prEN 13486

Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Periodic verification

This document specifies the verification procedure for temperature recorders and thermometers for measuring the air and the products between −80 °C and +85 °C, which are intended to equip the means used for the transport, storage and distribution of temperature sensitive goods and which comply with standards EN 12830 and EN 13485 (measurement classes and ranges).
It specifies the test methods which allow the verification of the equipment's conformity against class requirements identified in EN 12830 and EN 13485.
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.

Temperaturregistriergeräte und Thermometer zur Messung der Umgebungs- und Innentemperatur für den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Regelmäßige Prüfungen

Dieses Dokument legt das Verifizierungsverfahren für Temperaturregistriergeräte und Thermometer zum Messen der Luft- und Produkttemperatur zwischen −80 °C und +85 °C fest, die für Transport-, Lager- und Verteilungseinrichtungen von temperaturempfindlichen Produkten bestimmt sind und den Normen EN 12830 und EN 13485 (Messklassen und Bereiche) entsprechen.
Es legt die Prüfverfahren fest, die es ermöglichen, die Übereinstimmung des Gerätes mit den in EN 12830 und EN 13485 definierten Klassenanforderungen zu bestimmen.
ANMERKUNG   Beispiele für den Transport, die Lagerung und Verteilung von temperaturempfindlichen Waren zwischen −80 °C und +85 °C sind gekühlte, gefrorene, tiefgefrorene und schockgefrorene Lebensmittel; Eiskrem; frische und heiße Lebensmittel; Arzneimittel; Blut und Organe; Chemikalien; biologische Produkte; elektronische und mechanische Geräte; Blumen, Pflanzen und Blumenzwiebeln; Rohstoffe und Flüssigkeiten; Tiere; Kunstgegenstände und Mobiliar.

Enregistreurs de température et thermomètres de mesure de la température ambiante ou interne pour le transport, le stockage et la distribution des marchandises thermosensibles - Vérification périodique

Le présent document définit la procédure de vérification des enregistreurs de température et des thermomètres de mesure de la température de l’air et des produits entre −80 °C et +85 °C destinés à équiper les moyens de transport, de stockage et de distribution des marchandises thermosensibles et qui sont conformes aux normes EN 12830 et EN 13485 (classes et étendues de mesure).
Il définit les méthodes d’essai qui permettent de vérifier que l’équipement est conforme aux exigences des classes, identifiées dans l’EN 12830 et l’EN 13485.
NOTE Les marchandises thermosensibles faisant l’objet d’un transport, d’un stockage et d’une distribution entre −80 °C et +85 °C sont par exemple les denrées alimentaires réfrigérées, congelées, surgelées ; les crèmes glacées ; les produits alimentaires frais et chauds ; les produits pharmaceutiques ; le sang et les organes ; les substances chimiques ; les substances biologiques ; les dispositifs électroniques et mécaniques ; les fleurs, les plantes et les bulbes ; les matières premières solides ou liquides ; les animaux ; les oeuvres d’art et le mobilier.

Registratorji temperature in termometri za merjenje temperature okolice ali notranje temperature pri prevozu, skladiščenju in distribuciji toplotno občutljivega blaga - Periodično preverjanje

General Information

• Status: Not Published
• Publication Date: 01-May-2024
• ICS: 17.200.20 - Temperature-measuring instruments
• ICS: 67.260 - Plants and equipment for the food industry
• Technical Committee: CEN/TC 423 - Project Committee - Means of measuring and/or recording temperature in the cold chain
• Drafting Committee: CEN/TC 423/WG 1 - Revision of EN 13485 and EN 13486
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 28-Jun-2023
• Due Date: 04-May-2023
• Completion Date: 28-Jun-2023
• Ref Project: oSIST prEN 13486:2022 - Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Periodic verification

Relations

• Revises: EN 13486:2001 - Temperature recorders and thermometers for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Periodic verification
• Effective Date: 28-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 13486:2022
01-september-2022
Registratorji temperature in termometri za merjenje temperature okolice ali

notranje temperature pri prevozu, skladiščenju in distribuciji toplotno občutljivega

blaga - Periodično preverjanje
Temperature recorders and thermometers for measuring the ambient or internal

temperature for the transport, storage and distribution of temperature sensitive goods -

Periodic verification
Temperaturregistriergeräte und Thermometer zur Messung der Umgebungs- und
Innentemperatur für den Transport, die Lagerung und die Verteilung von
temperaturempfindlichen Waren - Regelmäßige Prüfungen

Enregistreurs de température et thermomètres de mesure de la température ambiante

ou interne pour le transport, le stockage et la distribution des marchandises
thermosensibles - Vérification périodique
Ta slovenski standard je istoveten z: prEN 13486
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 13486:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 13486:2022
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oSIST prEN 13486:2022
DRAFT
EUROPEAN STANDARD
prEN 13486
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 17.200.20; 67.260 Will supersede EN 13486:2001
English Version
Temperature recorders and thermometers for measuring
the ambient or internal temperature for the transport,
storage and distribution of temperature sensitive goods -
Periodic verification

Enregistreurs de température et thermomètres de Temperaturregistriergeräte und Thermometer zur

mesure de la température ambiante ou interne pour le Messung der Umgebungs- und Innentemperatur für

transport, le stockage et la distribution des den Transport, die Lagerung und die Verteilung von

marchandises thermosensibles - Vérification temperaturempfindlichen Waren - Regelmäßige

périodique Prüfungen

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 13486:2022 E

worldwide for CEN national Members.
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oSIST prEN 13486:2022
prEN 13486:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

1 Scope .................................................................................................................................................................... 4

2 Normative references .................................................................................................................................... 4

3 Terms, definitions and abbreviations ..................................................................................................... 4

3.1 Terms and definitions ................................................................................................................................... 4

3.2 Abbreviations ................................................................................................................................................... 6

4 Frequency and kind of verification ........................................................................................................... 6

5 Method of verification of temperature measurement ....................................................................... 7

5.1 General ................................................................................................................................................................ 7

5.2 Environmental conditions ........................................................................................................................... 7

5.3 Working standard ........................................................................................................................................... 8

5.4 Additional equipment.................................................................................................................................... 8

5.5 Procedure........................................................................................................................................................... 8

5.5.1 General ................................................................................................................................................................ 8

5.5.2 Preliminary operations................................................................................................................................. 8

5.5.3 Verification measurement(s) ..................................................................................................................... 8

5.6 Condition of acceptance ................................................................................................................................ 9

6 Method of verification of duration of temperature recordings ...................................................... 9

6.1 General ................................................................................................................................................................ 9

6.2 Verification of recording duration by making a test recording .................................................. 10

6.3 Verification of recording duration by other means ......................................................................... 11

6.4 Conditions of acceptance of duration ................................................................................................... 11

7 Functional test for recorders with cloud Solution as a Service (SaaS) approach regarding

storage and display...................................................................................................................................... 11

8 Expression of results ................................................................................................................................... 12

Annex A (informative) Example of verification report ................................................................................ 13

Annex B (informative) Life cycle sheet .............................................................................................................. 15

Annex C (informative) Guidance to determine accordance with this document ............................... 16

Annex D (informative) Guidance to determine the expanded uncertainty.......................................... 17

Bibliography ................................................................................................................................................................. 19

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oSIST prEN 13486:2022
prEN 13486:2022 (E)
European foreword

This document (prEN 13486:2022) 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 13486:2001.

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 standard;
d) Clause 5.6 has been revised;

e) addition of a new methodology to Clause 6 to account for new technologies for time synchronisation;

f) addition of Clause 7 for functional test of recorders with cloud SaaS for storage and display;

g) Clause 8 regarding expression of results has been updated and clarified;
h) addition of Annex C as guideline to the verification process;
i) addition of Annex D as guideline to determine the expanded uncertainty.
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oSIST prEN 13486:2022
prEN 13486:2022 (E)
1 Scope

This document specifies the verification procedure for temperature recorders and thermometers for

measuring the air and the products between −80 °C and +85 °C, which are intended to equip the means

used for the transport, storage and distribution of temperature sensitive goods and which comply with

standards EN 12830 and EN 13485 (measurement classes and ranges).

It specifies the test methods which allow the verification of the equipment's conformity against class

requirements identified in EN 12830 and EN 13485.

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 12830:2018, Temperature recorders for the transport, storage and distribution of temperature sensitive

goods - Tests, performance, suitability

EN 13485, Thermometers for measuring the ambient or internal temperature for the transport, storage and

distribution of temperature sensitive goods - Tests, performance, suitability

EN ISO 10012, Measurement management systems - Requirements for measurement processes and

measuring equipment (ISO 10012)
3 Terms, definitions and abbreviations

For the purposes of this document, the terms and definitions given in EN 12830, EN 13485 and the

following 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
3.1 Terms and definitions
3.1.1
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]
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oSIST prEN 13486:2022
prEN 13486:2022 (E)
3.1.2
maximum permissible error
limits of permissible error

extreme values of an error permitted by specifications, regulations etc., for a

given measuring instrument
[SOURCE: VIM [1]]
3.1.3
working standard
check standard

standard that is used routinely to calibrate or check material measures, measuring instruments or

reference materials

Note 1 to entry: A working standard is usually calibrated against a reference standard.

Note 2 to entry: A working standard used routinely to ensure that measurements are being carried out correctly is

called a check standard.
[SOURCE: VIM [1]]
3.1.4
error of measurement
measured quantity value minus a reference quantity value
[SOURCE: EN 12830:2018, 3.11]
3.1.5
value

magnitude of a particular quantity generally expressed as a unit of measurement multiplied

by a number
EXAMPLE 15 °C
[SOURCE: VIM [1]]
3.1.6
measurement
set of operations having the object of determining a value of a quantity
[SOURCE: VIM [1]]
3.1.7
uncertainty of measurement

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]]
3.1.8
thermometer
any device to measure and display temperature
Note 1 to entry: See 3.16.
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oSIST prEN 13486:2022
prEN 13486:2022 (E)
3.1.9
temperature sensor

element of a measuring instrument or measuring chain that is directly affected by the temperature

Note 1 to entry: See 3.X.
3.1.10
recording device
part of a measuring instrument that provides a record of an indication
[SOURCE: EN 12830:2018, 3.14]
3.1.11
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]]
3.1.12
resolution

smallest difference between indications of a displaying device that can be

meaningfully distinguished
[SOURCE: VIM [1]]
3.1.13
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]]
3.2 Abbreviations
AIT Atomic International Time
DUT device under test
GPS global positioning system
MPE maximum permissible error
NTP network timebase protocol
4 Frequency and kind of verification

The frequency and the type of the checks depends on the requirements of the contracting parties, taking

into account the requirements of the manufacturer and user while respecting mandatory regulations.

For accuracy class lower than 0,5 particular attention should be given ensuring standard equipment and

uncertainty requirements when verifications are done on-site.

Verification shall allow traceability of the measurement done prior to verifications and that the

equipment is within the specifications for the next period. See Figure 1.
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oSIST prEN 13486:2022
prEN 13486:2022 (E)
Key
1 new recorder - Installation and commissioning
2 verification in accordance to EN 13486
period n
period n+1
n+1
V(n) equipment is conform and ready to operate (Period n)
V(n+1) equipment is conform and ready to operate (Period n+1)
If V(n+1) is successful, measurements on Period n are validated.

If V(n+1) is not successful, measurements on Period n need to be analysed to evaluate potential non-

conformity.
Figure 1 — Timeline for verifications of equipment

Accordance of the equipment to the standard is determined taking into consideration the uncertainty, the

error of measurement plus the uncertainty shall be equal or less than the class of equipment.

A guidance is found in Annex C while Annex D gives guidance to the determination of the expanded

uncertainty.

The applicable kind of verifications for the respective type of equipment is shown in Table 1.

Table 1 — Kind of verifications per type of equipment
Clause Thermometer Recorder
5 X X
6 X
7 X
5 Method of verification of temperature measurement
5.1 General
The method used is the measurement by direct comparison of the ins
...