YY/T 1500-2016 in English

This standard outlines the procedures for conducting the monocytic activation test using the human whole blood ELISA method to assess pyrogenic properties of medical devices. It provides detailed guidelines on sample preparation, test conditions, and the measurement of specific biological responses. The document includes information on the reagents, equipment, and operational steps required to perform the test accurately and consistently. It also specifies the criteria for interpreting test results and reporting them in a standardized format. The standard is applicable to medical devices that may come into contact with the human body and are suspected of causing pyrogenic reactions. It aims to ensure the safety and effectiveness of medical devices through reliable and reproducible testing methods. The standard covers various aspects of the test, including validation, quality control, and data analysis, to support the overall evaluation of medical device safety.