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YY/T 0606.20-2014: Tissue engineered medical products. Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products: Cell migration tests
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| YY/T 0606.20-2014 | English | 189 |
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Tissue engineered medical products. Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products: Cell migration tests
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YY/T 0606.20-2014
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Basic data | Standard ID | YY/T 0606.20-2014 (YY/T0606.20-2014) | | Description (Translated English) | Tissue engineered medical products. Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products: Cell migration tests | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 8,879 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 16886.1; GB/T 16886.6; GB/T 16886.10; GB/T 16886.12; YY/T 0606.3; YY/T 0606.5; ISO/TS 10993-20 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to biological evaluation of tissue-engineered medical products matrix or scaffold. This Standard specifies the evaluation of tissue-engineered medical products matrix or scaffold due to test methods for mammalian cell immune response | YY/T 0606.20-2014: Tissue engineered medical products. Part 20: Standard practice for evaluation of immune responses of substrate and scaffold products: Cell migration tests
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Tissue engineered medical products.Part 20. Standard practice for evaluation of immune responses of substrate and scaffold products. Cell migration tests
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Tissue Engineered Medical Products
Part 20. Evaluation of the immune response matrix and bracket
Test Methods. Cell migration test
Part 20. Standardpracticeforevaluationofimmuneresponsesof
substrateandscaffoldproducts. Celmigrationtests
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
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.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the jurisdiction of the Chinese Institute of Food and Drug test.
This section is drafted. PLA Institute of Burns, First Affiliated Hospital, Third Military Medical University, Chinese Academy of Food and Drug test.
This section explains accredited by the China Institute of Food and Drug.
The main drafters of this section. PENG Dai-chi, Fang Yu, Zhou Ling, Zhang Na, Liu Jing, Feng Xiaoming.
Tissue Engineered Medical Products
Part 20. Evaluation of the immune response matrix and bracket
Test Methods. Cell migration test
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. irritation and delayed-type hypersensitivity test
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.
3.1
Matrix substrate
Tissue-engineered medical products as the growth of cells or biomolecules, support or delivery vehicle of raw materials.
3.2
Bracket scaffold
Alternative, repair or regeneration of tissue cells or biologically active factors migration, binding or transporting a support, carrier or matrix release.
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