This Standard specifies the classification and basic parameters, requirements, test methods, signs, labeling, instruction manual and packaging, transportation, and storage of electrolyte analyzers. This Standard applies to electrolyte analyzers which use ion-selective electrodes as sensors (hereafter referred to as instruments); the instruments are suitable for human clinical electrolyte testing. The electrolyte module on the biochemical analyzer can refer to this Standard.
Basic Data
Standard ID
YY/T 0589-2016 (YY/T0589-2016)
Description (Translated English)
Electrolyte analyzer
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
12,135
Date of Issue
2016-03-23
Date of Implementation
2017-01-01
Older Standard (superseded by this standard)
YY/T 0589-2005
Regulation (derived from)
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
