YY/T 0589-2016
Electrolyte analyzer (English Version)

Standard No.
YY/T 0589-2016
Language
Chinese, Available in English version
Release Date
2016
Published By
Professional Standard - Medicine
Latest
YY/T 0589-2016
Replace
YY/T 0589-2005
Scope
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

YY/T 0589-2016 history

Electrolyte analyzer



Copyright ©2024 All Rights Reserved