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BTSMP1 EN12830 (view source)

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==EN12830==
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==EYE SENSOR EN12830==
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The control and monitoring of temperatures throughout the cold chain are very important issues with regard to the quality of goods. In order to ensure that food products and products from the pharmaceutical industry are kept at adequate temperatures and that these temperatures are recorded for continuous control purposes, a number of standards must be met.
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European regulations require, among other things, the use of recorders that comply with the regulations, which must be regularly checked (Learn more about sensor calibration). These two aspects related to the traceability of the cold chain are the subject of standards called respectively EN12830 for the recorders and EN13486 for their verification.
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In this article, we propose a focus on these 2 standards, their scope of application and the legal obligations resulting from them.
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Effective control and monitoring of temperatures within the cold chain are crucial for maintaining the quality of goods. To guarantee optimal temperature conditions for food and pharmaceutical products and to ensure continuous monitoring, adherence to a set of standards must be met. European regulations require, among other things, the use of recorders that comply with the of standard called EN12830.
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==Scope of this regulation: where? For whom? Why is it necessary?==
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EYE Sensor EN12830 is a Bluetooth® Low Energy recorder that enhances business operations through certified temperature monitoring. This sensor holds an EN12830 certificate and delivers precise measurements with a 0.5°C accuracy class across all working ranges from -20°C to +60°C. Each temperature sensor is calibrated in an ISO 17025-certified laboratory to ensure reliability. Designed with a food-grade casing that complies with EU and FDA regulations for food contact applications, the EYE Sensor EN12830 is perfect for tracking perishables like dairy, meat, and pharmaceuticals. It also features internal memory capable of storing temperature readings for up to 345 days, ensuring compliant monitoring.
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==Scope of regulation==
    
In a context of globalization, the storage, transport and distribution of heat-sensitive products are subject to different regulations depending on the country. This article will only deal with the subject of regulations on the European territory. There are many professions that have to comply with the regulations on cold chain traceability and you must make sure of the standards applicable to your branch of activity.
 
In a context of globalization, the storage, transport and distribution of heat-sensitive products are subject to different regulations depending on the country. This article will only deal with the subject of regulations on the European territory. There are many professions that have to comply with the regulations on cold chain traceability and you must make sure of the standards applicable to your branch of activity.
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     Storage and transport of chilled, frozen and deep-frozen perishable goods.
 
     Storage and transport of chilled, frozen and deep-frozen perishable goods.
 
     Storage and transport of medical products: pharmaceuticals, blood products, organs and medical samples.
 
     Storage and transport of medical products: pharmaceuticals, blood products, organs and medical samples.
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==Technical information==  
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==Technical information==
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{| class="wikitable" style="width: 80%;"
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Resolution'''
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''class'''
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Response time'''
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Sensor temperature range'''
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" |0,01 °C
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" | 0,5 °C
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" | 13 min
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" | from -20 °C to +60 °C
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|}
    
==Proprietary solution or open system?==
 
==Proprietary solution or open system?==
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The manufacturer of your recorder must be able to issue a certificate of conformity in its own name. Furthermore, this equipment must have undergone conformity tests carried out by a COFRAC-accredited standardization laboratory. The manufacturer must be able to provide you with the test report from this COFRAC-accredited laboratory. Attention, it is your responsibility to check that the report refers to the standard in force: in this case the 2018 version of EN12830.
 
The manufacturer of your recorder must be able to issue a certificate of conformity in its own name. Furthermore, this equipment must have undergone conformity tests carried out by a COFRAC-accredited standardization laboratory. The manufacturer must be able to provide you with the test report from this COFRAC-accredited laboratory. Attention, it is your responsibility to check that the report refers to the standard in force: in this case the 2018 version of EN12830.
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Moreover, in France, the Ministry of Agriculture regularly publishes the list of compliant temperature recorders, which can be consulted here. However, this list does not give any information on the version of the standard used for the declaration of conformity: 1999 or 2018.
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EN13486: verification of the recorder accuracy
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Compliance with the EN12830 standard is unfortunately not sufficient. You must also comply with the EN13486 standard! Attention, the current revision of the EN13486 standard dates from 2002 and a CEN technical committee has launched the revision of this standard NF EN 13486.
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It is well known that sensors have the unfortunate tendency to drift over time, i.e. the measurement they give can become progressively less accurate after a few years. This is true for all sensors and also for temperature sensors. This is why periodic inspections have been imposed and you must comply with them.
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The periodic verification of the recorders is the responsibility of its user, i.e. the carrier and the logistician. Nevertheless, there are some rules to know to organize a certification campaign to EN13486 :
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    This periodic verification must be done by a COFRAC (Le Comité Français d’Accréditation) accredited body for France. The laboratory you have chosen must be able to give you its “accreditation certificate” issued by COFRAC with these validity dates.
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    You must define the reference temperature(s) for which you want to obtain the periodic verification. Be careful, the cost of certification is often proportional to the number of temperature values to be verified.
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    You need to define the accuracy class for which you want the periodic verification. This class is related to your industry.
      
==What temperature values must you observe?==
 
==What temperature values must you observe?==
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[[File:Cold chain EN12830 and EN13486 standards all you need to know.png|thumb|left]]
 
[[File:Cold chain EN12830 and EN13486 standards all you need to know.png|thumb|left]]
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For the transport of pharmaceuticals, blood and samples the 3 most frequently used temperature values are as follows:
 
For the transport of pharmaceuticals, blood and samples the 3 most frequently used temperature values are as follows:
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Concerning the transport of pharmaceutical and blood products the recorder temperature class requested and frequently class 1 (+ or – 1°C accuracy) in the negative temperature ranges and class 0.5 (+ or – 0.5°C accuracy) in the positive ranges.
 
Concerning the transport of pharmaceutical and blood products the recorder temperature class requested and frequently class 1 (+ or – 1°C accuracy) in the negative temperature ranges and class 0.5 (+ or – 0.5°C accuracy) in the positive ranges.
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Be careful, it is up to you to define the class you wish to verify and the cost of the certification is all the higher the more precise the requested class is.
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How often should you have your recorder checked?
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The text of the standard states that “the frequency of testing depends on the requirements of the user, taking into account the manufacturer’s specifications”. Nevertheless, it gives some recommendations: “It is recommended, however, that the manufacturer or workshops authorized by the manufacturer or the approved verification services carry out an inspection each year, when the temperature recorders and thermometers have been used during this period. »
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How do you know if your recorder complies with the EN13486 standard?
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The laboratory that performed the periodic verification shall be able to provide a verification report or calibration report for each recorder or sensor with the date of the report. In addition, the recorder itself shall be visibly marked with the fact that it has been verified and the date of verification.
      
==Attachments==
 
==Attachments==
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| [[File:BTSMP1_EN12830_certificate_p1_1.png|thumb|x300px|alt=|none]]
 
| [[File:BTSMP1_EN12830_certificate_p1_1.png|thumb|x300px|alt=|none]]
 
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You can the find PDF version of the EN12830 Certification'''[[Media:BTSMP1_EN12830_Certificate.pdf | here]]'''.
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You can the find PDF version of the EN12830 Certification'''[[Media:BTSMP1 EN12830 Certificate.pdf| here]]'''.
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