Traceability and Use of Thermometers in Ukas Accredited Laboratories

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NATIONAL STANDARD METHOD

GUIDANCE NOTE

TRACEABILITY AND USE OF


THERMOMETERS IN UKAS
ACCREDITED LABORATORIES

QSOP 10

Issued by Standards Unit, Evaluations and Standards Laboratory


Centre for Infections

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 1 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
STATUS OF NATIONAL STANDARD METHODS
National Standard Methods, which include standard operating procedures (SOPs), algorithms and
guidance notes, promote high quality practices and help to assure the comparability of diagnostic
information obtained in different laboratories. This in turn facilitates standardisation of surveillance
underpinned by research, development and audit and promotes public health and patient confidence
in their healthcare services. The methods are well referenced and represent a good minimum
standard for clinical and public health microbiology. However, in using National Standard Methods,
laboratories should take account of local requirements and may need to undertake additional
investigations. The methods also provide a reference point for method development.

National Standard Methods are developed, reviewed and updated through an open and wide
consultation process where the views of all participants are considered and the resulting documents
reflect the majority agreement of contributors.

Representatives of several professional organisations, including those whose logos appear on the
front cover, are members of the working groups which develop National Standard Methods. Inclusion
of an organisation’s logo on the front cover implies support for the objectives and process of preparing
standard methods. The representatives participate in the development of the National Standard
Methods but their views are not necessarily those of the entire organisation of which they are a
member. The current list of participating organisations can be obtained by emailing
[email protected].

The performance of standard methods depends on the quality of reagents, equipment, commercial
and in-house test procedures. Laboratories should ensure that these have been validated and shown
to be fit for purpose. Internal and external quality assurance procedures should also be in place.

Whereas every care has been taken in the preparation of this publication, the Health Protection
Agency or any supporting organisation cannot be responsible for the accuracy of any statement or
representation made or the consequences arising from the use of or alteration to any information
contained in it. These procedures are intended solely as a general resource for practising
professionals in the field, operating in the UK, and specialist advice should be obtained where
necessary. If you make any changes to this publication, it must be made clear where changes have
been made to the original document. The Health Protection Agency (HPA) should at all times be
acknowledged.

The HPA is an independent organisation dedicated to protecting people’s health. It brings together
the expertise formerly in a number of official organisations. More information about the HPA can be
found at www.hpa.org.uk.

The HPA aims to be a fully Caldicott compliant organisation. It seeks to take every possible
precaution to prevent unauthorised disclosure of patient details and to ensure that patient-related
records are kept under secure conditions1.

More details can be found on the website at www.evaluations-standards.org.uk. Contributions to the


development of the documents can be made by contacting [email protected].

Please note the references are now formatted using Reference Manager software. If you alter or delete text
without Reference Manager installed on your computer, the references will not be updated automatically.

Suggested citation for this document:


Health Protection Agency (2007). Traceability and use of thermometers in UKAS accredited
laboratories. National Standard Method QSOP 10 Issue 4 http://www.hpa-
standardmethods.org.uk/pdf_sops.asp.

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 2 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
INDEX
STATUS OF NATIONAL STANDARD METHODS ................................................................................ 2

INDEX...................................................................................................................................................... 3

AMENDMENT PROCEDURE ................................................................................................................. 4

1 INTRODUCTION ............................................................................................................................ 5

2 CALIBRATION 130 ........................................................................................................................ 5

3 REFERENCE THERMOMETERS.................................................................................................. 5

4 WORKING THERMOMETERS ...................................................................................................... 6

5 CALCULATION OF THE UNCERTAINTY OF MEASUREMENT FOR WORKING


THERMOMETERS ......................................................................................................................... 6

6 RESOLUTION OF READING (LIQUID-IN-GLASS THERMOMETERS ONLY) ........................... 7

7 PARALLAX (LIQUID-IN-GLASS THERMOMETERS ONLY) ....................................................... 7

8 IMMERSION (LIQUID-IN-GLASS THERMOMETERS ONLY) ...................................................... 7

9 ACKNOWLEDGEMENTS AND CONTACTS ................................................................................ 8

APPENDIX 1 ........................................................................................................................................... 9

APPENDIX 2 ......................................................................................................................................... 10

APPENDIX 3 ......................................................................................................................................... 12

APPENDIX 4 ......................................................................................................................................... 14

APPENDIX 5 ......................................................................................................................................... 14

APPENDIX 5 ......................................................................................................................................... 15

APPENDIX 6 ......................................................................................................................................... 16

REFERENCES ...................................................................................................................................... 17

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 3 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
AMENDMENT PROCEDURE
Controlled document QSOP 10
reference
Controlled document title Traceability and use of thermometers in UKAS accredited
laboratories

Each National Standard Method has an individual record of amendments. The current amendments
are listed on this page. The amendment history is available from [email protected].

On issue of revised or new pages each controlled document should be updated by the copyholder in
the laboratory.

Amendment Issue no. Insert Page Section(s) involved Amendment


Number/ Discarded Issue
Date no.
5/ 3.2 4 All Title Liquid-glass removed
14.08.07 from title

8 Acknowledgements Revised and expanded


and Contacts

17 References References updated and


transferred to Reference
Manager software

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 4 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
TRACEABILITY AND USE OF
THERMOMETERS IN UKAS ACCREDITED
LABORATORIES

1 INTRODUCTION
This Guidance Note explains the UKAS requirements2-5 for the traceability of liquid-in-glass
thermometers. Traceability in this context is defined as the ability to relate a measurement to
the appropriate International Practical Temperature Scale (IPTS) through an unbroken chain
of comparisons.

Some information on reading thermometers is given and errors which may arise are
described. An example of the calculation of the uncertainty of measurement for working
liquid-in-glass thermometers is illustrated.

2 CALIBRATION 130
Calibration of reference thermometers should be carried out every five years by a UKAS
accredited calibration laboratory. A valid calibration certificate should be held for the
reference thermometer.

The calibration certificate should be current and bear the UKAS logo or the identity of the
national standards laboratory or logo of an accreditation body recognised by UKAS.

The certificate should also provide the required uncertainty of measurement suitable for the
procedure that the reference thermometer is being used for.

In-house calibrations and checks should be carried out according to a documented procedure.
The results and the estimate for the uncertainty of measurement should be recorded and
retained.
NOTE: a thermometer should be calibrated at either a minimum of five evenly spaced
temperatures or at intervals of 100 smallest scale divisions, covering 80% of the scale range.

3 REFERENCE THERMOMETERS
These should be of BS 593 specification and have a valid calibration certificate.

Re-calibration should be carried out at least once every 5 years. Some laboratories replace
these instead or re-calibrating them due to the time and cost implications.

A check should be carried out at least once a year against the ice point or, exceptionally,
some other appropriate reference point. This may be carried out in-house or by a UKAS
accredited calibration laboratory. An example of a procedure for checking against the ice
point is given in Appendix 1.

Reference thermometers should be kept secure in a suitable environment separate from


working thermometers.

As a minimum it is recommended that laboratories hold one reference thermometer of the


range 0°C to 60°C with 0.2°C divisions and one of the range 40°C to 70°C with 0.1°C
divisions.

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 5 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
4 WORKING THERMOMETERS
Where the accuracy of temperature measurement has a significant bearing on the test result
and is required to be controlled better than ± 0.1°C laboratories may use a working
thermometer with a valid UKAS or NPL certificate or calibrate the working thermometer in-
house against a reference thermometer held by the laboratory4. Such a working thermometer
should be of the appropriate range for the temperature measurements it is intended to control.

A check should be carried out at least once a year against the ice point or, exceptionally,
some other appropriate reference point such as the temperature that the thermometer is being
used to monitor (eg 37°C). In the latter case, where the working thermometer is held in liquid
(eg in a waterbath) the reference thermometer should also be placed in the liquid. When
calibrating against reference points the reference thermometer and the working thermometer
should be placed in close proximity to optimise the accuracy of calibration.

NOTE: if a thermometer is used to monitor a particular temperature (eg 37°C) the calibration
check should be made within five smallest scale divisions of that temperature.

Re-calibration should be carried out after 5 years or sooner if the annual checks at the
reference point reveal a significant change (eg > 0.1°C) has occurred.

NOTE: a change of about 0.04°C in the first year may be due to normal changes in the bulb
volume. This correction factor should be taken account of when making temperature
measurements with the thermometer4.

For new working thermometers reference point checks should be carried out at intervals not
exceeding 6 months in the first year.

Where the accuracy of temperature measurement does not have a significant bearing on the
test result (ie when temperature control does not need to be better than ± 0.1°C) laboratories
may use a BS 593 thermometer.

5 CALCULATION OF THE UNCERTAINTY OF


MEASUREMENT FOR WORKING THERMOMETERS
Tolerances should be set and should take into account the uncertainty of measurement for
critical temperature monitoring. This can be calculated in a number of ways depending on
whether or not a reference thermometer is used directly in the waterbath or incubator in
question. Illustrative examples are given in the tables below.

Table 1: When a calibrated reference thermometer is used directly in a waterbath or incubator

Reference thermometer uncertainty of measurement (expanded ± 0.05°C


uncertainty – see Appendix 2)
Test tolerance 44°C ± 0.25°C

Acceptable range for test 43.75°C to 44.25°C

New working tolerance for test 44°C ± (0.25 – 0.05)

= 44°C ± 0.2°C

New acceptable range for test 43.8°C to 44.2°C

NOTE: this calculation may be performed using the Excel programme “uofm3.xls.”
www.hpa-standardmethods.org.uk/documents/qsop/pdf/uofm3.xls

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 6 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
Table 2: When a thermometer that is not a calibrated reference thermometer is used in a
waterbath or incubator

Working thermometer uncertainty of measurement(expanded ± 0.12°C


uncertainty - see Appendix 3)
Test tolerance 44°C ± 0.25°C

Acceptable range for test 43.75°C to 44.25°C

New working tolerance for test (see Appendix 4) 44°C ± (0.25 – 0.12)

= 44°C ± 0.13°C

≅ 44°C ± 0.1°C

New acceptable range for test 43.9°C to 44.1°C

NOTE: this calculation may be performed using the Excel programme


www.hpa-standardmethods.org.uk/documents/qsop/pdf/uofm3.xls

Further information on calculating uncertainty of measurement may be found in M30035.

6 RESOLUTION OF READING (LIQUID-IN-GLASS


THERMOMETERS ONLY)
When reading a thermometer an uncertainty needs to be taken account of when the meniscus
falls between two intervals on the scale (see Appendix 5).

If the meniscus falls between two intervals and is above the target temperature the reading
should be made up to the nearest interval.

If the meniscus falls between two intervals and is below the target temperature the reading
should be made DOWN to the nearest interval.

NOTE: most thermometers are used vertically unless otherwise specified. If a thermometer is
held horizontally instead of vertically the internal pressure increases which results in a higher
reading.

7 PARALLAX (LIQUID-IN-GLASS THERMOMETERS


ONLY)
Errors due to parallax arise if the meniscus is not viewed with the eye normal to the stem (see
Appendix 6). The size of the error depends on the angle between the normal and the
incorrect line of sight, separation of the capillary and the graduation lines.

If necessary, errors may be reduced by using an optical aid, such as a lens held almost in
contact with the thermometer.

8 IMMERSION (LIQUID-IN-GLASS THERMOMETERS


ONLY)
The condition of immersion (usually engraved on the stem) should be observed. There are
three forms of immersion – total, partial and complete.
TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES
Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 7 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
Total immersion – the bulb and the liquid column are immersed so that only 1mm of the
column protrudes to enable temperature readings to be made. This form of immersion gives
the most accurate temperature readings.

Partial immersion – the thermometer is immersed to a specified depth (usually engraved on


the stem). This form of immersion produces uncertainties in temperature readings usually
twice that of total immersion.

Complete immersion – the entire body of the thermometer is immersed which causes the
internal gas pressure to be affected by the temperature of the medium.

9 ACKNOWLEDGEMENTS AND CONTACTS


This National Standard Method has been developed, reviewed and revised by the National
Standard Methods Working Group (http://www.hpa-
standardmethods.org.uk/working_groups.asp). The contributions of many individuals in
clinical bacteriology laboratories and specialist organisations who have provided information
and comment during the development of this document, and final editing by the Medical Editor
are acknowledged.

The National Standard Methods are issued by Standards Unit, Evaluations and Standards
Laboratory, Centre for Infections, Health Protection Agency London.

For further information please contact us at:

Standards Unit
Evaluations and Standards Laboratory
Centre for Infections
Health Protection Agency
Colindale
London
NW9 5EQ
E-mail: [email protected]

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 8 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 1: ICE POINT CHECK
1 Fill a container with finely crushed ice.
2 Add sufficient distilled or deionised water to produce a dense slurry.
3 Mix the ice and water carefully using a suitable stirrer to obtain a consolidated ice-water
mixture. The surface of the mixture should take on a grey rather than white appearance.
There should be sufficient water present so that manual compression of the ice at the surface
causes a corresponding swell of water without a tendency for the ice to float.
4 Place the reference thermometer in the ice/water mix. Gently lift it and lower it again to ease
any pressure build-up.

NOTE: The bulb has a thin wall to improve the speed of response to temperature changes. It is also
fragile. If pressure is applied the bulb volume is reduced which causes the liquid column to
rise4.

5 Leave for 1 minute for the reading on the thermometer to stabilise.


6 Tap the thermometer gently to minimise any sticking of the meniscus.
7 Record the reading on the appropriate record sheet.
8 The reference thermometer should give a reading of 0°C. If there is a difference of ± 0.1°C or
more the thermometer should be recalibrated.

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Reference no: QSOP 10i4
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www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 2: CALCULATION OF THE UNCERTAINTY OF MEASUREMENT FOR A
CALIBRATED REFERENCE THERMOMETER USED DIRECTLY IN A WATERBATH OR
INCUBATOR
Thermometer Input Source of uncertainty Value Probability Divisor Standard u2
quantity ± distribution uncertainty (u)
± oC
Reference x1 Uncertainty of reference thermometer (from 0.03 Normal 2 0.0150 0.0002
thermometer calibration certificate)
x2 Correction factor 0.03 Rectangular 3 0.0173 0.0003
(from calibration certificate)
x3 Drift since last calibration or ice point 0 Rectangular 3 0 0
x4 Resolution of reading 0 Rectangular 3 0 0
x5 Immersion differences 0 Rectangular 3 0 0
(non-uniformity of bath)
x6 Emergent column temp correction 0 Normal 2 0 0
x7 Repeatability 0 Normal 1 0 0

uc (T) Combined standard uncertainty Normal 0.0229


U Expanded uncertainty Normal (k=2) 0.0458

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


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Reference no: QSOP 10i4
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www.evaluations-standards.org.uk
Email: [email protected]
Result
= u1 + u2 + u3 + u4 + u5 + u6 + u7
2 2 2 2 2 2 2
uc (T) Uncertainty of measurement of thermometer = ± 0.05 oC
= 0.0002 + 0.0003 The reported expanded uncertainty is based on a standard
= 0.0005 uncertainty multiplied by a coverage factor of k=2, providing a level
= 0.0229 of confidence of 95%. The uncertainty evaluation has been carried
out in accordance with UKAS requirements
U = uc (T) x 2
= 0.0029 x 2
= 0.0458

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Reference no: QSOP 10i4
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www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 3: CALCULATION OF THE UNCERTAINTY OF MEASUREMENT FOR A
THERMOMETER THAT IS NOT A CALIBRATED REFERENCE THERMOMETER USED IN A
WATERBATH OR INCUBATOR
Thermometer Input Source of uncertainty Value Probability Divisor Standard u2
quantity ± distribution uncertainty (u)
± oC
Reference x1 Uncertainty of reference thermometer (from 0.03 Normal 2 0.0150 0.0002
thermometer calibration certificate)
x2 Correction factor 0.03 Rectangular 3 0.0173 0.0003
(from calibration certificate)
x3 Drift since last calibration or ice point 0 Rectangular 3 0 0
x4 Resolution of reading 0 Rectangular 3 0 0
x5 Immersion differences 0 Rectangular 3 0 0
(non-uniformity of bath)
x6 Emergent column temp correction 0 Normal 2 0 0
x7 Repeatability 0 Normal 1 0 0
Working x8 Correction factor of working thermometer 0.1 Rectangular 3 0.0577 0.0033
thermometer (obtained from comparison of working
thermometer against reference thermometer)
x9 Drift since last calibration or ice point 0 Rectangular 3 0 0
x10 Resolution of reading 0 Rectangular 3 0 0
x11 Emergent column temp correction 0 Rectangular 3 0 0
x12 Repeatability 0 Normal 1 0 0

uc (T) Combined standard uncertainty Normal 0.0621


U Expanded uncertainty Normal (k=2) 0.1242

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Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 12 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
Result
= u1 + u2 + u3 + u4 + u5 + u6 + u7 + u8 + u9 + u10 + u11 + u12
2 2 2 2 2 2 2 2 2 2 2 2
uc (T) Uncertainty of measurement of thermometer = ± 0.12°C
= 0.0002 + 0.0003 + 0.0033 The reported expanded uncertainty is based on a standard
= 0.0038 uncertainty multiplied by a coverage factor of k=2, providing a level of
= 0.0621 confidence of 95%. The uncertainty evaluation has been carried out
in accordance with UKAS requirements
U = uc (T) x 2
= 0.0621 x 2
= 0.1242

NOTES (applicable to Appendices 2 and 3):

Correction factor (x2 and x8) – if this is not applied in the reading then it must be included in the uncertainty budget

Resolution of reading (x4 and x10) – this is 0 if taken account of when reading the thermometer – see section 6 and Appendix 5. For digital thermometers
the resolution of reading will need to be taken account of in the calculation (eg 0.1°C)

Emergent column temp correction (x6 and x11) – if a partial immersion thermometer is used a correction should be applied for any differences in the
emergent column temperature, as measured, to that stated on its calibration certificate. If this correction is not made then the value must be included in the
uncertainty budget

Repeatability (x7 and x12) – a number of readings (n) should be taken (at least 3) and the standard deviation of these readings calculated. Then divide the
Standard deviation by n

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Reference no: QSOP 10i4
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www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 4: SETTING WORKING TEMPERATURE
RANGES

44.2
43.8

44.1

New “practical” New “theoretical”


TARGET TEMPERATURE 44.0 working range working range
43.9°C - 44.1°C 43.87°C - 44.13°C

43.9

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Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 5: TAKING ACCOUNT OF THE RESOLUTION
OF READING

38.0

37.8
Meniscus between two
37.6 intervals and above target
temperature
Reading = 37.8°C
37.4

37.2
Acceptable range for
TARGET TEMPERATURE 37.0 test
36°C – 38°C
36.8

36.6

36.4 Meniscus between two intervals


and below target temperature
Reading = 36.6°C
36.2

36.0

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Reference no: QSOP 10i4
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www.evaluations-standards.org.uk
Email: [email protected]
APPENDIX 6: ERROR ASSOCIATED WITH PARALLAX

Reading taken with


eye normal
to stem

Reading taken
with incorrect line
of sight

TRACEABILITY AND USE OF THERMOMETERS IN UKAS ACCREDITED LABORATORIES


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Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]
REFERENCES
1. Department of Health NHS Executive: The Caldicott Committee. Report on the review of patient-
identifiable information. London. December 1997.

2. United Kingdom Accreditation Service. Joint ISO-ILAC-IAF Communiqué on the Management


Systems Requirements of ISO/IEC 17025:2005, General Requirements for the competence of
testing and calibration laboratories. http://www.ukas.com/information_centre/publications.asp.

3. United Kingdom Accreditation Service. Traceability of Temperature Measurement. Platinum


Resistance Thermometers, Thermocouples, Liquid-in-glass Thermometers and Radiation
Thermometers. http://www.ukas.com/information_centre/publications.asp.

4. BS 1041: 1985. Temperature measurements. Part 2: Expansion thermometers. Section 2.1: Guide
to selection and use of liquid-in-glass thermometers. Milton Keynes: British Standards Institution
(BSI); 1985.

5. United Kingdom Accreditation Service. The expression of uncertainty and confidence in


measurement. M3003. http://www.ukas.com/information_centre/publications.asp.

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Issue no: 4 Issue date: 14.08.07 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 17 of 17
Reference no: QSOP 10i4
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: [email protected]

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