This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, signs and instructions for use, packaging, transportation and storage of fully automatic biochemical analyzers (hereinafter referred to as analyzers). This standard applies to analyzers that use liquid reagents for quantitative analysis of various samples.
YY/T 0654-2008 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 Packaging.Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied