YY/T 0606.14-2014 Tissue engineered medical products.Part 14:Standard practice for evaluation of immune responses of substrate and scaffolds products:ELISA tests (English Version)
This part of YY/T 0606 specifies the test method for evaluating the humoral immune response of mammals caused by tissue engineering medical product matrices or scaffolds: ELISA method. This section applies to the biological evaluation of tissue engineering medical product matrices or scaffolds. In addition to the methods selected in this section, other equivalent methods may be adopted. Not all materials and applications require testing in accordance with this section, so the applicability of the methods in this section should be carefully considered. Before implementing the tests recommended in this section, the information prompted by the test results recommended by GB/T 16886.1 or the regulatory department should be considered.
YY/T 0606.14-2014 history
2014YY/T 0606.14-2014 Tissue engineered medical products.Part 14:Standard practice for evaluation of immune responses of substrate and scaffolds products:ELISA tests