YY/T 1465.5-2016: Immunogenic evaluation method of medical devices - Part 5: Determination of ��-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibod
This Part of YY/T 1465 provides a method for determining the clearance rate of α-Gal antigen in medical devices of animal origin, which is suitable for the evaluation of the effectiveness of the α-Gal antigen clearance process. The method in this Part is applicable to materials that can fully expose the α-Gal antigen through grinding. If the α-Gal antigen cannot be fully exposed through grinding, other confirmed suitable methods may be considered. Note. Appendix A gives examples of immunohistochemistry evaluation methods.
Basic Data
Standard ID
YY/T 1465.5-2016 (YY/T1465.5-2016)
Description (Translated English)
Immunogenic evaluation method of medical devices - Part 5: Determination of ??-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibod
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C30
Word Count Estimation
12,167
Date of Issue
2016-07-29
Date of Implementation
2017-06-01
Regulation (derived from)
State Food and Drug Administration Notice 2016 (No.129)
