This standard specifies the terms and definitions, classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of hematology analyzers. This standard applies to blood analyzers (hereinafter referred to as analyzers) that perform qualitative and quantitative analysis of formed components in human blood and provide relevant information. This standard does not apply to reticulocyte analyzers.
YY/T 0653-2008 Referenced Document
GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment*, 2009-11-15 Update
GB/T 191-2008 Packaging.Pictorial marking for handling of goods
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied