Enregistreurs de temperature pour le transport,
le stockage et la distribution des marchandises thermosensibles – Essais, performance, aptitude à l'emploi

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

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Contents

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Evropská předmluva........................................................................................................................................................................ 7

1......... Předmět normy..................................................................................................................................................................... 8

2......... Citované dokumenty........................................................................................................................................................... 8

3......... Termíny a definice............................................................................................................................................................... 9

4......... Pojmy................................................................................................................................................................................... 14

4.1...... Obecně................................................................................................................................................................................ 14

4.2...... Prvky záznamníku teploty................................................................................................................................................ 14

4.3...... Architektura teplotního záznamového zařízení
(nebo konfigurace)............................................................................................................................................................ 16

4.3.1... Obecně................................................................................................................................................................................ 16

4.3.2... Monolitický přístroj............................................................................................................................................................. 16

4.3.3... Monolitický přístroj s externími relevantními daty........................................................................................................ 17

4.3.4... Záznamové zařízení teploty s digitálními sondami..................................................................................................... 18

4.3.5... Záznamové zařízení teploty na cloudu.......................................................................................................................... 20

5......... Požadavky........................................................................................................................................................................... 21

5.1...... Obecně................................................................................................................................................................................ 21

5.2...... Měřicí rozsah...................................................................................................................................................................... 22

5.3...... Ochrana dat před manipulací.......................................................................................................................................... 22

5.3.1... Obecně................................................................................................................................................................................ 22

5.3.2... Auditní stopa....................................................................................................................................................................... 22

5.3.3... Jasně čitelné datové kopie.............................................................................................................................................. 22

5.3.4... Úschova přístupnosti dat.................................................................................................................................................. 23

5.3.5... Úložiště čitelnosti dat........................................................................................................................................................ 23

5.3.6... Úložiště správnosti dat...................................................................................................................................................... 23

5.3.7... Omezení přístupu.............................................................................................................................................................. 23

5.3.8... Podrobná dokumentace softwaru.................................................................................................................................. 23

5.4...... Blokování nastavení.......................................................................................................................................................... 23

5.5...... Zaznamenávání dat.......................................................................................................................................................... 24

5.5.1... Obecně................................................................................................................................................................................ 24

5.5.2... Návaznost........................................................................................................................................................................... 24

5.5.3... Nosič záznamu pouze pro mechanické
záznamové zařízení.......................................................................................................................................................... 24

5.6...... Nezávislý napájecí zdroj.................................................................................................................................................. 24

5.7...... Stupeň ochrany krytem..................................................................................................................................................... 25

5.8...... Elektrická bezpečnost (je-li vhodná).............................................................................................................................. 25

5.9...... Provozní charakteristiky spojené s vnějšími elektrickými vlivy................................................................................. 25

5.9.1... Vnější napájecí napětí (je-li vhodné)............................................................................................................................. 25

5.9.2... Nezávislé napájení (je-li vhodné)................................................................................................................................... 26

5.9.3... Frekvence (AC) (je-li vhodná)......................................................................................................................................... 26

5.9.4... Přerušení napájení............................................................................................................................................................ 26

European foreword.......................................................................................................................................................................... 7

1......... Scope..................................................................................................................................................................................... 8

2......... Normative references......................................................................................................................................................... 8

3......... Terms and definitions......................................................................................................................................................... 9

4......... Concepts............................................................................................................................................................................. 14

4.1...... General................................................................................................................................................................................ 14

4.2...... Temperature recorder elements..................................................................................................................................... 14

4.3...... Temperature recorder architecture
(or configuration)............................................................................................................................................................... 16

4.3.1... General................................................................................................................................................................................ 16

4.3.2... Monolithic instrument........................................................................................................................................................ 16

4.3.3... Monolithic instrument with external relevant data....................................................................................................... 17

4.3.4... Temperature recorder with digital probes..................................................................................................................... 18

4.3.5... Temperature recorder on the cloud............................................................................................................................... 20

5......... Requirements..................................................................................................................................................................... 21

5.1...... General................................................................................................................................................................................ 21

5.2...... Measuring range................................................................................................................................................................ 22

5.3...... Protection of the data from manipulation..................................................................................................................... 22

5.3.1... General................................................................................................................................................................................ 22

5.3.2... Audit trail.............................................................................................................................................................................. 22

5.3.3... Clearly readable data copies.......................................................................................................................................... 22

5.3.4... Safekeeping of accessibility of the data....................................................................................................................... 23

5.3.5... Safekeeping of readability of the data.......................................................................................................................... 23

5.3.6... Safekeeping of correctness of the data........................................................................................................................ 23

5.3.7... Access restrictions............................................................................................................................................................. 23

5.3.8... Detailed documentation of the software....................................................................................................................... 23

5.4...... Locking of settings............................................................................................................................................................. 23

5.5...... Recording............................................................................................................................................................................ 24

5.5.1... General................................................................................................................................................................................ 24

5.5.2... Traceability.......................................................................................................................................................................... 24

5.5.3... Chart only for mechanical recorder............................................................................................................................... 24

5.6...... Autonomous power supply.............................................................................................................................................. 24

5.7...... Degree of protection provided by the enclosure......................................................................................................... 25

5.8...... Electrical safety (if applicable)........................................................................................................................................ 25

5.9...... Operating characteristics linked to external
electrical influences.......................................................................................................................................................... 25

5.9.1... External supply voltage (if applicable).......................................................................................................................... 25

5.9.2... Autonomous supply (if applicable)................................................................................................................................ 26

5.9.3... Frequency (AC) (if applicable)........................................................................................................................................ 26

5.9.4... Power cut-offs.................................................................................................................................................................... 26

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5.9.5... Poruchy elektrického napětí a citlivost
na vyzařované elektromagnetické pole........................................................................................................................ 26

5.10.... Metrologické vlastnosti a charakter místa použití........................................................................................................ 26

5.10.1 Obecně................................................................................................................................................................................ 26

5.10.2 Metrologické vlastnosti..................................................................................................................................................... 26

5.10.3 Charakter místa použití..................................................................................................................................................... 27

5.11.... Bezpečnost dat................................................................................................................................................................... 28

5.12.... Úrovně ověřování softwaru.............................................................................................................................................. 28

6......... Zkušební metody............................................................................................................................................................... 29

6.1...... Přehled zkoušek................................................................................................................................................................ 29

6.2...... Obecné podmínky pro zkoušky....................................................................................................................................... 30

6.2.1... Justování před zkouškami............................................................................................................................................... 30

6.2.2... Standardní atmosférické podmínky............................................................................................................................... 30

6.2.3... Referenční podmínky........................................................................................................................................................ 31

6.3...... Stanovení chyby měření teploty...................................................................................................................................... 31

6.3.1... Zkušební metoda............................................................................................................................................................... 31

6.3.2... Čtení záznamu................................................................................................................................................................... 32

6.3.3... Uvádění výsledků.............................................................................................................................................................. 32

6.4...... Stanovení doby odezvy.................................................................................................................................................... 32

6.5...... Stanovení chyby doby záznamu..................................................................................................................................... 32

6.6...... Působení ovlivňujících veličin......................................................................................................................................... 33

6.6.1... Obecně................................................................................................................................................................................ 33

6.6.2... Kolísání napájecího napětí (je-li použitelné)................................................................................................................ 33

6.6.3... Vliv okolní teploty............................................................................................................................................................... 33

6.6.4... Zkoušení teploty za skladovacích a přepravních podmínek pro záznamové přístroje......................................... 34

6.6.5... Zkouška odolnosti proti nárazům (je-li použitelná)..................................................................................................... 35

6.6.6... Mechanické vibrace (je-li použitelná)............................................................................................................................ 35

6.6.7... Stupně ochrany krytem (Kód IP)..................................................................................................................................... 35

6.6.8... Elektrická bezpečnost (je-li použitelná)......................................................................................................................... 36

6.6.9... Dielektrická pevnost (je-li použitelná)............................................................................................................................ 36

6.7...... Zkouška softwaru............................................................................................................................................................... 36

6.7.1... Cíl zkoušky.......................................................................................................................................................................... 36

6.7.2... Zkušební postup................................................................................................................................................................. 36

7......... Přejímací podmínky.......................................................................................................................................................... 41

7.1...... Požadavky........................................................................................................................................................................... 41

7.2...... Limity provozní chyby....................................................................................................................................................... 41

8......... Značení................................................................................................................................................................................ 41

9......... Úvodní a pravidelná kalibrace........................................................................................................................................ 41

Příloha A (normativní) Zkoušení softwaru................................................................................................................................. 42

A.1...... Obecná část zkoušky softwaru – Cíl zkoušky............................................................................................................... 42

A.2...... Postup zkoušky.................................................................................................................................................................. 42

A.2.1.. Obecně................................................................................................................................................................................ 42

5.9.5... Electrical power disturbances and susceptibility
to radiated electromagnetic field.................................................................................................................................... 26

5.10.... Metrological characteristics and usage profiles.......................................................................................................... 26

5.10.1 General................................................................................................................................................................................ 26

5.10.2 Metrological characteristics............................................................................................................................................. 26

5.10.3 Usage profiles.................................................................................................................................................................... 27

5.11.... Data security....................................................................................................................................................................... 28

5.12.... Software verification levels.............................................................................................................................................. 28

6......... Test methods...................................................................................................................................................................... 29

6.1...... Test list................................................................................................................................................................................. 29

6.2...... General conditions for tests............................................................................................................................................. 30

6.2.1... Pre-tests adjustments....................................................................................................................................................... 30

6.2.2... Normal atmospheric conditions...................................................................................................................................... 30

6.2.3... Reference conditions........................................................................................................................................................ 31

6.3...... Determination of temperature measurement error.................................................................................................... 31

6.3.1... Test method........................................................................................................................................................................ 31

6.3.2... Reading the recording...................................................................................................................................................... 32

6.3.3... Expression of result........................................................................................................................................................... 32

6.4...... Determination of response time..................................................................................................................................... 32

6.5...... Determination of time recording error........................................................................................................................... 32

6.6...... Action of influence quantities.......................................................................................................................................... 33

6.6.1... General................................................................................................................................................................................ 33

6.6.2... Variation in voltage supply (if applicable)..................................................................................................................... 33

6.6.3... Influence of ambient temperature.................................................................................................................................. 33

6.6.4... Temperature testing under storage
and transport conditions for the recorder...................................................................................................................... 34

6.6.5... Shock resistance test (if applicable).............................................................................................................................. 35

6.6.6... Mechanical vibrations (if applicable)............................................................................................................................. 35

6.6.7... Degrees of protection provided by enclosures
(IP Code)............................................................................................................................................................................. 35

6.6.8... Electrical safety (if applicable)........................................................................................................................................ 36

6.6.9... Dielectric strength (if applicable).................................................................................................................................... 36

6.7...... Software test....................................................................................................................................................................... 36

6.7.1... Test objective...................................................................................................................................................................... 36

6.7.2... Test procedure................................................................................................................................................................... 36

7......... Conditions of acceptance................................................................................................................................................ 41

7.1...... Requirements..................................................................................................................................................................... 41

7.2...... Operating error limits........................................................................................................................................................ 41

8......... Marking................................................................................................................................................................................ 41

9......... Initial and periodic verification........................................................................................................................................ 41

Annex A (normative) Software testing....................................................................................................................................... 42

A.1...... Software test general part – Test objective................................................................................................................... 42

A.2...... Test procedure................................................................................................................................................................... 42

A.2.1.. General................................................................................................................................................................................ 42

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A.2.2.. Určení podjednotky zapisovacího zařízení teploty...................................................................................................... 42

A.2.3.. Určení relevantního softwaru každé jednotky
nebo podjednotky.............................................................................................................................................................. 42

A.2.4.. Definování použitelných zkušebních bloků
každé jednotky nebo podjednotky.................................................................................................................................. 43

A.2.5.. Určení typu každé jednotky nebo podjednotky............................................................................................................ 43

A.3...... Zkouška softwaru pro typ P1 a typ P2............................................................................................................................ 45

A.3.1.. Obecně................................................................................................................................................................................ 45

A.3.2.. Blok G: Základní požadavky............................................................................................................................................ 45

A.3.3.. Blok L: Specifické požadavky na software
pro dlouhodobé ukládání................................................................................................................................................. 56

A.3.4.. Blok T: Přenos naměřených dat přes
komunikační sítě................................................................................................................................................................ 64

A.3.5.. Blok S: Oddělení softwaru................................................................................................................................................ 70

A.3.6.. Blok D: Stažení relevantního softwaru........................................................................................................................... 74

A.4...... Softwarová zkouška pro typ P3....................................................................................................................................... 79

Příloha B (informativní) Zkušební formulář výrobce softwaru.............................................................................................. 81

B.1..... Identifikace.......................................................................................................................................................................... 81

B.1.1.. Identifikace výrobce.......................................................................................................................................................... 81

B.1.2.. Předmět zkoušky............................................................................................................................................................... 81

B.1.3.. Seznam dokumentů.......................................................................................................................................................... 81

B.1.4.. Definice aplikovatelných zkušebních bloků
každé jednotky nebo podjednotky (L, T, S a D)........................................................................................................... 82

B.1.5.. Výběr typu každé jednotky nebo podjednotky............................................................................................................. 83

B.2..... Zkušební požadavky pro typ P1 a typ P2...................................................................................................................... 84

B.2.1.. Obecně................................................................................................................................................................................ 84

B.2.2.. Základní požadavky.......................................................................................................................................................... 84

B.2.3.. Rozšíření L: Specifické požadavky na software
pro dlouhodobé ukládání................................................................................................................................................. 95

B.2.4.. Rozšíření T: Specifické požadavky na software
pro přenos dat.................................................................................................................................................................. 100

B.2.5.. Rozšíření S: Specifické softwarové požadavky
na oddělení softwaru...................................................................................................................................................... 105

B.2.6.. Rozšíření D: Specifické požadavky na software....................................................................................................... 108

B.3..... Požadavek na zkoušku pro typ P3............................................................................................................................... 112

Příloha C (informativní) Příklad formuláře s údaji popisujícími, zda je zařízení určité série
vhodné pro použití (k vyplnění výrobcem).................................................................................................................. 113

Příloha D (informativní) Předpokládaná doba provozu a kapacita ukládání................................................................... 115

D.1..... Kapacita ukládání závisí na intervalu měření............................................................................................................ 115

D.2..... Životnost baterie závisí na použití................................................................................................................................ 115

Příloha E (informativní) Požadovaný přístup k zaznamenaným datům nebo funkcím je uveden v tabulce E.1...... 116

A.2.2.. Determine the temperature recorder subunits............................................................................................................. 42

A.2.3.. Determine the relevant software of each unit
or subunit............................................................................................................................................................................. 42

A.2.4.. Define the applicable test blocks of each unit
or subunit............................................................................................................................................................................. 43

A.2.5.. Determine the type of each unit or subunit................................................................................................................... 43

A.3...... Software test for type P1 and type P2............................................................................................................................ 45

A.3.1.. General................................................................................................................................................................................ 45

A.3.2.. Block G: Basic requirements........................................................................................................................................... 45

A.3.3.. Block L: Specific software requirements
for long-term storage........................................................................................................................................................ 56

A.3.4.. Block T: Transmission of measurement data
via Communication Networks......................................................................................................................................... 64

A.3.5.. Block S: Software separation.......................................................................................................................................... 70

A.3.6.. Block D: Download of relevant software....................................................................................................................... 74

A.4...... Software test for type P3.................................................................................................................................................. 79

Annex B (informative) Manufacturer software test form........................................................................................................ 81

B.1..... Identification....................................................................................................................................................................... 81

B.1.1.. Manufacturer identification.............................................................................................................................................. 81

B.1.2.. Test object........................................................................................................................................................................... 81

B.1.3.. Documents list.................................................................................................................................................................... 81

B.1.4.. Define the applicable test blocks of each unit
or subunit (L, T, S and D).................................................................................................................................................. 82

B.1.5.. Selection of the type of each unit or subunit................................................................................................................ 83

B.2..... Test requirement for type P1 and P2............................................................................................................................. 84

B.2.1.. General................................................................................................................................................................................ 84

B.2.2.. Basic requirements........................................................................................................................................................... 84

B.2.3.. Extension L: Specific software requirements
for long term storage......................................................................................................................................................... 95

B.2.4.. Extension T: Specific software requirements
for data transmission...................................................................................................................................................... 100

B.2.5.. Extension S: Specific software requirements
for software separation.................................................................................................................................................. 105

B.2.6.. Extension D: Specific software requirements............................................................................................................ 108

B.3..... Test requirement for type P3......................................................................................................................................... 112

Annex C (informative) Example of data form describing suitability for use of equipment of a specific
series (to be filled in by the manufacturer)................................................................................................................. 11 3

Annex D (informative) Expected operation time
and storage capacity....................................................................................................................................................... 115

D.1..... Storage capacity dependent
on the measurement interval........................................................................................................................................ 115

D.2..... Battery lifetime dependent on usage.......................................................................................................................... 115

Annex E (informative) Required access to recorded
data or functions is given in Table E.1........................................................................................................................ 116

Evropská předmluva

European foreword

Tento dokument (EN 12830:2018) byl vypracován tech-
nickou komisí CEN/TC 423 Prostředky měření a/nebo zaznamenávání teploty v řetězci chlazení se sekretariátem v DIN.

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.

Této evropské normě je nutno nejpozději do února 2019 udělit status národní normy, a to buď vydáním identického textu, nebo schválením k přímému používání, a národní normy, které jsou s ní v rozporu, je nutno zrušit nejpozději do února 2019.

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.

Upozorňuje se na možnost, že některé prvky tohoto dokumentu mohou být předmětem patentových práv. CEN nelze činit odpovědným za identifikaci jakéhokoliv nebo všech patentových práv.

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.

Tento dokument nahrazuje EN 12830:1999.

This document supersedes EN 12830:1999.

Norma byla kompletně přepracována a aktualizována na úroveň znalostí následovně:

The standard has been completely revised and updated to the state of the art as follows:

–    Předmět normy byl rozšířen, tj. nově je zahrnuto umístění senzorů záznamníku s ohledem na způsob použití;

–    Scope was enlarged, i.e. location of sensors of the recorder with respect to types of usage are included now;

–    Aktualizace kapitoly 2 „Citované dokumenty“;

–    Update of Clause 2 “Normative references”;

–    Aktualizace kapitoly 3 “Termíny a definice“;

–    Update of Clause 3 “Terms and definitions”;

–    Byla doplněna kapitola 4 „Pojmy“;

–    Clause 4 “Concepts” was added;

–    Byla rozšířena kapitola 5 „Požadavky“ tj. byly doplněny články 5.3 „Ochrana údajů před manipulací“ a článek 5.12 „Úrovně ověření softwaru“ a dále byla aktualizována kapitola 5, např. hodnoty pro maximální relativní chybu načasování a dobu odezvy;

–    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;

–    Byl doplněn nový článek 6.7 „Zkouška softwaru“ a související příloha A „Zkoušení softwaru“ a příloha B „Formulář zkoušky softwaru výrobce“;

–    New subclause 6.7 “Software test” and the related Annex A “Software testing” and Annex B “Manufacturer software test form” were added;

–    Byla doplněna nová příloha D „Očekávaná doba provozu a kapacita uchovávání“ a příloha E „Požado-
vaný přístup k zaznamenaným datům nebo funkcím“.

–    New Annex D “Expected operation time and storage capacity” and Annex E “Required access to recorded data or functions” were added.

Tato evropská norma je dokumentem, který splňuje cíle směrnic:

This European Standard is a document meeting the objectives of Directives:

–    92/1/EHS ze dne 13. ledna 1992 o sledování teplot v dopravních prostředcích, uchovávání a skladování hluboce zmrazených potravin určených k lidské spotřebě;

–    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/EHS ze dne 14. června 1993 Rady pro hygienu potravin a zejména o „kritériích kontroly teploty“.

–    93/43/EEC of June 14, 1993 of the Council of the hygiene of foodstuffs and in particular on “temperature control criteria”.

Podle vnitřních předpisů CEN/CENELEC jsou tuto evropskou normu povinny zavést národní normalizační organizace následujících zemí: Belgie, Bulharska, Bývalé jugoslávské republiky Makedonie, České republiky, Dánska, Estonska, Finska, Francie, Chorvatska, Irska, Islandu, Itálie, Kypru, Litvy, Lotyšska, Lucemburska, Maďarska, Malty, Německa, Nizozemska, Norska, Polska, Portugalska, Rakouska, Rumunska, Řecka, Slovenska, Slovinska, Spojeného království, Srbska, Španělska, Švédska, Švýcarska a Turecka.

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.

1 Předmět normy

1 Scope

Tento dokument stanovuje technické a funkční vlastnosti záznamníků teploty použitých při přepravě, skladování a distribuci zboží, které je citlivé na teplotu, mezi –80 °C až +85 °C.

This document 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.

Specifikuje zkušební metody, které umožňují stanovit shodu daného zařízení s požadavky na použitelnost a provedení.

It specifies the test methods which allow the determination of the equipment's conformity, suitability and performance requirements.

Platí pro celý měřicí řetězec záznamníku teploty. Teplotní snímač(e) smí(ějí) být zabudován(y) do záznamového přístroje nebo smí(ějí) být od něho vzdálen(y) (vnější snímače).

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)].

Uvádí některé požadavky ve vztahu k umístění záznamového přístroje a jeho snímačů s ohledem na způsob použití jako přeprava, skladování a distribuce.

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.

POZNÁMKA Příklady pro přepravu, skladování a distribuci zboží citlivého na teplotu mezi –80 °C až +85 °C jsou chlazené, zmrazené a hluboce zmrazené a rychle zmrazené potraviny, zmrzlina, čerstvé a teplé potraviny, léčiva, krev, nebo orgány, chemikálie, biologické látky, elektronická a mechanická zařízení, květiny, rostliny, žárovky, suroviny a kapaliny, zvířata, umění a zařízení.

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.