Temperature recorders for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability

This European Standard specifies the technical and functional characteristics of temperature recorders for the transport, storage and distribution of temperature sensitive goods between -80 °C and +85 °C.
It specifies the test methods which allow the determination of the equipment's conformity, suitability and performance requirements.
It applies to the whole temperature recording system. The temperature sensor(s) may be integrated into the recorder or be remote from it [external sensor(s)].
It gives some requirements with regards to the location of sensors of the recorder 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 are chilled, frozen and deep frozen, quick frozen food, ice cream, fresh and hot food, pharmaceuticals, blood, organs, chemicals, biologicals, electronic and mechanical devices, flowers, plants, bulbs, raw materials and liquids, animals, art and furnishing.

Temperaturregistriergeräte für den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prüfungen, Leistung, Gebrauchstauglichkeit

Diese Europäische Norm legt die technischen und funktionalen Eigenschaften von Temperatur-registriergeräten fest, die für den Transport, die Lagerung und die Verteilung von wärmeempfindlichen Waren zwischen −80 °C und +85 °C bestimmt sind.
Sie legt die Prüfverfahren fest, die es ermöglichen, die Übereinstimmung des Gerätes mit den Leistungs- und Gebrauchstauglichkeitsanforderungen zu bestimmen.
Sie bezieht sich auf das gesamte System der Temperaturregistrierung. Die Temperaturaufnehmer können in das Registriergerät integriert oder von diesem getrennt sein (externer Aufnehmer).
Sie enthält ebenfalls einige Anforderungen in Bezug auf die Verortung von Aufnehmern des Registriergerätes in Bezug auf die Nutzungsarten, wie Transport, Lagerung und Verteilung.
ANMERKUNG   Beispiele für den Transport, die Lagerung und Verteilung von temperaturempfindlichen Waren zwischen −80 °C und +85 °C sind gekühlte, gefrorene, tiefgekühlte sowie tiefgefrorene Lebensmittel, Eiskrem, frische und heiße Lebensmittel, Arzneimittel, Blut, Organe, Chemikalien, biologische Produkte, elektronische und mechanische Geräte, Blumen, Pflanzen, Glühbirnen, Rohstoffe und Flüssigkeiten, Tiere, Kunstgegenstände und Mobiliar.

Enregistreurs de température pour le transport, le stockage et la distribution des marchandises thermosensibles - Essais, performance, aptitude à l’emploi

La présente Norme européenne spécifie les caractéristiques techniques et fonctionnelles des enregistreurs de température destinés au transport, au stockage et à la distribution des marchandises sensibles aux températures comprises entre - 80 °C et + 85 °C.
Elle spécifie les méthodes d'essai permettant la détermination des exigences de conformité, d'aptitude et de performance de l'équipement.
Elle s’applique à l’ensemble du système enregistreur de température. Le(s) capteur(s) de température peu(ven)t être intégré(s) à l’enregistreur ou se trouver à distance de ce dernier [capteur(s) externe(s)].
Elle spécifie plusieurs exigences concernant l’emplacement des capteurs de l’enregistreur en fonction des différents types d’utilisation tels que le transport, le stockage et la distribution.
NOTE   Des exemples de marchandises sensibles à des températures de transport, de stockage et de distribution comprises entre - 80 °C et + 85 °C sont les denrées réfrigérées, congelées et surgelées, les crèmes glacées, les denrées fraîches et chaudes, les produits pharmaceutiques, le sang, les organes, les produits chimiques, les matières biologiques, les dispositifs électroniques et mécaniques, les fleurs, les plantes, les bulbes, les matières premières et les liquides, les animaux, les œuvres d’art et l’ameublement.

Registratorji temperature za prevoz, skladiščenje in prodajo blaga, občutljivega za toploto - Preskusi, značilnosti, primernost

Ta evropski standard določa tehnične in funkcionalne lastnosti registratorjev temperature za prevoz, skladiščenje in prodajo blaga, občutljivega za toploto pri temperaturah od –80 °C do 85 °C.
Določa preskusne metode, ki omogočajo določanje skladnosti, primernosti in zmogljivosti opreme.
Uporablja se za celoten sistem za beleženje temperature. Uporabljena temperaturna tipala so lahko vgrajena v registrator ali ne [zunanja tipala].
Določa nekatere zahteve glede lokacije tipal registratorjev v povezavi z vrstami uporabe, kot so prevoz, skladiščenje in distribucija.
OPOMBA Primeri prevoza, skladiščenja in distribucije blaga, občutljivega za toploto, pri temperaturah od –80 °C do 85 °C so 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

Status
Published
Public Enquiry End Date
31-May-2017
Publication Date
03-Sep-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Aug-2018
Due Date
13-Oct-2018
Completion Date
04-Sep-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Temperaturregistriergeräte für den Transport, die Lagerung und die Verteilung von temperaturempfindlichen Produkten - Prüfungen, Leistung, GebrauchstauglichkeitEnregistreurs de température pour le transport, le stockage et la distribution des marchandises thermosensibles - Essais, performance, aptitude à l’emploiTemperature recorders for the transport, storage and distribution of temperature sensitive goods - Tests, performance, suitability67.260Tovarne in oprema za živilsko industrijoPlants and equipment for the food industry17.200.20Instrumenti za merjenje temperatureTemperature-measuring instrumentsICS:Ta slovenski standard je istoveten z:EN 12830:2018SIST EN 12830:2018en,fr,de01-oktober-2018SIST EN 12830:2018SLOVENSKI

STANDARDSIST EN 12830:20011DGRPHãþD
SIST EN 12830:2018
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12830
August
t r s z ICS
s yä t r rä t râ
x yä t x r Supersedes EN
s t z u rã s { { {English Version

Temperature recorders for the transportá storage and distribution of temperature sensitive goods æ Testsá performanceá suitability Enregistreurs de température pour le transportá le stockage et la distribution des marchandises thermosensibles æ Essaisá performanceá aptitude à l 5emploi

Temperaturregistriergeräte für den Transportá die Lagerung und die Verteilung von temperaturempfindlichen Produkten æ Prüfungená Leistungá Gebrauchstauglichkeit This European Standard was approved by CEN on

t March
t r s zä

egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels

t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s t z u rã t r s z ESIST EN 12830:2018

EN 12830:2018 (E) 2 Contents Page European foreword ....................................................................................................................................................... 5 1 Scope .................................................................................................................................................................... 6 2 Normative references .................................................................................................................................... 6 3 Terms and definitions ................................................................................................................................... 7 4 Concepts .......................................................................................................................................................... 11 4.1 General ............................................................................................................................................................. 11 4.2 Temperature recorder elements ............................................................................................................ 12 4.3 Temperature recorder architecture (or configuration) ................................................................ 12 4.3.1 General ............................................................................................................................................................. 12 4.3.2 Monolithic instrument ............................................................................................................................... 13 4.3.3 Monolithic instrument with external relevant data ........................................................................ 13 4.3.4 Temperature recorder with digital probes ........................................................................................ 14 4.3.5 Temperature recorder on the cloud ..................................................................................................... 15 5 Requirements ................................................................................................................................................ 16 5.1 General ............................................................................................................................................................. 16 5.2 Measuring range ........................................................................................................................................... 17 5.3 Protection of the data from manipulation .......................................................................................... 17 5.3.1 General ............................................................................................................................................................. 17 5.3.2 Audit trail ........................................................................................................................................................ 17 5.3.3 Clearly readable data copies .................................................................................................................... 17 5.3.4 Safekeeping of accessibility of the data ............................................................................................... 17 5.3.5 Safekeeping of readability of the data .................................................................................................. 18 5.3.6 Safekeeping of correctness of the data ................................................................................................. 18 5.3.7 Access restrictions ....................................................................................................................................... 18 5.3.8 Detailed documentation of the software ............................................................................................. 18 5.4 Locking of settings ....................................................................................................................................... 18 5.5 Recording ........................................................................................................................................................ 18 5.5.1 General ............................................................................................................................................................. 18 5.5.2 Traceability .................................................................................................................................................... 18 5.5.3 Chart only for mechanical recorder ...................................................................................................... 19 5.6 Autonomous power supply ....................................................................................................................... 19 5.7 Degree of protection provided by the enclosure .............................................................................. 19 5.8 Electrical safety (if applicable)................................................................................................................ 19 5.9 Operating characteristics linked to external electrical influences ............................................ 20 5.9.1 External supply voltage (if applicable) ................................................................................................ 20 5.9.2 Autonomous supply (if applicable) ....................................................................................................... 20 5.9.3 Frequency (AC) (if applicable) ................................................................................................................ 20 5.9.4 Power cut-offs ................................................................................................................................................ 20 5.9.5 Electrical power disturbances and susceptibility to radiated electromagnetic field ......... 20 5.10 Metrological characteristics and usage profiles ............................................................................... 20 5.10.1 General ............................................................................................................................................................. 20 5.10.2 Metrological characteristics ..................................................................................................................... 20 5.10.3 Usage profiles ................................................................................................................................................ 22 5.11 Data security .................................................................................................................................................. 22 SIST EN 12830:2018

EN 12830:2018 (E) 3 5.12 Software verification levels ...................................................................................................................... 22 6 Test methods .................................................................................................................................................. 23 6.1 Test list ............................................................................................................................................................. 23 6.2 General conditions for tests ...................................................................................................................... 24 6.2.1 Pre-tests adjustments ................................................................................................................................. 24 6.2.2 Normal atmospheric conditions .............................................................................................................. 24 6.2.3 Reference conditions ................................................................................................................................... 24 6.3 Determination of temperature measurement error ....................................................................... 25 6.3.1 Test method .................................................................................................................................................... 25 6.3.2 Reading the recording ................................................................................................................................ 25 6.3.3 Expression of results ................................................................................................................................... 25 6.4 Determination of response time ............................................................................................................. 26 6.5 Determination of time recording error ................................................................................................ 26 6.6 Action of influence quantities .................................................................................................................. 27 6.6.1 General ............................................................................................................................................................. 27 6.6.2 Variation in voltage supply (if applicable) .......................................................................................... 27 6.6.3 Influence of ambient temperature ......................................................................................................... 27 6.6.4 Temperature testing under storage and transport conditions for the recorder .................. 28 6.6.5 Shock resistance test (if applicable) ...................................................................................................... 28 6.6.6 Mechanical vibrations (if applicable).................................................................................................... 28 6.6.7 Degrees of protection provided by enclosures (IP Code) .............................................................. 29 6.6.8 Electrical safety (if applicable) ................................................................................................................ 29 6.6.9 Dielectric strength (if applicable) .......................................................................................................... 29 6.7 Software test ................................................................................................................................................... 29 6.7.1 Test objective ................................................................................................................................................. 29 6.7.2 Test procedure .............................................................................................................................................. 29 7 Conditions of acceptance ........................................................................................................................... 33 7.1 Requirements ................................................................................................................................................. 33 7.2 Operating error limits ................................................................................................................................. 33 8 Marking ............................................................................................................................................................ 34 9 Initial and periodic verification .............................................................................................................. 34 Annex A (normative)

Software testing ................................................................................................................. 35 A.1 Software test general part – Test objective ......................................................................................... 35 A.2 Test procedure .............................................................................................................................................. 35 A.2.1 General ............................................................................................................................................................. 35 A.2.2 Determine the temperature recorder subunits ................................................................................ 35 A.2.3 Determine the relevant software of each unit or subunit.............................................................. 35 A.2.4 Define the applicable test blocks of each unit or subunit .............................................................. 35 A.2.5 Determine the type of each unit or subunit ........................................................................................ 36 A.3 Software test for type P1 and type P2 ................................................................................................... 37 A.3.1 General ............................................................................................................................................................. 37 A.3.2 Block G: Basic requirements ..................................................................................................................... 37 A.3.3 Block L: Specific software requirements for long-term storage .................................................. 48 A.3.4 Block T: Transmission of measurement data via Communication Networks......................... 55 SIST EN 12830:2018

EN 12830:2018 (E) 4 A.3.5 Block S: Software separation ................................................................................................................... 61 A.3.6 Block D: Download of relevant software ............................................................................................. 64 A.4 Software test for type P3 ........................................................................................................................... 69 Annex B (informative)

Manufacturer software test form ............................................................................. 70 B.1 Identification ................................................................................................................................................. 70 B.1.1 Manufacturer identification ..................................................................................................................... 70 B.1.2 Test object ....................................................................................................................................................... 70 B.1.3 Documents list ............................................................................................................................................... 70 B.1.4 Define the applicable test blocks of each unit or subunit (L, T, S and D) ................................. 71 B.1.5 Selection of the type of each unit or subunit ...................................................................................... 71 B.2 Test requirement for type P1 and P2 .................................................................................................... 73 B.2.1 General ............................................................................................................................................................. 73 B.2.2 Basic requirements ..................................................................................................................................... 73 B.2.3 Extension L: Specific software requirements for long term storage ......................................... 80 B.2.4 Extension T: Specific software requirements for data transmission ........................................ 84 B.2.5 Extension S: Specific software requirements for software separation ..................................... 87 B.2.6 Extension D: Specific software requirements .................................................................................... 89 B.3 Test requirement for type P3 .................................................................................................................. 93 Annex C (informative)

Example of data form describing suitability for use of equipment of a specific series (to be filled in by the manufacturer)........................................................................ 94 Annex D (informative)

Expected operation time and storage capacity ................................................... 95 D.1 Storage capacity dependent on the measurement interval .......................................................... 95 D.2 Battery lifetime dependent on usage .................................................................................................... 95 Annex E (informative)

Required access to recorded data or functions is given in Table E.1 .......... 96

SIST EN 12830:2018

EN 12830:2018 (E) 5 European foreword This document (EN 12830:2018) 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 February 2019 and conflicting national standards shall be withdrawn at the latest by February 2019. 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 12830:1999. The standard has been completely revised and updated to the state of the art as follows: — Scope was enlarged, i.e. location of sensors of the recorder with respect to types of usage are included now; — Update of Clause 2 "Normative references";

— Update of Clause 3 "Terms and definitions"; — Clause 4 "Concepts" was added; — Clause 5 "Requirements" was enlarged, i.e. subclause 5.3 "Protection of the data from manipulation" and 5.12 "Software verification levels" were added and furthermore Clause 5 has been updated, e.g. values for maximum relative timing error and response time

; — New subclause 6.7 "Software test" and the related Annex A "Software testing" and Annex B "Manufacturer software test form" were added; — New Annex D "Expected operation time and storage capacity" and Annex E "Required access to recorded data or functions" were added. This European Standard is a document meeting the objectives of Directives: — 92/1/EEC of January 13, 1992 of the Commission on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs 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”. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 12830:2018

EN 12830:2018 (E) 6 1 Scope This document specifies the technical and functional characteristics of temperature recorders for the transport, storage and distribution of temperature sensitive goods between

« z r °C and +85 °C. It specifies the test methods which allow the determination of the equipment's conformity, suitability and performance requirements. It applies to the whole temperature recording system. The temperature sensor(s) may be integrated into the recorder or be remote from it [external sensor(s)]. It gives some requirements with regards to the location of sensors of the recorder with respect to types of usage such as transport, storage and distribution. NOTE Examples for the transportá storage and distribution of temperature sensitive goods between

« z r °C and +85 °C are chilled, frozen and deep frozen, quick frozen food, ice cream, fresh and hot food, pharmaceuticals, blood, organs, chemicals, biologicals, electronic and mechanical devices, flowers, plants, bulbs, raw materials and liquids, animals, art and furnishing. 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 13486, Temperature recorders and thermometers for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Periodic verification EN 60529, Degrees of protection provided by enclosures (IP Code) (IEC 60529) EN 61000-6-2, Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial environments (IEC 61000-6-2) EN 61000-6-3, Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for residential, commercial and light-industrial environments (IEC 61000-6-3) EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1) ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories ISO/IEC 27001, Information technology - Security techniques - Information security management systems - Requirements SIST EN 12830:2018

EN 12830:2018 (E) 7 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 http://www.electropedia.org/

ISO Online browsing platform: available at http://www.iso.org/obp 3.1 quantity property of a phenomenon, body, or substance, where the property has a magnitude that can be expressed as a number and a reference 3.2 unit of measurement 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 standard is “degree Celsius”. 3.3 value of a quantity number and reference together expressing magnitude of a quantity EXAMPLE 15 °C. 3.4 measurement set of operations having the object of determining a value of a quantity 3.5 measurand particular quantity subject to a measurement EXAMPLE Temperature. 3.6 influence quantity quantity that, in a direct measurement, does not affect the quantity that is actually measured, but affects the relation between the indication and the measurement result 3.7 indication (of a measuring instrument) value of a quantity provided by a measuring instrument 3.8 accuracy class class of measuring instruments of measuring systems that meet stated metrological requirements that are intended to keep measurement errors or instrumental measurement uncertainties within specified limits under specified operating conditions SIST EN 12830:2018

EN 12830:2018 (E) 8 3.9 maximum permissible measurement error maximum permissible error extreme value of measurement error, with respect to a known reference quantity value, permitted by specifications or regulations for a given measurement, measuring instrument, or measuring system 3.10 measurement uncertainty non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used 3.11 error of measurement measured quantity value minus a reference quantity value 3.12 measuring instrument device intended to be used to make measurements, alone or in conjunction with supplementary device(s) 3.13 displaying device indicating device part of a measuring instrument that displays an indication 3.14 recording device part of a measuring instrument that provides a record of an indication 3.15 temperature sensor element of a measuring instrument or measuring chain that is directly affected by the temperature 3.16 scale scale of a measuring instrument ordered set of marks, together with any numbering, forming part of a displaying device of a measuring instrument 3.17 adjustment adjustment of a measuring instrument operation of bringing a measuring instrument into a state of performance suitable for its use 3.18 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 K. SIST EN 12830:2018

EN 12830:2018 (E) 9 3.19 measuring range working range set of values for which the error of a measuring instrument is intended to lie within specified limits 3.20 rated operating conditions operating condition that has to be fulfilled during measurement in order that a measuring instrument or measuring system perform as designed 3.21 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 3.22 reference conditions operating condition prescribed for evaluating the performance of a measuring instrument or measuring system or for comparison of measurement results 3.23 resolution (of a displaying device) smallest difference between indications of a displaying device that can be meaningfully distinguished 3.24 response time time needed for the recorded value to reach and remain with specified limits around actual temperature to which it is measuring 3.25 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 3.26 chilled application application which has been subjected to cooling (without freezing) and is intended to be maintained at low temperature 3.27 frozen food food which has been subjected to a freezing process specially designed to preserve the wholesomeness and quality of the product 3.28 deep-frozen or quick-frozen food food which has been subjected to a quick freezing process 3.29 recording interval time interval that has elapsed between two successively stored measurements SIST EN 12830:2018

EN 12830:2018 (E) 10 3.30 recording duration time interval between the beginning and the end of the recording 3.31 chart tape, disk, form or other structure upon which is recorded the measurand 3.32 duration of transport time interval between loading and unloading 3.33 subunit distinct part or component

of the temperature recorder that generates, encodes, transports, prints, indicates and/or stores relevant data

Note 1 to entry: It is housed in its own enclosure. 3.34 audit trail chronological record that re

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