This standard specifies the classification and basic parameters, requirements, test methods, signs, labels, instructions for use and packaging, transportation and storage of electrolyte analyzers. This standard applies to electrolyte analyzers (hereinafter referred to as instruments) using ion-selective electrodes as sensors. The instrument is suitable for human clinical electrolyte testing. The electrolyte module on the biochemical analyzer can refer to this standard.
YY/T 0589-2016 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