PDF
YY/T 1465.5-2016 Active
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
Abstract
This part of YY/T 1465 provides a method for determining the removal rate of alpha-Gal antigens in animal-derived medical devices, which is suitable for evaluating the effectiveness of the alpha-Gal antigen removal process.
The method in this part is applicable to materials that can fully expose alpha-Gal antigens through grinding. If the alpha-Gal antigens cannot be fully exposed through grinding, other confirmed suitable methods may be considered.
Note: Appendix A provides an example of the evaluation method of immunohistochemistry.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 1465.5-2016 |
| CCS | Medical devices |
| ICS | Medical materials |
| Implement Date | 2017-06-01 |
Price
$ 48
Subtotal
$ 48
Tax
$ 0.00
Order Total (incl. tax)
$ 48