This standard specifies the terms and definitions, requirements, test methods, signs, labels and instructions for use, packaging, transportation and storage of dry chemical urine analyzers. This standard applies to urine analyzers (hereinafter referred to as analyzers) that analyze urine analysis test strips based on dry chemistry principles.
YY/T 0475-2011 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
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
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
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update