Cold Chain and Refrigeration Standards

The World Health Organization (WHO) has created many performance specifications for different categories of refrigerators and freezers used by health-care facilities. It also lists the products of companies that comply with these specifications.

Standards are norms or requirements that establish a basis for the common understanding and judgment of materials, products, and processes. Standards are an invaluable tool in industry and business, because they streamline business practices and provide a level playing field for businesses to develop products and services. They are also critical to ensuring that products and services are safe for consumers and the environment.

In order to help designers and implementers of cold chain equipment, the World Health Organization (WHO) has developed a number of standards for equipment used to store, transport, and monitor cold chain–dependent products. These standards provide a basis for the procurement of quality equipment designed to meet the stringent specifications necessary for a robust and effective  Cold Chain and Refrigeration storage infrastructure.

The following table lists each of the relevant WHO standards by category. Each listing is also a link to the standard itself. Additionally, a link to a listing of equipment prequalified by WHO is provided for each category.

Note: Standards E01, E03, and E04 are applicable only to vaccine cold chain equipment, as blood has different cold chain requirements.

World Health Organization (WHO)

E01 Cold Rooms, Freezer Rooms, and Related Equipment

• WHO/PQS/E01/CR-FR01.2: Cold Rooms and Freezer Rooms

E03 Refrigerators and Freezers for Storing Vaccines and Freezing Ice-Packs

• Prequalified Equipment: Refrigerators and Freezers for Storing Vaccines and Freezing Ice-packs
• WHO/PQS/E03/FZ02.2: Ice-Pack Freezer
• WHO/PQS/E03/RF01.2: Refrigerator or Combined Refrigerator/Ice-Pack Freezer: Compression Cycle
• WHO/PQS/E03/RF02.2: Refrigerator or combined refrigerator/ice-pack freezer: Absorption Cycle
• WHO/PQS/E03/RF03.2: Ice-lined Refrigerator or Combined Refrigerator/Ice-Pack Freezer: Compression Cycle
• WHO/PQS/E03/RF04.2: Refrigerator or Combined Refrigerator/Ice-Pack Freezer:: Compression Cycle. For solar powered rechargeable battery storage
• WHO/PQS/E03/RF05.2: Refrigerator or Combined Refrigerator/Ice-Pack Freezer: Compression Cycle. For solar direct drive without battery storage
• WHO/PQS/E03/RF06.1: Refrigerator or Combined Refrigerator and Water-Pack Freezer: Compression Cycle. Solar direct drive with ancillary rechargeable battery
• WHO/PQS/E03/PV01.2: Solar Power System for Compression-Cycle Vaccine Refrigerator or Combined Refrigerator/Ice-Pack Freezer

E04 Cold Boxes and Vaccine Carriers

• Prequalified Equipment: Cold Boxes and Vaccine Carriers
• WHO/PQS/E04/CB01.1: Vaccine Cold Box
• WHO/PQS/E04/VC01.1: Vaccine Carrier

E05 Ice-packs, Cool-packs and Warm-packs

• Prequalified Equipment: Ice-Packs, Cool-Packs, and Warm-Packs
• WHO/PQS/E05/IP01.1: Water Packs: Ice-Packs, Cool-Packs, and Warm-Packs

E06 Temperature Monitoring Devices

• Prequalified Equipment: Temperature Monitoring
• WHO/PQS/E06/AL01.1: Acoustic and/or Visual Alarm Units
• WHO/PQS/E06/IN02.1: Cold Chain Monitor
• WHO/PQS/E06/IN03.1: Irreversible Freeze Indicator
• WHO/PQS/E06/IN05.2: Vaccine Vial Monitor
• WHO/PQS/E06/TH01.1: Portable Electronic Thermometer
• WHO/PQS/E06/TH02.2: Fixed Gas or Vapour Pressure Dial Thermometer
• WHO/PQS/E06/TH03.1: Portable Alcohol Stem Thermometer
• WHO/PQS/E06/TH06.2: Integrated Electronic Thermometer, with or without Alarm Function, for Vaccine Refrigerators and Freezers
• WHO/PQS/E06/TR03.1: Programmable Electronic Temperature and Event Logger Systems with Integral Alarm and Auto-Dialer Options
• WHO/PQS/E06/TR04.1: Wall-Mounted Pen Recording Thermometer
• WHO/PQS/E06/TR05.1: User programmable temperature data loggers
• WHO/PQS/E06/TR06.3: 30-day Electronic Refrigerator Temperature Logger
• WHO/PQS/E06/TR07.1: Electronic Shipping Indicators