YY/T 0653-2017 (English Version) PDF

Scope: This standard specifies the terms and definitions, product classification, technical requirements, test methods, labels, markings and instructions for use, packaging, transportation and storage of hematology analyzers. This standard applies to blood analyzers (hereinafter referred to as analyzers) that analyze the formed components in human blood and provide relevant information. This standard does not apply to reticulocyte testing.

YY/T 0653-2017 Referenced Document

GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use.Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 1:General requirements
GB/T 18268.26 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 29791.1 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
GB/T 29791.3 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use
YY 0648 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment