oSIST prEN 13485:2022

SLOVENSKI STANDARD
oSIST prEN 13485:2022
01-september-2022
Termometri za merjenje temperature okolice ali notranje temperature pri prevozu,
skladiščenju in distribuciji toplotno občutljivega blaga - Preskusi, značilnosti,
ustreznost
Thermometers for measuring the ambient or internal temperature for the transport,
storage and distribution of temperature sensitive goods - Tests, performance, suitability
Thermometer zur Messung der Umgebungs- und Innentemperatur für den Transport, die
Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prüfung,
Leistung, Gebrauchstauglichkeit
Thermomètres de mesure de la température ambiante ou interne pour le transport, le
stockage et la distribution des marchandises thermosensibles - Essais, performance,
aptitude à l’emploi
Ta slovenski standard je istoveten z: prEN 13485
ICS:
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
67.260 Tovarne in oprema za živilsko Plants and equipment for the
industrijo food industry
oSIST prEN 13485:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 13485:2022

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oSIST prEN 13485:2022


DRAFT
EUROPEAN STANDARD
prEN 13485
NORME EUROPÉENNE

EUROPÄISCHE NORM

July 2022
ICS 17.200.20; 67.260 Will supersede EN 13485:2001
English Version

Thermometers for measuring the ambient or internal
temperature for the transport, storage and distribution of
temperature sensitive goods - Tests, performance,
suitability
 Thermometer zur Messung der Umgebungs- und
Innentemperatur für den Transport, die Lagerung und
die Verteilung von temperaturempfindlichen Waren -
Prüfung, Leistung, Gebrauchstauglichkeit
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 423.

If this draft becomes a European Standard, CEN members are bound 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.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 13485:2022 E
worldwide for CEN national Members.

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oSIST prEN 13485:2022
prEN 13485:2022 (E)
Contents Page
European foreword . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements .10
4.1 General .10
4.2 Measuring range .10
4.3 Locking of settings .11
4.4 Load indicator .11
4.5 Degree of protection provided by the enclosure .11
4.6 Electrical safety (if applicable).12
4.7 Operating characteristics linked to external electrical influences .12
4.7.1 External supply voltage (if applicable) .12
4.7.2 Autonomous power supply (if applicable).12
4.7.3 Frequency (AC) (if applicable) .12
4.7.4 Electrical power disturbances and susceptibility to radiated electromagnetic field 13
4.8 Metrological characteristics .13
4.8.1 General .13
4.8.2 Maximum permissible errors and resolution .13
4.8.3 Response time .13
4.9 Usage profiles .13
4.9.1 Climatic environment .13
4.9.2 Mechanical vibrations .14
4.9.3 Shock resistance .14
5 Test methods .14
5.1 Test list .14
5.2 General conditions for tests .14
5.2.1 Pre-tests adjustments .14
5.2.2 Normal atmospheric conditions .15
5.2.3 Reference conditions .15
5.3 Determination of temperature measurement error .15
5.3.1 Test method .15
5.3.2 Expression of results .17
5.4 Determination of response time .17
5.4.1 General .17
5.4.2 Purpose of the test .17
5.4.3 Test methods .18
5.5 Action of influence quantities .18
5.5.1 General .18
5.5.2 Variation in supply voltage (if applicable) .18
5.5.3 Influence of ambient temperature .18
5.5.4 Temperature testing under storage and transport conditions for the thermometer 19
5.5.5 Shock resistance test (if applicable) .19
5.5.6 Mechanical vibrations (if applicable) .20
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5.5.7 Degree of protection provided by enclosure (IP code) . 20
5.5.8 Electrical safety (if applicable) . 20
5.5.9 Dielectric strength (if applicable) . 20
6 Conditions of acceptance . 20
6.1 Requirements . 20
6.2 Operating error limits . 21
7 Designation . 21
8 Marking . 21
9 Initial and periodic verification . 21
Annex A (informative)  Example of data form describing suitability for use of equipment of
a specific series (to be filled in by the manufacturer) . 22
Annex B (normative) Expected operation time and storage capacity . 23
Annex C (informative) Examples for temperature conditions . 24
Annex D (informative) Life cycle sheet . 25
Annex E (informative) Guidance to determine accordance with this document . 26
Annex F (informative) Guidance to determine the expanded uncertainty . 27
Bibliography . 29

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oSIST prEN 13485:2022
prEN 13485:2022 (E)
European foreword
This document (prEN 13485:2022) has been prepared by Technical Committee CEN/TC 423 “Means of
measuring and/or recording temperature in the cold chain”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN enquiry.
This document will supersede EN 13485:2001.
In comparison with the previous edition, the following technical modifications have been made:
a) clarification of the scope;
b) Clause 4 has been completely revised;
c) addition of class 0,2 to the document;
d) Clause 5.1 has been revised;
e) Clause 5.3 has been revised with examples to clarify the process;
f) Clause 5.5.1 and 5.5.3 have been revised;
g) Clauses 7 and 8 have been updated according to the revised clauses;
h) Clause 9 has been revised;
i) addition of Annex B regarding expected operation time and storage capacity;
j) addition of Annex C regarding examples for temperature conditions;
k) addition of Annex D regarding example of a life cycle sheet;
l) addition of Annex E as guideline to the verification process;
m) addition of Annex F as guideline to determine the expanded uncertainty.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
This document meets the objectives of the following directives:
— 92/1/EEC of January 15, 1992 of the Commission of the monitoring of temperatures in the means of
transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption;
(Commission Regulation (EC) No 37/2005 of 12 January 2005 on the monitoring of temperatures in
the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human
consumption with EEA relevance);
— 92/2/EEC of January 13, 1992 of the Commission laying down the sampling procedure and the
community method of analysis for the official control of the temperatures of quick-frozen foods
intended for human consumption;
— 93/43/EEC of June 14, 1993 of the Council of the hygiene of foodstuffs and in particular on
“temperature control criteria” (Regulation (EC) No 852/2004 of the European Parliament and of the
Council of 29 April 2004 on the hygiene of foodstuffs).
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oSIST prEN 13485:2022
prEN 13485:2022 (E)
1 Scope
This document specifies the technical and functional characteristics for all types of thermometers
(electronic, mechanical, etc.) for equipping the means used for the transport, storage and distribution of
temperature sensitive goods and for measuring the ambient or internal temperature of the products
between −80 °C and +85 °C.
It specifies the test methods which allow the verification of the equipment's conformity to suitability and
performance requirements.
It applies to the whole indicator-temperature sensor(s). The temperature sensor(s) can be integrated
into the thermometer or remote from it (external temperature sensor(s)).
It does not define the location of the thermometer and its sensors with respect to types of usage such as
transport, storage and distribution.
NOTE Examples for the transport, storage and distribution of temperature sensitive goods between −80 °C and
+85 °C include chilled, frozen, deep frozen and quick frozen food; ice cream; fresh and hot food; pharmaceuticals;
blood and organs; chemicals; biologicals; electronic and mechanical devices; flowers, plants and bulbs; raw
materials and liquids; animals; art and furnishings.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 60068-2-27, Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
EN 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use -
Part 1: General requirements
EN 61000-6-2, Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial
environments
EN 61000-6-3, Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for
residential, commercial and light-industrial environments
EN 13486, Temperature recorders and thermometers for the transport, storage and distribution of chilled,
frozen, deep-frozen/quick-frozen food and ice cream - Periodic verification
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
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oSIST prEN 13485:2022
prEN 13485:2022 (E)
3.1
quantity
attribute of a phenomenon, body or substance that may be distinguished qualitatively
and determined quantitatively
EXAMPLE Temperature.
[SOURCE: VIM [1]]
3.2
unit
particular quantity, defined and adopted by convention, with which other quantities of
the same kind are compared in order to express their magnitudes relative to that quantity
EXAMPLE The unit of temperature used in this document is “degree Celsius”.
[SOURCE: VIM [1]]
3.3
symbol of a unit
conventional sign designating a unit of measurement
EXAMPLE °C is the symbol of “degree Celsius”.
[SOURCE: VIM [1]]
3.4
value
magnitude of a particular quantity generally expressed as a unit of measurement multiplied
by a number
EXAMPLE 15 °C
[SOURCE: VIM [1]]
3.5
true value
value consistent with the definition of a given particular quantity
Note 1 to entry: This is a value that would be obtained by a perfect measurement.
[SOURCE: VIM [1]]
3.6
measurement
set of operations having the object of determining a value of a quantity
3.7
measurand
particular quantity subject to a measurement
EXAMPLE Temperature.
[SOURCE: VIM [1]]
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3.8
influence quantity
quantity that is not the measurand but that affects the result of the measurement
[SOURCE: VIM [1]]
3.9
indication
value of a quantity provided by a measuring instrument
[SOURCE: VIM [1]]
3.10
accuracy
closeness of the agreement between the result of a measurement and a true value of the
measurand
[SOURCE: VIM [1]]
3.11
uncertainty
parameter, associated with the result of a measurement, which characterizes the
dispersion of the values that could reasonably be attributed to the measurand
[SOURCE: VIM [1]]
3.12
error
result of a measurement minus a true value of the measurand
[SOURCE: VIM [1]]
3.13
relative error
error of a measurement divided by a true value of the measurand
[SOURCE: VIM [1]]
3.14
measuring instrument
device intended to be used to make measurements, alone or in conjunction with supplementary device(s)
[SOURCE: VIM [1]]
3.15
displaying device
indicating device
part of a measuring instrument that displays an indication
[SOURCE: VIM [1]]
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oSIST prEN 13485:2022
prEN 13485:2022 (E)
3.16
thermometer
any device to measure and display temperature
3.17
temperature sensor
element of a measuring instrument or measuring chain that is directly affected by the temperature
3.18
external temperature sensor
sensor which measures a temperature independent of the enclosure of the indicating device
3.19
internal temperature sensor
sensor which measures the temperature of the enclosure of the thermometer
3.20
scale
ordered set of marks, together with any numbering, forming part of a displaying
device of a measuring instrument
[SOURCE: VIM [1]]
3.21
scale division
part of a scale between two successive scale marks
[SOURCE: VIM [1]]
3.22
adjustment
operation of bringing a measuring instrument into a state of performance
suitable for its use
[SOURCE: VIM [1]]
3.23
user adjustment
adjustment employing the means at the disposal of the user
[SOURCE: VIM [1]]
3.24
span
modulus of the difference between the two limits of a nominal range
EXAMPLE For a nominal range of - 35 °C to + 25 °C, the span is 60 °C.
[SOURCE: VIM [1]]
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oSIST prEN 13485:2022
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3.25
measuring range
working range
set of values for which the error of a measuring instrument is intended to lie within specified limits
[SOURCE: VIM [1]]
3.26
rated operating conditions
conditions of use for which specified metrological characteristics of a measuring instrument are intended
to lie within given limits
[SOURCE: VIM [1]]
3.27
limiting conditions
extreme conditions that a measuring instrument is required to withstand without damage, and without
degradation of specified metrological characteristics when it is subsequently operated under its rated
operating conditions
[SOURCE: VIM [1]]
3.28
reference conditions
conditions of use prescribed for testing the performance of a measuring instrument or for comparison of
results of measurements
[SOURCE: VIM [1]]
3.29
resolution
smallest difference between indications of a displaying device that can be
meaningfully distinguished
[SOURCE: VIM [1]]
3.30
response time
time interval between the instant when a stimulus is subjected to a specified abrupt change and the
instant when the response reaches and remains within specified limits around its final steady value
[SOURCE: VIM [1]]
3.31
storage and transport conditions
extreme conditions which a non-operational measuring instrument can withstand without damage and
without degradation of specified metrological characteristics when it is subsequently operated under its
rated operating conditions
3.32
chilled food
food which has been subjected to cooling (without freezing) and is intended to be maintained at low
temperature
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oSIST prEN 13485:2022
prEN 13485:2022 (E)
3.33
frozen food
food which has been subjected to a freezing process specially designed to preserve the wholesomeness
and quality of the product
3.34
deep-frozen or quick-frozen food
food which has been subjected to a quick freezing process
3.35
verification
confirmation and provision of evidence that the specified requirements have been fulfilled
Note 1 to entry: In connection with the management of measuring equipment, verification provides a means for
checking that the deviations between values indicated by a measuring instrument and corresponding known values
of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation
or specification peculiar to the management of the measuring equipment.
Note 2 to entry: The result of verification leads to a decision to either restore to service, perform adjustments,
repair, downgrade, or declare obsolete. A written trace of the verification performed is kept on the measuring
instrument's individual record.
[SOURCE: EN ISO 9000:2015, 3.8.12]
4 Requirements
4.1 General
Manufacturers shall make recommendations on the specification of ancillary equipment in order to meet
the performance requirements of this document.
The manufacturer shall define the use of the transport, storage and operational conditions. Examples are
given in the informative Annex C.
NOTE Further information is included in EN 60721-3-3 and EN 60721-2-3.
The manufacturer shall verify the defined requirements of his applications.
If the system would have the possibilities to prevent and/or detect manipulation and to prove the validity
of the data, it can be validated according to the relevant chapters in EN 12830.
4.2 Measuring range
— The temperature sensor shall be able to measure the air and/or product temperature in the
measuring range that it is defined by the manufacturer;
— The thermometers shall be able to indicate the air and/or product temperature which is extended
twice the maximum permissible error for the maximum defined class of the temperature sensor
stated by the manufacturer in both directions, see 4.8.2;
— For climate classes, see the relevant legislation and quality specifications.
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oSIST prEN 13485:2022
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4.3 Locking of settings
The means for adjusting settings of the thermometer shall either:
— be protected against accidental or unauthorised modifications; and/or
— record each adjustment of any settings that remain accessible.
4.4 Load indicator
For devices with an autonomous power supply, this shall be indicated on the thermometers or on the
power supply or in the technical documentation, with the corresponding usage temperature.
The manufacturer shall install an indicating device, warning light or message on the device or remote,
warning the user that the power source needs replacing.
The manufacturer shall avoid any measurement when the charge of the battery is too low.
The manufacturer shall declare operational limitations as indicated in Annex B.
The battery lifetime shall be indicated by the manufacturer for relevant operation temperatures taking
into account typical operation of e.g. display, transmission of data, LEDs, number and kind of sensors.
The manufacturer shall indicate, if the battery is fixed or replaceable and/or rechargeable.
4.5 Degree of protection provided by the enclosure
The degree of protection provided by the enclosure (see Table 1) shall be:
— IP 20 for thermometers used in heated/air-conditioned closed premises or in the cabin of transport
vehicles;
— IP 55 for thermometers used inside cold enclosures (storage or transport vehicles), for external
sensor and portable apparatus;
— IP 65 for thermometers used outside the buildings or vehicles, with sensors inside the cold enclosure
or other operational requirements like hygienic and cleaning or maintenance aspects.
For multi-purpose devices, the highest level will be required.
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oSIST prEN 13485:2022
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Table 1 — Degree of protection
 Product internal
Air temperature
temperature
Indicating Indicating
Sensor Sensor
device device
in heated/air-conditioned closed premises
NA IP 20 IP 65 IP 20
a
or in the cabin of transport vehicles
inside cold enclosures (storage or
IP 55 IP 55 IP 65 IP 55
a
transport vehicles)
outside the buildings or vehicles, with
IP 65 IP 65 IP 65 IP 65
b
sensors inside the cold enclosure
c
Calibration in bath (liquid) IP 67 NA IP 67 NA
d
IP 65 IP 65 IP 65 IP 65
Liquid cleaning
a
Non-condensing humidity conditions.
b
Condensing humidity conditions.
c
Includes liquids like alcohol, glycol, oil, sand etc.
d
Disinfection.
NOTE 1 Further requirements regarding the degree of protection are provided in EN 60529.
NOTE 2 Additional requirements regarding the degree of protection are also provided in ISO 20653.
4.6 Electrical safety (if applicable)
The thermometer shall be in accordance with the requirements of EN 61010-1.
4.7 Operating characteristics linked to external electrical influences
4.7.1 External supply voltage (if applicable)
A thermometer which requires an external electrical supply shall be able to be connected to one of the
electrical supplies given in Table 2.
Table 2 — External supply voltage
Alternating current (AC) U +10 %, −15 %
n
Direct current (DC) U Rated operating conditions Limiting conditions
n
9 V 6 V to 12 V 0 V to 14 V
12 V 10 V to 16 V 0 V to 18 V
24 V 20 V to 32 V 0 V to 36 V
4.7.2 Autonomous power supply (if applicable)
The manufacturer shall specify the operating time without external power at a reference temperature.
4.7.3 Frequency (AC) (if applicable)
The manufacturer shall specify the operating frequency with a tolerance of ± 3 Hz.
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4.7.4 Electrical power disturbances and susceptibility to radiated electromagnetic field
The thermometer shall be in accordance to the requirements of EN 61000-6-2 and EN 61000-6-3, or any
other specific standard if applicable.
4.8 Metrological characteristics
4.8.1 General
The metrological characteristics of the thermometers result from usage profiles which determine the
operating criteria.
4.8.2 Maximum permissible errors and resolution
The thermometers under rated operating conditions shall be in accordance to one of the classes indicated
in Table 3.
Table 3 — Accuracy classes of thermometers
Class 0,2 0,5 1 2
Maximum permissible errors ±0,2 °C ±0,5 °C ±1 °C ±2 °C
Resolution < 0,1 °C < 0,2 °C ≤ 0,5 °C ≤ 1 °C
4.8.3 Response time
4.8.3.1 Th
...