JJF 1644-2017 in English

This document provides guidelines for the preparation and characterization of clinical enzymology reference materials. It outlines the procedures and requirements necessary to ensure the accuracy, stability, and traceability of these materials. The content covers aspects such as material selection, production processes, validation methods, and quality control measures. It also addresses the documentation and certification of reference materials to support their use in clinical laboratories and related applications. The document is intended to assist laboratories and manufacturers in producing high-quality reference materials that meet the needs of the clinical enzymology field. It includes detailed information on the evaluation of performance characteristics and the establishment of measurement traceability. The scope of the document is focused on the development of reference materials used in the measurement of enzyme activities in clinical settings.