T/GDMDMA 0043-2025 Blood gas/electrolyte analyzer
T/GDMDMA 0043-2025 Blood gas/electrolyte analyzer
Basic Information
Scope
This document specifies the basic parameters, requirements, test methods, labels, markings, user manuals, packaging, transportation, and storage for blood gas/electrolyte and metabolite analyzers. This document applies to blood gas/electrolyte and metabolite analyzers that use electrodes as sensors and conduct electrochemical testing on human blood samples or other bodily fluid samples for blood gas parameters such as pH, partial pressure of carbon dioxide (pCO2), and partial pressure of oxygen (pO2), electrolyte parameters including sodium ion (Na+), potassium ion (K+), chloride ion (Cl-), and calcium ion (Ca2+), and metabolite parameters such as glucose (Glu) and lactate (Lac). Note: Analytical instruments that include all or some of the above-mentioned items and use the same detection methods as described above may refer to this document for implementation, including but not limited to blood gas/electrolyte and metabolite analyzers.