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See Chinese contents: YY/T 1465.5-2016 YY/T 1465.5-2016: Immunogenic evaluation method of medical devices--Part 5: Determination of α-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody
This Part of YY/T 1465 provides a method for determining the clearance rate of ¦Á-Gal antigen in medical devices of animal origin, which is suitable for the evaluation of the effectiveness of the ¦Á-Gal antigen clearance process. The method in this Part is applicable to materials that can fully expose the ¦Á-Gal antigen through grinding. If the ¦Á-Gal antigen cannot be fully exposed through grinding, other confirmed suitable methods may be considered.
