This document stipulates the testing quality requirements for laboratories during the performance verification process of immunochromatography kits, including requirements for personnel, environment, instruments, testing process control, and test result analysis. This document is applicable to testing laboratories that verify the performance of immunochromatographic kits for in vitro diagnostics, including manufacturing enterprise laboratories.
YY/T 1915-2023 Referenced Document
GB/T 27025 General requirements for the competence of testing and calibration laboratories
YY/T 1915-2023 history
2023YY/T 1915-2023 General rules for laboratory testing of immunochromatographic kits