T/CAS 859-2024 Active

Scope: This document specifies the technical requirements, test methods, outer packaging information, and user manuals for clinical detection reagents of liquid chromatography-mass spectrometry (LC-MS) technology. This document applies to the research, development, production, and use of clinical detection reagents or kits based on LC-MS technology. Main technical content: 1. Scope: This document specifies the technical requirements, test methods, outer packaging information, and user manuals for clinical detection reagents of LC-MS technology. This document applies to the research, development, production, and use of clinical detection reagents or kits based on LC-MS technology. 2. Normative reference documents: The content of the following documents is an essential part of this document through normative references. Among them, the referenced documents with a specified date only apply to the version corresponding to that date; for the unspecified date referenced documents, the latest version (including all amendment sheets) applies to this document. GB/T 21415 - In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of calibrators and control substances GB/Z 43280 - Medical laboratories - Guidelines for evaluation of measurement uncertainty WS/T 804 - Basic technical standards for clinical chemistry testing T/CAS 678 - General technical requirements for liquid chromatography-mass spectrometry used in clinical therapeutic drug monitoring