EN 13486:2023
(Main)Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Periodic verification
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 ambient or internal temperature of 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) and also others used for transport, distribution and/or storage of temperature sensitive goods.
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 zur Messung der Umgebungs- oder Innentemperatur von Produkten zwischen −80 °C und +85 °C fest, die für die Ausrüstung von Transport , Lager- und Verteilungseinrichtungen für temperaturempfindliche Produkte bestimmt sind und den Normen EN 12830 und EN 13485 (Messklassen und Bereiche) entsprechen sowie anderen, die für Transport, Lagerung und/oder Verteilung von temperaturempfindlichen Produkten verwendet werden.
Es legt die Prüfverfahren fest, mit denen die Übereinstimmung der Geräte mit den in EN 12830 und EN 13485 definierten Klassenanforderungen überprüft werden.
ANMERKUNG Beispiele für den Transport, die Lagerung und Verteilung von temperaturempfindlichen Produkten zwischen −80 °C und +85 °C sind gekühlte, gefrorene, tiefgefrorene und schockgefrorene Lebensmittel; Eiscreme; 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 ambiante ou de la température interne des produits entre −80 °C et +85 °C qui sont destinés à équiper les moyens de transport, de stockage et de distribution des marchandises thermosensibles, qui sont conformes aux normes EN 12830 et EN 13485 (classes et étendues de mesure) et qui sont également destinés à équiper d’autres moyens de transport, de distribution et/ou de stockage des marchandises thermosensibles.
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 œuvres 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
Ta dokument določa postopek preverjanja registratorjev temperature in termometrov za merjenje zraka in izdelkov med −80 °C in +85 °C, ki so namenjeni za opremo sredstev za prevoz, skladiščenje in distribucijo toplotno občutljivega blaga in so skladni s standardoma EN 12830 in EN 13485 (razredi in območja merjenja).
Določa preskusne metode, ki omogočajo preverjanje skladnosti opreme z zahtevami glede na razred, ki so določene v standardih EN 12830 in EN 13485.
OPOMBA: Primeri prevoza, skladiščenja in distribucije toplotno občutljivega blaga pri temperaturah od –80 °C do 85 °C so na primer ohlajena, zamrznjena in globoko zamrznjena ter hitro zamrznjena hrana, sladoled, sveža in vroča hrana, farmacevtski izdelki, kri, organi, kemikalije, biološke snovi, elektronske in mehanske naprave, cvetje, rastline, čebulice, surovine in tekočine, živali, izdelki s področja umetnosti in pohištvo.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2024
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 Produkten - 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: EN 13486:2023
ICS:
17.200.20 Instrumenti za merjenje Temperature-measuring
temperature instruments
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 13486
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2023
EUROPÄISCHE NORM
ICS 17.200.20; 67.260 Supersedes 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 Produkten - Regelmäßige
périodique Prüfungen
This European Standard was approved by CEN on 20 November 2023.
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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre 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 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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13486:2023 E
worldwide for CEN national Members.
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 . 5
4 Frequency and kind of verification . 5
5 Method of verification of temperature measurement . 7
5.1 General . 7
5.2 Environmental conditions . 7
5.3 Working standard . 7
5.4 Additional equipment. 7
5.5 Procedure. 7
5.5.1 General . 7
5.5.2 Preliminary operations. 7
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 .11
Annex A (informative) Example of verification report .12
Annex B (informative) Life cycle sheet .14
Annex C (informative) Guidance to determine accordance with this document .15
Annex D (informative) Guidance to determine the expanded uncertainty .16
Bibliography .18
European foreword
This document (EN 13486:2023) 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 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 June 2024, and conflicting national standards shall be
withdrawn at the latest by June 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 13486:2001.
a) enhancement of the scope by defining adapted temperature ranges and broadening it to more
temperature sensitive goods in accordance with EN 12830 and EN 13485;
b) complete revision of Clause 4;
c) addition of class 0,2 to the standard;
d) revision of 5.6;
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) update and clarification of Clause 8 regarding expression of results;
h) addition of Annex C as guideline to the verification process;
i) addition of Annex D as guideline to determine the expanded uncertainty.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Türkiye and the United
Kingdom.
1 Scope
This document specifies the verification procedure for temperature recorders and thermometers for
measuring the ambient or internal temperature of 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) and
also others used for transport, distribution and/or storage of temperature sensitive goods.
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)
JCGM 200:2012, International Vocabulary of Metrology — Basic and general concepts and associated terms
(VIM)
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 12830, EN 13485, the VIM
(JCGM 200:2012) and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1.1
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms
of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.
Available at: https://www.bipm.org/en/committees/jc/jcgm/publications
Note 3 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: EN ISO 9000:2015, 3.8.12]
3.1.2
error of measurement
measured quantity value minus a reference quantity value
[SOURCE: EN 12830:2018, 3.11]
3.1.3
thermometer
any device to measure and display temperature
[SOURCE: EN 13485:2023, 3.2]
3.1.4
temperature sensor
element of a measuring instrument or measuring chain that is directly affected by the temperature
[SOURCE: EN 13485:2023, 3.3]
3.1.5
recording device
part of a measuring instrument that provides a record of an indication
[SOURCE: EN 12830:2018, 3.14]
3.2 Abbreviations
For the purposes of this document, the following abbreviations apply.
AIT Atomic International Time
DUT device under test
GPS global positioning system
MPE maximum permissible error (equal to the equipment class)
NTP network timebase protocol
4 Frequency and kind of verification
The verification shall be done for:
— all new thermometers and recorders,
— in the case of any change of the measurement chain,
— in the case of indicated issues and/or problems or
— in the case of repairs with the measurement system.
The frequency and the type of the checks depends on the requirements of the contracting parties, i.e.
recorder owner and its client(s), taking into account the requirements of the manufacturer and user while
respecting mandatory regulations as well as operational impact or usage like storage/transport,
fresh/frozen, frequently
...
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