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→EN12830
In this article, we propose a focus on these 2 standards, their scope of application and the legal obligations resulting from them.
In this article, we propose a focus on these 2 standards, their scope of application and the legal obligations resulting from them.
Scope of this regulation: where? For whom? Why is it necessary?
==Scope of this regulation: where? For whom? Why is it necessary?==
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.
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.
Proprietary solution or open system?
==Proprietary solution or open system?==
There are many ways to deal with these security and integrity issues, but there are two main approaches:
There are many ways to deal with these security and integrity issues, but there are two main approaches:
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.
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.
How do I know if a recorder complies with the EN12830 standard?
==How do I know if a recorder complies with the EN12830 standard?==
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.
You need to define the accuracy class for which you want the periodic verification. This class is related to your industry.
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?==
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.
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.