EN 13485:2023
(Main)Thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability
Thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability
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 thermometer and indicating device(s). The temperature sensor(s) can be integrated into the thermometer or remote from it (wired or wireless external temperature sensor(s)).
It does not specify 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.
Thermometer zur Messung der Umgebungs- und Innentemperatur für den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prüfung, Leistung, Gebrauchstauglichkeit
Dieses Dokument legt die technischen und funktionalen Eigenschaften von Thermometern jeder Art (elektronischen, mechanischen usw.) fest, die für Transport-, Lager- und Verteilung von temperaturempfindlichen Produkten und für die Messung der Umgebungs- und Innentemperatur von Produkten zwischen −80 °C und +85 °C bestimmt sind.
Es legt die Prüfverfahren fest, die es ermöglichen, die Übereinstimmung der Geräte mit den Leistungs- und Gebrauchstauglichkeitsanforderungen zu bestimmen.
Es bezieht sich auf das gesamte Thermometer und die gesamte(n) Anzeigeeinrichtung(en). Der/die Temperaturaufnehmer kann/können in das Thermometer integriert oder davon getrennt sein (drahtgebundene(r) oder drahtlose(r) externe(r) Temperaturaufnehmer).
Es legt nicht die Position des Thermometers und seiner Temperaturaufnehmer im Hinblick auf die Nutzungsarten wie Transport, Lagerung und Verteilung fest.
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.
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
Le présent document définit les caractéristiques techniques et fonctionnelles de tous les types de thermomètres (électroniques, mécaniques, etc.) destinés à équiper les moyens de transport, de stockage et de distribution des marchandises thermosensibles et à mesurer la température ambiante ou la température interne des produits entre −80 °C et +85 °C.
Il spécifie les méthodes d’essai qui permettent de vérifier la conformité du matériel aux spécifications d’aptitude à l’emploi et de performance.
Il s’applique à l’ensemble du thermomètre et aux dispositifs de type indicateurs de température. Le ou les capteurs de température peuvent être intégrés au thermomètre ou se trouver à distance de ce dernier (capteurs externes de température filaires ou sans fil).
Il ne spécifie pas l’emplacement du thermomètre ou des capteurs de ce dernier en fonction des types d’utilisation tels que le transport, le stockage ou la distribution.
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.
Termometri za merjenje temperature okolice ali notranje temperature pri prevozu, skladiščenju in distribuciji toplotno občutljivega blaga - Preskusi, značilnosti, ustreznost
Ta dokument določa tehnične in funkcionalne lastnosti vseh vrst termometrov (elektronskih, mehanskih itd.) za opremljanje sredstev, ki se uporabljajo za prevoz, skladiščenje in distribucijo toplotno občutljivega blaga in za merjenje temperature okolja in notranje temperature izdelkov med –80 °C in +85 °C.
Določa preskusne metode, ki omogočajo preverjanje skladnosti opreme glede, primernosti in zmogljivosti.
Uporablja se za celoten sistem tipala/tipal temperature. Uporabljena temperaturna tipala so lahko vgrajena v termometer ali ne (zunanja temperaturna tipala).
Ne določa lokacije termometra in njegovih tipal v povezavi z vrstami uporabe, kot so prevoz, skladiščenje in distribucija.
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2024
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: EN 13485:2023
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 13485
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2023
EUROPÄISCHE NORM
ICS 17.200.20; 67.260 Supersedes 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
Thermomètres de mesure de la température ambiante Thermometer zur Messung der Umgebungs- und
ou interne pour le transport, le stockage et la Innentemperatur für den Transport, die Lagerung und
distribution des marchandises thermosensibles - die Verteilung von temperaturempfindlichen
Essais, performance, aptitude à l'emploi Produkten - Prüfung, Leistung, Gebrauchstauglichkeit
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 13485:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements . 8
4.1 General . 8
4.2 Measuring range . 8
4.3 Locking of settings . 8
4.4 Load indicator . 8
4.5 Degree of protection provided by the enclosure . 9
4.6 Electrical safety (if applicable). 9
4.7 Operating characteristics linked to external electrical influences .10
4.7.1 External supply voltage (if applicable) .10
4.7.2 Autonomous power supply (if applicable).10
4.7.3 Frequency (AC) (if applicable) .10
4.7.4 Electrical power disturbances and susceptibility to radiated electromagnetic field 10
4.8 Metrological characteristics .10
4.8.1 General .10
4.8.2 Maximum permissible errors and resolution .10
4.8.3 Response time .11
4.9 Usage profiles .11
4.9.1 Climatic environment .11
4.9.2 Mechanical vibrations .11
4.9.3 Shock resistance .11
5 Test methods .11
5.1 Test list .11
5.2 General conditions for tests .12
5.2.1 Pre-tests adjustments .12
5.2.2 Normal atmospheric conditions .12
5.2.3 Reference conditions .12
5.3 Determination of temperature measurement error .13
5.3.1 Test method .13
5.3.2 Expression of results .14
5.4 Determination of response time .15
5.4.1 General .15
5.4.2 Purpose of the test .15
5.4.3 Test methods .15
5.5 Action of influence quantities .16
5.5.1 General .16
5.5.2 Variation in external supply voltage (if applicable) .16
5.5.3 Influence of ambient temperature .16
5.5.4 Temperature testing under storage and transport conditions for the thermometer 17
5.5.5 Shock resistance test (if applicable) .17
5.5.6 Mechanical vibrations (if applicable) .17
5.5.7 Degree of protection provided by enclosure (IP code) .18
5.5.8 Electrical safety (if applicable).18
5.5.9 Dielectric strength (if applicable) .18
6 Conditions of acceptance .18
6.1 Requirements . 18
6.2 Maximum permissible errors . 18
7 Designation . 18
8 Marking . 19
9 Periodic verification . 19
Annex A (informative) Example of data form describing suitability for use of equipment of a
specific series (to be filled in by the manufacturer) . 20
Annex B (normative) Expected operation time and storage capacity . 21
B.1 Battery lifetime dependent on usage . 21
B.2 Minimum power supply voltage . 21
Annex C (informative) Examples for temperature conditions . 22
Annex D (informative) Life cycle sheet . 23
Annex E (informative) Guidance to determine accordance with this document . 24
Annex F (informative) Guidance to determine the expanded uncertainty . 25
Bibliography . 27
European foreword
This document (EN 13485:2023) 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 13485:2001.
a) clarification of the scope;
b) complete revision of Clause 4;
c) addition of class 0,2 to the document;
d) revision of 5.1;
e) revision of 5.3 with examples to clarify the process;
f) revision of 5.5.1 and 5.5.3;
g) update of Clauses 7 and 8 according to the revised clauses;
h) revision of Clause 9;
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 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;
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