This Part of YY/T 1465 provides a method for the determination of plaque-forming cells by agar gel solid-phase method. This Part is suitable for evaluating the impact of medical devices/materials on the body's humoral immune function.
Basic Data
Standard ID
YY/T 1465.3-2016 (YY/T1465.3-2016)
Description (Translated English)
Immunogenic evaluation method of medical devices - Part 3: Plaque forming cells assay - Agar gel solid-phase method
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Word Count Estimation
8,877
Date of Issue
2016-07-29
Date of Implementation
2017-06-01
Regulation (derived from)
State Food and Drug Administration Notice 2016 (No.129)
