规定了在10摄氏度至43摄氏度环境温度范围内用于储存2摄氏度至6摄氏度血液和血液制品，以及在-25摄氏度或更低温度下冷冻血浆和血浆制品的医用制冷设备的制造要求。

Specifies requirements for the manufacture of medical refrigeration equipment used within an ambient temperature range of 10 degrees Celsius to 43 degrees Celsius for the storage of blood and blood products in the temperature range 2 degrees Celsius to 6 degrees Celsius and frozen plasma and plasma products at a temperature of minus 25 degrees Celsius or lower.