In this article, we will briefly describe the specifications required by the DIN 58345 standard for the proper storage of heat-sensitive products—that is, medications, vaccines, and biological samples that must be stored within a specific temperature range (between 2° and 8°C).
As you would expect, at Coreco, all of our refrigerators comply with these regulations to ensure that our entire medical product line meets very high quality standards.
What is DIN 58345?
DIN stands for «Deutsches Institut für Normung» (German Institute for Standardization).
The DIN 58345 standard applies to medical-grade refrigerators used to store heat-sensitive products at an operating temperature of 2°C to 8°C.
10 requirements of the DIN 58345 standard
The DIN standard can be summarized as 10 requirements that a pharmaceutical refrigerator must meet.
Following these 10 guidelines ensures effective storage.
Furthermore, the DIN standard is intended not only to ensure the proper storage of medications that require refrigeration, but also to ensure that medications are protected against unauthorized access and that occupational health and safety guidelines regarding noise protection are followed.
1. Operating Temperature
According to DIN 58345, the operating temperature of a medication refrigerator must be between a minimum of +2°C and a maximum of +8°C. This ensures that the medications and vaccines stored in the refrigerator do not freeze or become too warm.
2. Room temperature
Medication refrigerators that comply with DIN 58345 must maintain a constant internal temperature of +2°C to +8°C at ambient temperatures of +10°C to +35°C. This temperature range corresponds to the ambient temperature that must be assumed.
This temperature range corresponds to the minimum or maximum ambient temperature that should be assumed for most of Europe.
3. Noise Emissions
According to DIN 58345, the noise level of a pharmaceutical refrigerator must be less than 60 dB. This specification helps keep noise levels in the work environments of pharmacies, hospitals, and doctors' offices as low as possible.
4. Visual and audible alarm for temperature deviations
To ensure that action is taken as quickly as possible when the specified indoor temperatures are exceeded or not reached, DIN 58345 stipulates that a visual and audible alarm must be activated in the event of temperature deviations.
5. Visual and audible alarm in the event of a power failure
The DIN 58345 standard stipulates that a pharmaceutical refrigerator must use a visual and audible warning signal to alert users to a power failure. This power failure alarm must remain active for at least 12 hours.
6. Preparing to Record the Operating Temperature
In order to demonstrate that the medications and vaccines stored in the medication refrigerator have been properly preserved at all times, the DIN standard stipulates that the refrigerator must be capable of recording internal temperatures.
7. Safety Thermostat
To ensure that the internal temperature never drops below +2°C—which would cause freezing and, consequently, the destruction of the stored medications, a medication refrigerator compliant with DIN 58345 must be equipped with a safety thermostat to prevent minimum temperatures.
8. Mechanical load-bearing capacity of the components
According to DIN 58345, the built-in components of pharmaceutical refrigerators (drawers and shelves) must have a load-bearing capacity of at least 100 kg/m². The high load-bearing capacity ensures that the built-in components do not collapse even when loaded with infusion solutions or other heavy containers.
9. Door with a lock
Many medications are not only valuable but also dangerous in the wrong hands. For safety reasons, medication refrigerators must be equipped with a lockable door in accordance with the DIN standard. The key should be accessible only to authorized specialized personnel.
10. Remote maintenance capability
In hospitals in particular, medication refrigerators are typically monitored via remote maintenance so that staff can respond immediately to power outages or temperature deviations. According to DIN 58345, refrigerators must be equipped with a potential-free contact that enables this remote maintenance.
Purpose of the regulation
Many medications simply need to be stored in a cool place to remain effective. These include, for example, various eye drops, several metered-dose inhalers, and many biopharmaceutical products, such as certain types of vaccines, insulin, and interferons.
However, there is another type of compound—thermolabile compounds—that requires more precise temperature ranges. To ensure compliance with the storage specifications for this type of product, which does require refrigeration, the DIN 58345 standard was established. .
What does the standard specify?
This standard applies to refrigerators for thermolabile substances, which are equipped with a cooling device and are used to store these substances at an operating temperature of 2 °C to 8 °C.
If you need more information, you can refer to the report prepared by the NA 063-02-06 AA Work Committee «NAMed's Refrigerators and Freezers for Medications» in Germany.
To whom does the DIN 58345 standard apply?
- Medical Appointments
- Health Centers
- Hospitals
- Pharmacies
Summary of Requirements
- Operating temperature: +2°C to +8°C
- Operating temperature: +10°C to +35°C
- Noise emissions: < 60 dB(A)
- Visual and Audible Warning System for High and Low Temperatures
- Dry contact for external alarm systems
- Active alert system that activates after a minimum of 12 hours in the event of a power outage
- Safety thermostat to prevent temperatures from falling below +2°C
- Load-bearing capacity of at least 100 kg/m²
- Door with a lock
Coreco: More Than Just a Good Medical Refrigerator
At Coreco, we are committed to quality and well-made refrigerators. This is confirmed by our compliance with all essential quality standards for our processes.
At this link, you'll find not only this one but also all quality certifications that our devices have.
If you'd like to learn more about our MedicalLab product line, please feel free to Request our catalog.
