Certification for Medical Refrigerators & Freezers

Part
01
of two
Part
01

US Refrigerator and Freezer Requirements

The regulatory requirements for commercial refrigerators and freezers in the USA have been summarized into 3 categories: Certification requirements for both medical and non-medical, energy star requirements for both medical and non-medical, vaccine storage requirements and walk-in unit requirements. Below you will find a deep-dive of our research.

Certification requirements for medical and non-medical refrigerators and freezers

According to Code of Federal Regulations, Section 429.42, below is a summary of the requirements for commercial refrigerators and freezers. The CFR does not provide a separate guideline for medical and non-medical equipment. The detailed requirements can be found here.

1. The represented value, which encompasses certified ratings must be determined by either unit testing or by Alternative Efficiency Determination Method (AEDM).
In case of unit testing, the represented value of the sample size for energy consumption should be greater than or equal to the higher of the mean of the sample or the Upper Confidence Limit (UCL) where the confidence level is 95% and the mean is divided by 1.10. Apart from this, the represented value for the equipment in which the consumers prefer high values should be less than or equal to the lower of the mean of the sample or the Lower Confidence Limit (UCL) where the confidence level is 95% and the mean is divided by 0.90.
In case of AEDM, the represented value of energy consumption, where the consumers prefer lower values, should be greater than or equal to the AEDM output and less than or equal to the Federal Standard of the model. For ratings where the consumers prefer higher values, the represented value of energy consumption should be less than or equal to the AEDM output and greater than or equal to the federal standard of the model.

2. The certification reports must include information such as daily energy consumption, rating temperature, compartment volume and adjusted volume, display area if the model was engineered-to-order and other AEDM related details which can be found here. Along with this, a supplement in PDF format for any additional testing and special features etc related information must also be included. These guidelines for the certification reports are in specific to the commercial refrigeration equipment. The general requirements included in section 429.12 of the CFR, which can be seen here, apply to this category as a default.

Energy Star requirements for medical and non-medical refrigerators and freezerS

In order to acquire an 'Energy Star' certification, the equipment must qualify for the certification in the Maximum Daily Energy Consumption (MDCE) limits, which are listed here in a table on page 7. The testing to get the equipment certified can be performed by either testing a single unit, the MDCE for which should be equal to or better than the limits given by Energy Star or using the methodology described in the certification requirements as discussed in the previous section. The energy rating if the latter method is used should also be equal to or better than the limits given by Energy Star. In addition to these, the test methods outlined in 431 Sub Part C which gives tabulated specification for Daily Energy Consumption (DEC) under section 431.66 should be adhered to.

vaccine storage requirements

In order to store vaccines, some of the requirements mentioned by the CDC (Center for Disease Control and Prevention) are
1. The storage units must be able to accommodate a year's highest inventory without it being crowded. Also, the storage unit must be able to store water bottles in the refrigeration and freezer sections adequately to maintain the stability and potency of the vaccines being stored.
2. A calibrated thermometer must be set-up in the equipment to show the temperature of the unit. Also, the unit must be able to main consistent temperatures without fluctuations. The unit must also not be used to store foods.
3. Bar styled, dorm styled and household styled units must not be used as vaccine storage.

walk-in unit requirements

The energy efficiency requirements for walk-in units can be done using multiple ways:
1. By determining the U-factor, conduction load and energy use
All these values, irrespective of the method used should be compliant with the AHRI which can be found here.

Other than the requirements mentioned above, in cases where commercial refrigerators and/or freezers store food meant for human consumption, the following requirements are specified by CFR: The equipment must be designed so that contamination with fuel, lubricants, coolants and other toxic materials does not occur, should be made of non-toxic materials, should be able to withstand environments in which they are installed, should be fitted with automated alarm and temperature regulation systems and other requirements specified here.

We were unable to find anything different from the current set of regulations that are used are general standards for commercial refrigerators and/or freezers.

CONCLUSION

To wrap it up, most of the regulations that apply to the commercial refrigerators and/or freezers are governed by CFR. These regulations are not designed separately for medical and non-medical equipment. Although a separate set of requirements is mentioned by CDC for vaccine storage. Requirements are also given separately for commercial refrigerators and/or freezers that will store foods meant for human consumption.
Part
02
of two
Part
02

Canada Refrigerator and Freezer Requirements

Overview
Canada has specific regulations that govern the sale of freezers and refrigerators for medical and no medical use. That these regulations govern sales can be deduced from the fact that they are stipulated to limit import from borders and they carry penalties for non-compliance. The regulations are primarily contained in the Energy Efficiency Act which stipulates that these appliances carry the EnerGuide Label. These requirements are a matter of law and persons who do not comply with them can be summarily convicted and pay a fine not more than $50,000 or be indicted and also pay a fine not more than $200,000. Please find below a more detailed account of our finding including mandatory requirements for sale for medical and non-medical use.
Mandatory Regulations (Medical and Non-Medical)
Canadian law defines what is acceptable as commercial fridges and freezers and stipulates manufacturing dates for appliances that will be accepted for sale. Natural Resources Canada which provides information to importers and dealers states that closed, commercial refrigerator-freezer should have been manufactured by January 1, 2010, and transparent fridge freezers should have been manufactured by January 1, 2012. It also states specific models that are acceptable for import and sale. In addition, there are accepted energy efficiency levels as shown in this table.
Specific Requirements (Medical)

Although household fridges and freezer may be used for medical purposes, they are expected to meet with specific requirements that include frosting, calibration, sensor, power, air distribution and alarm controls as listed here.
When these fridges/freezers are used for storing vaccines, the regulations become even more specific. There are information regarding temperatures and readings, organization of products, and cold chain which are listed here and here which will serve as a guide to anyone who wants to sell appliances for this specific purpose. If the products do not meet with these requirements, they will not be able to sell them in Canada. There is a resource here which contains sample fridges/freezers, already sold in Canada, which can be used for medical storage including storage of tissue samples.
Conclusion
Canada has specific guidelines for dealers and importers of fridges and freezers and these have to do with energy efficiency, date of manufacture and accepted models. There are more specific regulations when it comes to medical storage appliances and it will be a good idea to examine products that are already in sale in Canada with a view to seeing why they pass these regulatory requirements.

Sources
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