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Are You Ready for NSF 456 for Vaccine Refrigerators and Freezers?

Introduction to new NSF 456 standard

Doctor retrieving vaccine from refrigerator.

February 23, 2021

The race to vaccinate against SARS-CoV-2, the virus that causes COVID-19, has dominated the public health landscape for over a year. Vaccines are considered a key strategy for halting the current pandemic that has been attributed to over two million deaths globally. The reality is that COVID-19 vaccines join an ever-growing family of immunizations for viral and bacterial illnesses. Vaccines are recommended for flu season (influenza), traveling to some foreign countries or for occupational purposes, such as anthrax. For children under the age of 6, the Centers for Disease Control and Prevention (CDC) recommends numerous vaccines and boosters to offer protection from a variety of serious diseases, including polio, the measles and chicken pox (varicella) to name a few. 

The growing need for vaccine storage has given rise to a unique class of specialized refrigerators and freezers. To ensure maximum effectiveness, shelf life and safety, vaccines depend on storage and delivery devices with reliable temperature stability. Temperature control requirements for vaccine refrigerators and freezers are generally more precise and sophisticated than their typical household counterparts. Furthermore, temperature monitoring capabilities are required per CDC guidelines. 

To ensure vaccine storage equipment meets applicable safety requirements, refrigerating and freezing appliances used specifically for vaccine storage are assessed to UL 60335-2-24, the Standard for Household Refrigeration Equipment; UL 60335-2-89, the Standard for Commercial Refrigeration Equipment; or UL 61010-2-011, the Standard for Refrigerated Laboratory Equipment. Any of these Standards can be used to evaluate and mitigate the risk of electrical shock, casualty and fire hazards. 

Just as important as the safe operation of vaccine storage appliances is ensuring that the equipment performs as intended to preserve the viability of each dose. For that purpose, a new American national standard is in development for vaccine refrigeration equipment and freezers. The draft standard is NSF 456, Vaccine Storage, and it focuses on the design and performance of products that are intended to hold vaccines at proper refrigeration or freezing temperatures. According to the scope of the draft document, it will cover refrigerators, freezers and combination units that are comprised of separate refrigerator and freezer sections.

The draft NSF 456 document was presented for public review and comment on Dec. 16, 2020, scheduled to conclude Feb. 15, 2021. While we cannot speculate on the final outcome of the standard or potential date of commission, UL will be prepared to test to this new standard as soon as it becomes available.