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
3. By determining the R-value
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.
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.