YY/T 1939-2024 Test for bacterial endotoxins of medical devices - Recombinant factor C method
1 Scope
This document describes a test method for the determination of bacterial endotoxin content in medical devices by the recombinant factor C method.
It is applicable to the detection of bacterial endotoxins of medical devices.
2 Normative references
No normative reference is listed in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
factor C
protein that is sensitive to bacterial endotoxins and can identify endotoxins selectively in TAL
3.2
recombinant factor C
recombinant protein expressed in eukaryotic cells and generated from factor C (3.1) in TAL via gene recombination technology
4 Test principle
Recombinant factor C method is a method to determine the content of endotoxin by using the change of fluorescence signal during the reaction between recombinant factor C reagent and endotoxin. The recombinant factor C is activated after binding with bacterial endotoxin, transforming from inactive proteinogen to biologically active proteinase, which can recognize and catalyze the downstream fluorescent substrate to generate fluorescence signals, and the intensity of fluorescence signal is proportional to the concentration of endotoxin. Measure and correct the fluorescence values of recombinant factor C reagent and test sample solution respectively before and after incubation, then calculate the content of bacterial endotoxin in test sample via standard curve.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Test principle
5 Main equipment
6 Reagents and materials
7 Preparation of test sample solution
8 Test procedures
9 Calculation and evaluation of results
10 Test report
Bibliography
