YY/T 0606.20-2014Tissue engineered medical products - Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products:Cell migration tests (English PDF)

Foreword

YY/T 0606 standard total entitled "tissue-engineered medical products" have or plan to release the following sections.

--- Part 2. Terminology;

--- Part 3. General classification;

--- Part 4. skin substitute (object) of the terminology and classification;

--- Part 5. Matrix and stent performance and testing;

--- Part 6. I collagen;

--- Part 7. chitosan;

--- Part 8. sodium alginate;

--- Part 9. sodium hyaluronate;

--- Part 10. In vivo evaluation of the repair or regeneration of articular cartilage implants;

--- Part 12. cells, tissues, organs processing guide;

--- Part 13. automatic cell counting;

--- Part 14. Test methods and evaluation matrix scaffold immune response. ELISA method;

--- Part 15. Test method for evaluating the immune response matrix and bracket. Lymphocyte proliferation assay;

--- Part 16. Saving Guide;

--- Part 17. exogenous factor evaluation guidelines;

--- Part 18. alginate gel or microencapsulated fixed guide;

--- Part 19. Repair and replacement of bone tissue implant bone formation activity in vivo evaluation guidelines;

--- Part 20. Test methods and evaluation matrix scaffold immune response. cell migration test;

--- Part 24. resorbable biomaterial implant evaluation test specification;

--- Part 25. materials of animal origin DNA residues in biological assays. Fluorescence staining;

--- Part 26. polymer scaffold microstructure evaluation guidelines. This section YY/T Part of 200,606. This section drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

YY/T 0606 provisions of this part of the trial due to the mammalian immune response cells of tissue engineered medical products evaluation matrix or scaffold Test method. cell migration assay.

This section applies to biological evaluation of medical products for tissue engineering scaffold or matrix.

NOTE: Although this section of the test may also be used to detect human specimens or for research purposes, and provides data for clinical track, but not on the human body shape Diagnostic testing conditions.

In addition to this part of the selected method, but may adopt other equivalent method.

Not all materials and applications are required in accordance with this section for detection and therefore should carefully consider the applicability of the method in this section. in Before the implementation of this part of the recommended test, the test results should be considered GB/T 16886.1 or administration recommended the prompt information.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test Tests for local effects after implantation. GB/T 16886.6 Biological evaluation of medical devices - Part 6

GB/T 16886.10 Biological evaluation of medical devices - Part 10.

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

YY/T 0606.3 tissue-engineered medical products - Part 3. General Category

YY/T 0606.5 tissue-engineered medical products - Part 5. Matrix and stent performance and testing ISO /T S10993-20 Biological evaluation of medical devices - Part 20. Immune toxicology test principles of medical devices and methods (Bio-logicalevaluationofmedicaldevices-Part 20. Principlesandmethodsforimmunotoxicologytestingof medicaldevices)

3 Terms and Definitions

The following terms and definitions apply to this document.