Blood Safety and Quality Regulations underpinned by accreditation
Since the introduction of the UK Blood Safety and Quality Regulations, the correct storage of red blood cells and other blood products such as plasma and platelets has been heavily regulated. This is why all refrigerators, freezers and incubators that store blood products like red cells, plasma and platelets have to be fitted with a number of features, must be temperature mapped, regular maintenance and have annual UKAS accredited calibration. They are also, under EU rulings, classed as ‘borderline medical devices’. This means any new blood refrigerator; plasma freezer or platelet incubator or agitator should come from a manufacturer that holds accredited certification to ISO 13485 so their products are designed and manufactured in compliance with EU Directive 93/42/EC (class IIa).
Further information is available here.