YY/T 0606.15-2014
Tissue engineered medical products.Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests (English Version)
- Standard No.
- YY/T 0606.15-2014
- Language
- Chinese, Available in English version
- Release Date
- 2014
- Published By
- Professional Standard - Medicine
- Status
- 2024-01
- Replace By
- YY/T 0606.15-2023
- Latest
- YY/T 0606.15-2023
- Scope
- This part of YY/T 0606 specifies the test method for evaluating mammalian cellular immune responses caused by tissue engineering medical product matrices or scaffolds: lymphocyte proliferation test. 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 0606.15-2014 history
- 2023 YY/T 0606.15-2023 Test methods for evaluating the immune response of matrices and scaffolds in tissue-engineered medical products: Lymphocyte proliferation test
- 2014 YY/T 0606.15-2014 Tissue engineered medical products.Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests
