Difference between revisions of "BTSMP1 EN12830"

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==EN12830==
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== 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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EN12830 is a European standard specifying the requirements and test methods for temperature recording devices used in the storage, transport, and distribution of chilled, frozen, deep-frozen, and quick-frozen food and other types of products. It ensures these devices meet specific accuracy, resolution, and response time criteria to maintain product safety and quality.
  
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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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==EYE SENSOR EN12830==
  
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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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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 this regulation: where? For whom? Why is it necessary?
 
  
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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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==Benefits of EN12830 Compliance==
  
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The text of the EN12830 standard gives an example of the fields of activity identified: “Examples of goods that are sensitive to transport, storage and distribution temperatures between -80 °C and +85 °C are refrigerated, frozen and deep-frozen goods, ice cream, fresh and hot food, pharmaceuticals, blood, organs, chemicals, biological materials, electronic and mechanical devices, flowers, plants, bulbs, raw materials and liquids, animals, works of art and furniture. »
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By adhering to the EN12830 standard, companies can ensure that their temperature recording devices are reliable and accurate, thereby maintaining the integrity of the cold chain and safeguarding the quality and safety of temperature-sensitive products. Main values:
  
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The scope of application is very broad, but we focus on 2 major branches of activity in terms of transport and logistics covered by this regulation:
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'''Ensures Food Safety''': By maintaining correct temperature conditions, the standard helps prevent the growth of harmful microorganisms and ensures the safety of food products.
  
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    Storage and transport of chilled, frozen and deep-frozen perishable goods.
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'''Quality Assurance''': Helps in maintaining the quality and shelf life of temperature-sensitive products.
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    Storage and transport of medical products: pharmaceuticals, blood products, organs and medical samples.
 
  
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Proprietary solution or open system?
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'''Regulatory Compliance''': Ensures that companies meet legal requirements, avoiding penalties and legal issues.
  
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There are many ways to deal with these security and integrity issues, but there are two main approaches:
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'''Traceability''': Provides reliable data for tracking and auditing the temperature history of products.
  
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    The first is to ensure the security and integrity of the data through a proprietary system. In short, from the sensor to the data visualization application level. In this case, compliance with the standard is easier to achieve because it is handled at the application level, which has significant computing resources. Nevertheless, this approach requires the exclusive use of the entire manufacturer’s solution: from the temperature sensor to the final application through all the manufacturer’s own communication layers.
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==Technical specification==
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    The second is to ensure data security and integrity through an open system. The temperature sensor itself is designed to meet the security and integrity requirements imposed by the standard. In this case compliance with the standard is more difficult to achieve, as it requires that this be handled at the sensor level, which has limited computing resources. However, this way of doing things allows manufacturers to remain open to any independent system, while ensuring compliance with the EN12830 standard.
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{| class="wikitable" style="width: 90%;"
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Resolution (°C)'''
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! style="width: 10%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Class (°C)'''
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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: 20%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Sensor temperature range'''
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! style="width: 20%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |'''Calibration temperatures'''
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" |0,01
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" | 0,5
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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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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" | -30°C, 5°C, and 70°C
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|}
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'''Resolution (°C) -''' Maximum resolution of change in temperature that the device can display.
  
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How do I know if a recorder complies with the EN12830 standard?
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'''Class (°C) -''' Specifies the maximum accuracy deviation of the temperature recording devices.
  
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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.
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'''Response time -''' The response time of a temperature sensor is the time it takes for the sensor to reach 90% of a step change in temperature. Typically, the maximum response time for air temperature sensors should be no more than 15 minutes. This ensures that the sensor can quickly detect changes in the air temperature, which is crucial for maintaining the correct storage or transport conditions.
  
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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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'''Sensor temperature range -''' Indicates operational temperature
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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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'''Calibration temperatures''' - The EYE SENSOR with EN12830 certification uses a sensor that has been factory calibrated in an ISO/IEC 17025 accredited laboratory. The temperatures listed in the table indicate the specific conditions at which the sensor was tested and calibrated.
  
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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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==Common temperatures to observe==
  
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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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The definition of the temperature values that you must respect depends on your sector of activity. To help you, if you are in the case of transport of perishable foodstuffs, the storage temperatures to be respected for various types of products:
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{| class="wikitable" style="width: 90%;
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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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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |Category
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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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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Product Type
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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.
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Common Temperature Range
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! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Examples
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What temperature values must you observe?
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|-
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| rowspan="5" ! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Food and Beverages
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The definition of the temperature values that you must respect depends on your sector of activity. To help you, if you are in the case of transport of perishable foodstuffs, the Ministry of Agriculture publishes a summary table of storage temperatures to be respected. You can download this documentation here.
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Fresh Produce
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;" |0°C to 10°C (32°F to 50°F)
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Here is an excerpt from the document:<br>
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Fruits, vegetables
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|-
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[[File:Cold chain EN12830 and EN13486 standards all you need to know.png|thumb|left]]
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Dairy Products
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|1°C to 4°C (34°F to 39°F)
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For the transport of pharmaceuticals, blood and samples the 3 most frequently used temperature values are as follows:
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Milk, cheese, yogurt
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|-
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* 20°C (range 18 to 24°C)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Meat and Poultry
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* 4°C (range 2 to 8°C)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|0°C to 4°C (32°F to 39°F)
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* – 20°C (range-30 to – 18°C).
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Fresh meat, poultry
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|-
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It is quite frequent in this sector of activity that the recorders are certified for all 3 temperature values simultaneously, which inevitably increases the cost of certification. Attention, this is given for information only and it is important to check the requirements of your sector of activity.
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Frozen Foods
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What temperature accuracy do you have to respect?
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"| -18°C to -20°C (-0.4°F to -4°F)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Frozen vegetables, meats, ice  cream
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The definition of the temperature accuracy you need to meet depends on your industry and your requirements. For example for the transport of perishable goods your recorder must be accurate to + or – 2°C. It must therefore be class 2 or better (Class 1 for example).
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Chilled Beverages
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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.
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|2°C to 10°C (36°F to 50°F)
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Soft drinks, beer
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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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|-
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How often should you have your recorder checked?
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| rowspan="3" ! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Pharmaceuticals  and Medical
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Refrigerated Pharmaceuticals
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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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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|2°C to 8°C (36°F to 46°F)
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How do you know if your recorder complies with the EN13486 standard?
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Vaccines, insulin
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|-
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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.
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Frozen Pharmaceuticals
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"| -20°C to -10°C (-4°F to 14°F)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Certain biological samples,  specific medications
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Controlled Room Temperature (CRT) Pharmaceuticals
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|15°C to 25°C (59°F to 77°F)
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Most oral medications,  over-the-counter drugs
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|-
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| rowspan="2" ! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Chemicals  and Industrial
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|General Chemicals
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|15°C to 25°C (59°F to 77°F)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Solvents, reagents
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Temperature-Sensitive Chemicals
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|2°C to 8°C (36°F to 46°F) or below
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Certain catalysts, lab reagents
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|-
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| rowspan="2" ! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;"|Electronics
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Electronic Components
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|15°C to 25°C (59°F to 77°F)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Circuit boards, semiconductors
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Temperature-Sensitive Electronics
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Varies, often lower temperatures
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Some battery types, high-precision  instruments
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|-
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| rowspan="2" ! style="width: 15%; border: 1px solid white; border-bottom: 2px solid #0054A6; background: white; color: #0054A6; text-align: center;" |Other  Products
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Cosmetics
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|15°C to 25°C (59°F to 77°F)
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| style="border: 1px solid white; border-bottom: 2px solid #E8E8E8; text-align: center; vertical-align: center; background: white;"|Creams, lotions, makeup
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|-
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Artwork and Archival Materials
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|18°C to 22°C (64°F to 72°F) with controlled humidity
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| style="border: 1px solid white; border-bottom: 2px solid #0054A6; text-align: center; vertical-align: center; background: white;"|Paintings, manuscripts
 +
|}
  
 
==Attachments==
 
==Attachments==
 +
Certificate of Type Conformity to the standards NF EN 12830 (August 2018)
 
{|style="margin: 0 auto;valign="left""
 
{|style="margin: 0 auto;valign="left""
 
| [[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]]'''.

Latest revision as of 17:38, 10 June 2024

EN12830

EN12830 is a European standard specifying the requirements and test methods for temperature recording devices used in the storage, transport, and distribution of chilled, frozen, deep-frozen, and quick-frozen food and other types of products. It ensures these devices meet specific accuracy, resolution, and response time criteria to maintain product safety and quality.

EYE SENSOR EN12830

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.

Benefits of EN12830 Compliance

By adhering to the EN12830 standard, companies can ensure that their temperature recording devices are reliable and accurate, thereby maintaining the integrity of the cold chain and safeguarding the quality and safety of temperature-sensitive products. Main values:

Ensures Food Safety: By maintaining correct temperature conditions, the standard helps prevent the growth of harmful microorganisms and ensures the safety of food products.

Quality Assurance: Helps in maintaining the quality and shelf life of temperature-sensitive products.

Regulatory Compliance: Ensures that companies meet legal requirements, avoiding penalties and legal issues.

Traceability: Provides reliable data for tracking and auditing the temperature history of products.

Technical specification

Resolution (°C) Class (°C) Response time Sensor temperature range Calibration temperatures
0,01 0,5 13 min from -20 °C to +60 °C -30°C, 5°C, and 70°C

Resolution (°C) - Maximum resolution of change in temperature that the device can display.

Class (°C) - Specifies the maximum accuracy deviation of the temperature recording devices.

Response time - The response time of a temperature sensor is the time it takes for the sensor to reach 90% of a step change in temperature. Typically, the maximum response time for air temperature sensors should be no more than 15 minutes. This ensures that the sensor can quickly detect changes in the air temperature, which is crucial for maintaining the correct storage or transport conditions.

Sensor temperature range - Indicates operational temperature

Calibration temperatures - The EYE SENSOR with EN12830 certification uses a sensor that has been factory calibrated in an ISO/IEC 17025 accredited laboratory. The temperatures listed in the table indicate the specific conditions at which the sensor was tested and calibrated.

Common temperatures to observe

The definition of the temperature values that you must respect depends on your sector of activity. To help you, if you are in the case of transport of perishable foodstuffs, the storage temperatures to be respected for various types of products:

Category Product Type Common Temperature Range Examples
Food and Beverages Fresh Produce 0°C to 10°C (32°F to 50°F) Fruits, vegetables
Dairy Products 1°C to 4°C (34°F to 39°F) Milk, cheese, yogurt
Meat and Poultry 0°C to 4°C (32°F to 39°F) Fresh meat, poultry
Frozen Foods -18°C to -20°C (-0.4°F to -4°F) Frozen vegetables, meats, ice cream
Chilled Beverages 2°C to 10°C (36°F to 50°F) Soft drinks, beer
Pharmaceuticals and Medical Refrigerated Pharmaceuticals 2°C to 8°C (36°F to 46°F) Vaccines, insulin
Frozen Pharmaceuticals -20°C to -10°C (-4°F to 14°F) Certain biological samples, specific medications
Controlled Room Temperature (CRT) Pharmaceuticals 15°C to 25°C (59°F to 77°F) Most oral medications, over-the-counter drugs
Chemicals and Industrial General Chemicals 15°C to 25°C (59°F to 77°F) Solvents, reagents
Temperature-Sensitive Chemicals 2°C to 8°C (36°F to 46°F) or below Certain catalysts, lab reagents
Electronics Electronic Components 15°C to 25°C (59°F to 77°F) Circuit boards, semiconductors
Temperature-Sensitive Electronics Varies, often lower temperatures Some battery types, high-precision instruments
Other Products Cosmetics 15°C to 25°C (59°F to 77°F) Creams, lotions, makeup
Artwork and Archival Materials 18°C to 22°C (64°F to 72°F) with controlled humidity Paintings, manuscripts

Attachments

Certificate of Type Conformity to the standards NF EN 12830 (August 2018)

You can the find PDF version of the EN12830 Certification here.

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