This white paper is about the IEC 61010 family of standards focusing on laboratory equipment. The 2-011:2016 and 2-012:2016 distinctions of the IEC 61010 go in-depth to specifically address refrigerated systems in laboratory equipment. This paper will explore the differences between the two standards and the specifics required for laboratory equipment.
Laboratory refrigerators are used to cool samples or specimens for preservation. They include refrigeration units for storing blood plasma and other blood products, as well as vaccines and other medical or pharmaceutical supplies. Laboratory refrigerators that comply with regulations from agencies such as the U.S. Food and Drug Administration (FDA) are designed to provide specific levels of temperature control and a uniform temperature throughout the chamber. These instruments allow the storage of reagents and samples over an extended period of time. Refrigerators are widely used for the storage of enzymes, buffers, dyes etc., and prevent them from temperature-associated degradation.
Refrigeration plays a vital role in the laboratory environment. To help ensure safety from materials through operation, the IEC61010 examines complete refrigeration environments that could present performance or hazard related issues. Understanding the IEC 61010 family of standards and how they apply to equipment and systems will prove valuable to compliance preparation.