanical shock

When tested in accordance with 7.11, thermometers
with a housing of plastic or metal shall comply
with 6.2.3.

6.3.7 Water resistance

When tested in accordance with 7.12, the thermometer
shall comply with 6.2.3.
6.4 Construction requirements

6.4.1 Functional rmits

6.4.1.1 Voltage limit indication
The thermometer shall automatically provide a visual
or auditory warning when its supply voltage is not
within specified limits and shall meet the maximum
permissible errors in 6.2.3 when the voltage is within
these specified limits.
Testing shall be performed in accordance with 7.13.

6.4.1.2 Indicating unit

Numerical values on the display, shall be at least 4 mm
high or optically magnified so as to appear that height
After power-on all segments shall be activated for at

least 1 s.
Testing shall be performed by visual inspection.

6.4.1.3 Functional safe test

The thermometer shall have a self-testing routine. The
correct operation shall be indicated by a given display.
The manufacturer shall provide information as to how
the self-testing routine operates and what display is to
be expected.

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EN 12470-3:2000

6.4.2 Malerial
The thennometer shall be free from biological hazards.
NOTE See EN ISO 10993-1 for the selection of appropriate test
methods.

6.5 Electrical safety

The thennometer shall comply with EN 60601-1.
6.6 Mechanical safety

7.2.2 Procedure
Inunerse the temperature probe of a compact
thermometer to a depth according to the
manufacturer's specification in a reference water
bath (7.2.1.2) at constant temperatures 0,3C below
the minimum and maximum values and 0,3 C above
the minimum and maximum values of the measuring
range specified by the manufacturer. The thennometer
passes the test if the requirements of 6.2.1 are met

6.6.1 Themwmeter

7.2_3 Expression of results

Thennometers shall not have shalp ends or angles that

could iI\jure the user or patient
The temperature probe shall be smoothly rounded in
order to prevent tissue damage during use.
Testing shall be perfonned by visual and tactile
inspection.

Report if temperatures are displayed or warnings are

given.
7.3 Method of test for compliance with the

6.6.2 Resistance to breakage

A thennometer with a housing of glass shall comply
with 6.1.2.7 of prEN 12470-1:1998.

7 Thst methods
7.1 General
7.1.1 Each individual lot shall be subjected to testing,
either individual or statistical.
For statistical testing, the lot shall be homogenous and
thennometers from various sources shall not be mixed
The sampling plan shall correspond to ISO 2859-2: 1985,
Level n with limiting quality level LQ =5 %.
NOTE 1 Other sampling plans can be used if they are
statistically equivalent.
NOTE 2 For suggested types of testing see annex A.

7.2 Method for the determination of the

measuring range

7.2.1 Apparatus
7.2.1.1 Rliference thermometer, with an uncertainty in
temperature reading not greater than O,02 C
(coverage factor k =2), shall be used to detennine the
temperature of the water bath. Its calibration shall be
traceable to national measurement standards
NOTE The definition of the coverage factor Ok" is found in the
"Guide to the expression of uncertainty in measurement".

7.2.1.2 Reference water bath, well regulated and

stirred and containing at least 5 I in volume shall be
used to establish reference temperatures over the
measuring range. It shall be controlled to have a
temperature stability of better than O,02 C over the
specified measuring range of temperature of the
thennometer to be tested. It shall have a temperature
gradient of not greater than O,O! C within its working
space at a specified temperature.
This temperature gradient shall be assured under all
conditions and patterns of loading of thennomet.er
samples.

BSI 04-2000

Copyright by the European Committee For Standardization

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maximum permissible error under reference

conditions
7.3.1 Apparatus
Use the apparatus described in 7.2.1.
7.3.2 Rfd"erence conditions
The reference conditions for the requirements shall be
an ambient temperature of (23 5) C and a relative
humidity of (50 20) % RH with the instrument
operating within the specified range of the supply
voltage.

7.3.3 Procedure
7.3.3.1 Inunerse the temperature probe of a compact
thermometer in the reference water bath until the
thermometer has reached thermal equilibrium with the
water bath or for the time period specified by the
manufacturer.
7.3.3.2 Compare the temperature indication of the
thennometer to the indication of the reference
thennometer (7.2.1.1). The difference between the
measured and reference temperatures shall meet the
requirements specified in 6.2.3.
7.3.3.3 The number of measurements at different
temperatures required depends upon the measuring
range of the instrument; however, measurements shall
be perfonned at least at every full degree Celsius of
the measuring range to detennine potential
inhomogeneities or resonances that can cause the
exceeding of the maximum permissible error in
small sub-ranges. This test shall be perfonned on at
least 10 thennometers. Once it is verified that no
inhomogeneities or resonances in small sub-ranges
exist, the test shall be continued at a reduced number
of temperature points (recommended three points)
spaced approximately equally throughout the
measuring range.

7.3.4 Expression of results

For non-predictive thennometers calculate the error of
the thennometer from the following expression:
e=lj-fwb

where
~

is the temperature indicated at the thennometer

to be tested;
fwb is the temperature of the water bath determined
with the reference thennometer.

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EN 12470-3:2000

For predictive thennometers or thennometers with an

offset, calcuJate the error from the following
expression:
e=lj-tc-twb
where

tc

is the difference in C specified by the

manufacturer for testing in a water bath after a
specified inunersion time.

7.4 Method of test for the determination of time

response
7.4.1.Apparalus
Use the apparatlE described in 7.2.l.
7.4.2 Procedure
7.4.2.1 Immerse the temperature probe of a compact
thennometer at a temperature of (23 2) C to a depth
specified by the manufacturer in a water bath at a
constant temperature of (37 1) C for 60 s and
withdraw the thennometer.

7.4.2.2 Compare the temperature indication of the

thennometer to the indication of the reference
thennometer (7.2.1.1). The difference between the
measured and reference temperatures shall meet the
requirements specified in 6.2.4.

7.5 Method of test for the determination of the

maximum energy dissipation
7.5.1.Apparatus
7.5.1.1 &iference water bath, in accordance
with 7.2.1.2.
7.5.1.2 Constant current power supply.
7.5.1.3 Calibrated voltmeter.
7.5.1.4 Calibrated ammeter.
7.5.2 Procedure
7.5.2.1 Disconnect the electrtcal leads of the
temperature probe from the indicating unit Connect
them to the constant power suppJy and the measuring
instruments. Immerse the thennometer in the reference
water bath in accordance with the manufacturer's
specification at a temperature of (37 1) QC.

7.5.2.2 Apply a constant current to the temperature

probe. Measure the applied current and voltage.
Perfonn the measurements at three or more currents.
The maximum power shall be 2 mW.
7.5.2.3 Expression of results
Calcu1ate the equivalent resistance values and then
convert them to temperature values using the
manufacturer's characteristic (resistance vs.
temperature) table for the probe type. Draw a linear
(least squares fit) CUIVe of temperature as a function of
applied power. From this curve, detennine the power
corresponding to the maximum energy dissipation that
will cause a change in indicated temperature by
0,01 cC. 1bis value is the maximum power that can be
provided by an indicating unit for the probe type and
the manufacturer's specified value shall be equal to or
less than the value detennined

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7.6 Method of test for the determination of the

long term stability

7.6.1.Apparatus
Temperature chamber, capable of producing
temperatures necessary for testing.

7.6.2 Procedure
Place the thennometer into the temperature chamber
for 288 h at a temperature of (55 2) C or for 96 h at
a temperature of (80 2) QC.

Test according to 7.3 at three different temperatures

spaced approximateJy equally over the measuring
range.
7.7 Method of test for the determination of the
minimum ambient operating range
Testing shall be perfonned in accordance with 7.3 but
at an ambient temperature of (11 1) C and (34 1) C
and with a water bath temperature of (37 1) CC.
7.8 Method of test for the determination of the
effect of storage

7.8.1.Apparalus
Use the apparatus described in 7.6.1.

7.8.2 Procedure
Store the thennometer in its unopened primary
package for the following test cycle sequence:
a) (24 1) h at -(25 2) QC;
b) (24 l)h at +(252) cC;
c) (24 1) hat +(55 2) QC;
d) (24 l)h at +(252)OC;
e) (24 1) h at +(25 2) QC.
Remove the samples with their packaging unit intact
from the temperature chamber (7.6.1) and allow them
to remain at ambient temperature for at least 24 h.
Then remove the thennometers from their packaging
and complete the test in accordance with 7.3 at three
different temperatures spaced approximateJy equalJy
over the measuring range.

7.9 Method of test for thermal shock

7.9.1.Apparatus
7.9.1.1 7Wo temperature chambers, capable of
producing temperatures necessary for testing.

7.9.2 Procedure
Place the thennometer in the temperature
chamber (7.9.1) for the following test cycles:
a) 1 h at a temperature of (0 2) QC;
b) 1 h at a temperature of (55 2) QC.
Perform these test cycles five times.
The test samples shall be moved within 30 s from one
to the other temperature chamber.
Then the thennometer shall be allowed to achieve
thennal equilibrium at room temperature after which
the requirements of 6.2.3 at a test temperature of
(37 1) C shall be met

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7.10 Method of testing for the effect of

humidity

7.10.1 Apparatus

8 Infonnation supplied by the

manufacturer

hwnidity.

8.1 General
Information supplied by the manufacturer shall comply
with the specification given in EN 1041. If symbols are
used, they shall be in accordance with EN 980.

7.10.2 Procedure

8.2 Marking

Place the thennometer into the climatic

chamber (7.10.1) at a temperature of (45 2) C and a
relative humidity of (85 5) % RH for 48 h.
Remove the thermometer from the climatic chamber
and allow it to achieve thennal equilibrium at room
temperature. Testing shall be performed in accordance
with 7.3 at three different temperatures spaced
approximately equally over the measuring range.

In addition to 8.1 the thermometer shall be marked

with at least the following infonnation:
a) the symbol "OC" adjacent to the numerical value, if
not indicated at the display;
b) body site (e.g. mouth, rectum), if restrictions
apply;

7.10.1.1 Climatic chamber, capable of producing an

environment of (45 2) C and (85 5) % relative

7.11 Method of test for mechanical shock

7.11.1 Apparatus
A block of hard wood of density greater than
700 kWm3 and of suitable size lying flat on a rigid base.
7.11.2 Procedure
The thermometer shall be permitted to fall freely
through a vertical distance of 1 m onto the hard
surface (7.11.1). This drop shall be performed once
for each of three physical orientations of the complete
thermometer.
Subsequent testing shall be performed in accordance
with 7.3 at a temperature of (37 1) cc.

7.12 Method of test for water resistance

hrunerse the thermometer without any additional
covering completely in water in its service position as
specified by the manufacturer so that the following
conditions are satisfied:
a) the highest point of the thermometer is located at
least 15 cm below the surface of the water;
b) the duration of the test is (30 1) min.
Subsequent testing shall be performed in accordance
with 7.3 at a temperature of (37 1) cc.
7.13 Method of test for the voltage limit

7.13.1 Apparatus
Direct current voltage supply.

7.13.2 Procedure
Replace the internal power supply by a variable
de. voltage supply (7.13.1).
Acijust the voltage of the supply until a low battery
indication or warning signal is activated at a level
specified by the manufacturer. Test in accordance
with 7.3 at the lower and upper ends of the
temperature measuring range at ambient temperature.
If the thermometer has no replaceable power supply, it
is necessary to modify the thermometer to be
connected to an external power supply.

BSI 04-2000

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:47 2007

NOTE This can apply to predictive thennometers.

c) warning "not water-resistant" or an equivalent

statement, if the thermometer is not in conformance
with 6.3.7.

8.3 Instructions for use

In addition to 8.1 the thermometer shall be
accompanied by instructions for use containing at least
the following information:
a) information about the proper environmental
conditions of use, storage and transport;
b) disposal of the thermometer and its batteries;
c) reference to this European Standard and the
relevant part, including the complete title;
d) instructions for proper cleaning and disinfection;
e) measuring range and maximum permissible error
under reference conditions;
t) instructions for the functional safe test;
g) instructions for selection and replacement of
battery, if applicable;
h) probe cover usage, if applicable;
i) body site Ce.g. mouth, rectum);
j) recommended minimum measuring time at the
specific body site;
k) recommended maintenance and calibration
procedure, including frequency of recalibration;
1) information on whether the thermometer is a
predictive type and, if an offset is used, the
specification of the offset

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EN 12470-3:2000

Annex A (informative)
Suggested types of testing for the
requirements of this standard
In order to comply with the requirements of the
EU declaration of confonnity thermometers have to
comply with the requirements of either:
a) annex IT; or
b) annex VII coupled with annex IV or annex Vor
annex VI of the EU Directive for Medical Devices
931421EEC of 14 June 1993.
Annex A infonns and recommends on the volume of
testing suggested to comply with the requirements of
the Medical Device Directive.
The tests described in this standard should be
performed as follows.
1) Type A:. Tests that should be performed like type
examination tests. After initial verification of the
corresponding requirements these tests are to be
repeated as frequently as required to guarantee a
uniform production or product. The tests are to be
repeated whenever a relevant design or component
change is performed
These tests are appropriate where compliance with
the requirements of the standard can be
demonstrated by investigating a small number
(typically 10) of samples of the product.
2) Type B: Tests that show each lot of product
complies with the requirements of the standard
Tests according to Table A 1 should be performed on
each sample or according to a statistical sampling plan
that complies with the requirements of chapter 6 of
annex IV of the EU Directive for Medical Devices

93142/EEC.
Table A.l -

Suggested tests

Clauses on the requirements and test

methods

Lot by lot
testing, 1YPe B

6.2.117.2

Suggested tests (cantinued)

Lot by lot
testing, 1YPe B

6.2.617.6
(Long term stability)

6.3.117.7
(Ambient operating range)
6.3.2n.8
(Effect of storage)

6.S.3n.9
(Thermal shock)

6.S.5IEN 60601-1-2
(EMC)

6.3.M.ll
(Mechanical shock)
6.3.7n.12
(Water resistance)

6.4.1.117.13
(Voltage limit indication)

6.4.1.2IVJSual inspection
(Indicating unit)

6.4.1.S/VJSUal inspection
(Functional safe test)
6.4.2IEN ISO 10993-1
(Material)

6.51EN 60601-1
(Electrical safety)

6.6.INISUal. and tactile inspection

(Mechanical safety)
6.6.216.1.2.7 of prEN 12470-1:1998
(Resistance to breakage)
8.2IVJSUal inspection
(Marking)

X
X
X

8.3/VJSual inspection
(Instructions for use)

NOTE 'JYpe A testing is compulsory for all

clauses.

(Measuring range)
6.2.2IVJSUal inspection
(Digital increment)

6.2.M.S
(Maximum pennissible error)

Table A.l -

Clauses on the requirements and test

methods

6.2.417.4
(TIme response)
6.2.5n.5
(Maximum energy dissipation)

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:47 2007

Annex B (informative)
Bibliography
EN ISO 10993-1, Biological evol:uatian of medical
deuices - Part 1: Evaluation and testing
(ISO 10993-1:1997).
GUM 1993, Guide to the expression of uncertainty in

measurement.

BSI 04-2000

STD.BSI BS EN 12470-3-ENGL 2000 . .

162466~

0846585

72~

..

Page 9
EN 12470-3:2000

Annex ZA (infonnative)
Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European Conunission and the
European Free 'frade Association and supports essential requirements of EU Directive for Medical Devices

931421EEC.

WARNING. Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
The following clauses of this standard are likely to support requirements of Directives 931421EEC.
Compliance with this standard provides one means of conforming with the specific essential requirements of the
Directive concerned and associated EFfA regulations.
Table ZA.1- Correspondence between this European Standard and EU Directives
Clause/subclause of this European
Standard

Corresponding Essential Requirement

of Directive 931421EEC

10.3

1,2,3,4,5

6.2

10.1

6.2.6

9.2

6.3

9.2,10.1

6.3.5

9.2

6.3.7

7.6

6.4.1.1

10.1,12.2

6.4.1.2

10.2

6.5

9.2

6.6.1

9.2,12.7.1

6.6.2

9.2

1, 2, S,4, 5

7.2, 7.S, 7.4, 7.5

7.1

7.6, 7.7, 7.8, 7.9, 7.10, 7.11

9.2, 10.1

7.12

7.6, 9.2, 10.1

7.13

9.2, 10.1, 12.2

8.1,8.2

12.9,13.1

8.2a)

10.3

8.2b)

13.3i), lS.3j)

8.2c)

13.3k)

8.3

13.1, lS.6a), 13.6b)

8.3b)

lS.3n)

8.3d)

8.1,13.6h)

8.3e)

lS.6p)

8.Sf)

lS.6d)

BSI 04-2000

Copyright by the European Committee For Standardization

Tue Mar 13 15:00:47 2007

Comments

STD.BSI BS EN 1247D-3-ENGL 2DDD . . 1624669 D846586 665 . .

BSEN
12470-3:2000

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