SIST EN 12830:2018

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

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

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

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
— 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

« 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

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

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 reconstructs and examines the sequence of activities surrounding or leading to a specific operation, procedure, or event in a security relevant transaction from inception to final result Note 1 to entry: See National Information Assurance (IA) Glossary. Committee on National Security Systems. 7 August 1996. p. 4). It documents who did what and when. 3.35 service provider organization or business which offers service to others in exchange for payment 3.36 relevant measurement data set of temperature—time—location tuples recorded during the traceability time span Note 1 to entry: Once data age exceeds this time span it loses its “relevant” status. 3.37 relevant parameters parameters that affect relevant measurement data
EXAMPLE Calibration parameters, time-date settings and installation location (such as truck ID or warehouse room ID). 3.38 relevant software software that produces, stores, process or transmits relevant data Note 1 to entry: Relevant software can cohabit with non-relevant software. 3.39 command any physical or logical system that enables the access to a function SIST EN 12830:2018

A measuring system can consist of one measuring instrument. 4 Concepts 4.1 General The objective of the temperature recorder is to generate and to record at least the accurate temperature and time, and the accurate location if applicable. An additional concept is the time span that the recorded data has to be traceable (for example, minimum one year for deep frozen food.) The recorder can be a fully mechanical recorder, a mechanical and electronic recorder or a fully electronic recorder. This is why “relevant software” is not always present. Relevant measurement data can be exported for its exploitation by other systems, for example a fleet or warehouse management system. If the exporting mechanism cannot guarantee the traceability of the data, the exported data loses its “relevant” status. The instrument will normally include a set of parameters that affect relevant characteristics of the temperature recorder. For example, calibration parameters, time-date settings and installation location (such as truck ID or warehouse room ID). We will call these parameters “relevant parameters”. The combination of the relevant measurement data plus the relevant parameters forms the “relevant data”. The software that produces, stores, process or transmits relevant data are called reporting software. Relevant software can cohabit with non-relevant software. SIST EN 12830:2018

Figure 1 — Abstract view of the temperature recorder showing its main elements Temperature sensor type can be PT100, PT1000, NTC, Thermocouple, etc. Sensor can be internal, when they are located within the unit enclosure, or external, when not. External sensors can be changeable or fixed to the unit. Sensor intended to measure the temperature of air or the core temperature of the product (insertion sensor). External sensors can be packaged as digital probes when they include electronics to convert the temperature to a numeric value and to communicate with the recorder through a digital channel. Power supply can be external or internal. Internal supply types can be rechargeable and non-rechargeable. An output mechanism will provide output data. Common alternatives are display, printer, and communication port. Communication port can be wire connected or wireless, and can follow an approved standard or be of proprietary design. An input mechanism is used to give commands to the temperature recorder. Common alternatives are keyboard, touchscreen and communication port. The clock for electronic recorder is commonly based on a crystal oscillator that produces a very precise frequency. In order to maintain the correct time on power off, a backup power source is required to keep the clock running. Temperature recorder memory can be volatile or non-volatile. The non-volatile memory can be erasable or permanent. When the temperature recorder program is stored in permanent memory the unit is non-reprogrammable. When the measurements are stored in volatile memory a backup power source is required to ensure that relevant data are not lost on power off. 4.3 Temperature recorder architecture (or configuration) 4.3.1 General The temperature recorder can be built in a variety of architectures ranging from a monolithic instrument to a very complex distributed system. All the subunits of a distributed system that generates, encodes, transports, or stores relevant data will form part of the temperature recorder. In order to clarify the boundaries of the temperature recorders, a description of the possible alternatives and major design challenges will be given in 4.3.2 to 4.3.5. SIST EN 12830:2018

Figure 2 — Monolithic temperature recorder 4.3.3 Monolithic instrument with external relevant data As shown in Figure 3, in this alternative the relevant data can be kept in an external medium. Relevant data are exported to an external device and can be erased from the temperature recorder. In many cases the external device will be a computer that will store in its disk the exported relevant data. The exported relevant data are packaged in such a way as to prevent and/or detect its manipulation. The packaging could be performed internally by the instrument or externally by a computer. In the first case, the downloading to the external storage can be done by an off the shelf application. In the second case, the data leaves the instrument in clear (that is without packaging) and is externally packaged. Therefore, the downloading and packaging application is instrumental to the traceability of the data, and is considered a subunit of the temperature recorder. The connection between the instrument and the external storage can be by wired or wireless. Note that the user of the temperature recorder has the responsibility of maintaining the exported relevant data, for example, implementing a sound backup policy. SIST EN 12830:2018

Figure 3 — Monolithic instrument with external storage of relevant data In addition to the challenges defined for monolithic instruments, this architecture presents the following challenges: — Design a data packaging that prevents and/or detects its manipulation; — Design a packaging mechanism that guaranties authenticity; — Design a communication mechanism that avoids data loss. 4.3.4 Temperature recorder with digital probes A digital probe includes a temperature sensor as well as a signal conditioner which produces a numerical temperature value. As is depicted in Figure 4, the digital probes are connected to a base unit. The temperature recorder is a measurement system composed of the base station and the digital probes. Digital probes can be simple, responding with the current temperature to a base command. Alternatively, the digital probe could also include a clock and a memory to store relevant data, implementing a protocol to transmit the relevant data when appropriate. In this architecture the temperature recorder is a measurement system composed of two subunits: the base station and the digital probe.
Figure 4 — Temperature recorder with digital probes The connection of the digital probes with the base station can be made via a cable or via a wireless digital link. Wireless digital probes normally will include some storage capacity to avoid loss of data in case of link temporal failure. Physical probe sealing is limited to wire connected probes, whereas virtual or software seals will support both wire and wireless connections. Figure 5 shows that auxiliary communication components, such as routers, repeaters or switches, can be included to extend the range of the base stations both in distance and in number of probes. SIST EN 12830:2018

Figure 5 — Temperature recording system with wire and wireless connections 4.3.5 Temperature recorder on the cloud An extension of 4.3.2 consists of using the cloud as the external storage medium. In that case, as Figure 6 shows, the temperature recorder system includes the transmission, processing and storage of the relevant data in the cloud. If the data are packaged before it is sent to the cloud, transmission and storage of the encoded relevant data can be done with off the shelf applications. If that is not the case, the transmission and packaging application is instrumental to the traceability of the data, and is considered a subunit of the temperature recorder system. There are two fundamentally different design options for the cloud server. The first is an owner hosted system and the second is the Solution as a Service (SaaS) approach. a) Owner hosted system: The cloud server and database are stored, managed and maintained by the organization owner of the temperature recorders, which is also responsible for maintaining the cloud system and ensuring its correct performance. b) Solution as a Service (SaaS): The monitoring system hardware (sensors, recorders and base stations) is installed at the organization site, but the software, server and database are hosted by a service provider. The data are collected, stored and managed by the service provider whilst the organization owner of the recorders has access to the data through a secure web interface or other remote procedure. In this scenario, the service provider ensures the cloud system maintenance, correct performance and qualification. This solution includes all the challenges described on the previous sections. Additionally, this architecture presents the following challenge: Dimensioning, maintenance and operation of the cloud system. SIST EN 12830:2018

Figure 6 — Two temperature recorders with relevant data in the cloud 5 Requirements 5.1 General The means of temperature measurement used by the recorder shall be independent of any temperature measurement which is used to control the refrigerating system. Manufacturers shall make recommendations on the specification of ancillary equipment in order to meet the performance requirements of this European Standard. The manufacturer shall define the use of the transport, storage and operational conditions. Examples are given in the informative Annexes C and D. NOTE Further information is included in EN 60721-3-3 and EN 60721-2-3. The manufacturer shall verify the defined requirements of his applications. The system shall have the possibilities to prevent and/or detect manipulation and to prove the validity of the data; The system shall have the possibility to log changes in the parameters that influence the relevant data for example: a) measurement value; b) time stamp; c) correlation between measurement value and time stamp; d) settings: 1) measurement interval; 2) measurement limits; SIST EN 12830:2018

kept at least as long as the data itself . 5.2 Measuring range — The temperature recorder shall be able to measure in the measuring range that it is defined by the manufacturer. — For climate classes see the relevant legislation and quality specifications. 5.3 Protection of the data from manipulation 5.3.1 General The software shall prevent and/or at least detect both intended and not intended manipulation of the relevant data. This is true for all relevant data as long as they are managed by the measurement system, including during storage and transmission. 5.3.2 Audit trail The software of the measurement can have an audit trail. 5.3.3 Clearly readable data copies The software shall be able to present the relevant data in a way that is directly readable by persons or authorities in an easy way. 5.3.4 Safekeeping of accessibility of the data The software shall have a possibility to make sure the user can access the relevant data any time, provided he/she has the rights to do so (see access restrictions 5.3.7). — the data readability at the temperature logger shall be provided as a minimum requirement over an interface (USB, wireless, etc.), for example as pdf-file or in another digital format; or — an access shall be provided directly at the display of the device at any time to display the actual recorded temperature by an (PIN) entry code in case of it's not directly accessible; or — a printout of the data on an internal printer shall be provided for devices without an internal display i.e. at devices like telematic systems; or — an access shall be provided by a software ap
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