T/CAS 841-2024 Heart biomarker real-time inspection quality control technical requirements

Scope

Scope: This document specifies the basic and technical requirements for quality control of instant tests for cardiac markers. This document is applicable to instant tests for cardiac markers in all levels and types of medical institutions. Main technical content: 1. Scope: This document specifies the basic and technical requirements for quality control of instant tests for cardiac markers. This document is applicable to instant tests for cardiac markers in all levels and types of medical institutions. 2. Normative references: 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; the referenced documents without a specified date apply to the latest version (including all amendment sheets) of these documents. GB/T 22576.1—2018 Medical Laboratories—Requirements for Quality and Competence—Part 1: General Requirements GB/T 29790—2020 Requirements for Quality and Competence of Instant Tests WS/T 415—2013 Methods for Evaluating Laboratory Tests without Interlaboratory Quality Evaluation WS/T 641—2018 Internal Quality Control for Clinical Laboratory Quantitative Determinations WS/T 644—2018 Interlaboratory Quality Evaluation for Clinical Laboratories DB11/T 1240—2015 Quality and Technical Requirements for Medical Laboratories ISO 15189:2022 Medical Laboratories—Requirements for Quality and Competence

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