July 6, 2022
On May 2, 2022, the World Health Organization (WHO) issued accreditation for UL LLC for testing vaccine storage refrigeration devices to the WHO PQS E003 series of standards. These standards establish a set of performance requirements specific for refrigeration equipment. The performance requirements focus on criteria to safely store vaccines at specific temperatures for long periods of time. The standards take into account power dips, power outages and the normal workflow of removing vaccines for use and replacing them with new stock.
The WHO accreditation expands the capabilities of our network of laboratories. We are now able to test to WHO PQS E003 in our facilities in:
- Northbrook, IL USA
- Carugate, Italy
- New Delhi, India
In addition to our WHO PQS accreditation, UL Solutions maintains ISO/IEC 17025 accreditations through International Accreditation Service (IAS).
Regulation updates
Products needing WHO’s vaccine storage certifications may also need to meet certification requirements to IEC 61010-1 and IEC 61010-2-011, or UL 471, the Standard for Commercial Refrigerators and Freezers, to meet the basic safety requirements for refrigeration equipment used in commercial or laboratory environments. UL Solutions can also issue CB Scheme (IEC 61010-1) test reports and certifications or NRTL listings required for these product types.
Associated requirements
UL Solutions offers IEC 61326-1 testing for laboratory equipment subject to electromagnetic compatibility (EMC) requirements.
Since 2019, laboratory equipment used in U.S. hospitals must meet emissions and immunity requirements covered in IEC 60601-1-2. This standard includes a risk management process to establish requirements for immunity tests. But manufacturers may test to IEC 61326-1, as long as a similar risk management process was followed.
The laboratory accreditation to this program can be viewed here.
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