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(Tissue-engineered medical products-Test method for evaluating the immune response of matrices and scaffolds: Lymphocyte proliferation assay)
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| YY/T 0606.15-2014 | English | 279 |
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Tissue engineered medical products. Part 15: Standard practice for evaluation of immune responses of substrate and scaffolds products: Lymphocyte proliferation tests
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Basic data
| Standard ID | YY/T 0606.15-2023 (YY/T0606.15-2023) |
| Description (Translated English) | (Tissue-engineered medical products-Test method for evaluating the immune response of matrices and scaffolds: Lymphocyte proliferation assay) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C45 |
| Classification of International Standard | 11.040.30 |
| Word Count Estimation | 13,158 |
| Date of Issue | 2023-01-13 |
| Date of Implementation | 2024-01-15 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the test method for evaluating the immune response of mammalian cells induced by matrix or scaffold of tissue engineering medical products: lymphocyte proliferation test. This standard applies to the biological evaluation of matrix or scaffold of tissue engineering medical products. |
YY/T 0606.15-2023: (Tissue-engineered medical products-Test method for evaluating the immune response of matrices and scaffolds: Lymphocyte proliferation assay)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.30
CCSC40
Pharmaceutical Industry Standard of the People's Republic of China
Replace YY/T 0606.15-2014
Tissue Engineering Medical Product Evaluation Substrates and Scaffolds
Test method for immune response. Lymphocyte proliferation assay
Released on 2023-01-13
2024-01-15 Implementation
Released by the State Drug Administration
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 1
5 Lymphocyte Proliferation Assay 2
5.1 Principle 2
5.2 Materials and test specimens 2
5.3 Experimental design grouping 2
5.4 Recommended Operation Step 3
6 Data Analysis 3
6.1 Antigen stimulation in vitro 3
6.2 Antigen stimulation in vivo 3
Appendix A (Informative) CFSE Lymphocyte Proliferation Test 4
Reference 8
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document replaces YY/T 0606.15-2014 "Tissue Engineering Medical Products Part 15.Tests for Evaluating Immunoreactivity of Matrix and Scaffolds"
Test Method. Lymphocyte Proliferation Test", compared with YY/T 0606.15-2014, except for structural adjustment and editorial changes, the main technical changes
Converted as follows.
---Modified the third paragraph of "Scope" as a note (see Chapter 1, Chapter 1 of the.2014 edition);
--- Delete the fourth paragraph of "Scope" and include it after editorial revision (Chapter 1 of the.2014 edition);
--- Deleted ISO /T S10993.20, YY/T 0606.3, YY/T 0606.5 in the normative reference documents (see the.2014 edition
chapter 2);
--- Modified the definition of bracket (see 3.2, 3.2 of the.2014 edition);
--- Added abbreviations (see Chapter 4);
---Increased the note of antigen stimulation in vivo (see 5.3.2);
--- Modified the number of parallel tubes of the specimen (see 5.4.2, 5.4.2 of the.2014 edition);
--- Added CCK-8 and CFSE as detection methods for lymphocyte proliferation (see 5.4.5);
--- Modify the suspension section as a second-level entry, and modify the number of parallel holes of the specimen (see 5.4.6, 5.4.7, 5.4 of the.2014 edition);
---Increase the analysis index of lymphocyte proliferation test (see Chapter 6).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is organized by the National Standardization Technical Committee of Surgical Implants and Orthopedic Devices Engineering Medical Device Products Sub-Technical Committee
(SAC/TC110/SC3) centralized.
This document is drafted by. China Institute for Food and Drug Control, Beijing Institute for Medical Device Testing.
The main drafters of this document. Chen Liang, Chen Liyuan, Dai Zhengning, He Xueying, Du Xiaodan, Shao Anliang, Wei Lina.
The release status of previous versions of this document and the documents it replaces are as follows.
---First released in.2014 as YY/T 0606.15-2014;
--- This is the first revision.
Tissue Engineering Medical Product Evaluation Substrates and Scaffolds
Test method for immune response. Lymphocyte proliferation assay
1 Scope
This document specifies the test method for evaluating the immune response of mammalian cells induced by matrix or scaffold of tissue engineered medical products. Lymphocyte
Cell Proliferation Assay.
This document is applicable to the biological evaluation of matrix or scaffold for tissue engineering medical products.
Note. In addition to the method selected in this document, other equivalent methods can be adopted.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 16886.6 Biological evaluation of medical devices - Part 6.Local reaction test after implantation
GB/T 16886.10 Biological evaluation of medical devices - Part 10.Irritation and skin sensitization tests
GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
matrixsubstrate
Raw materials used as cell or biomolecule growth, support or delivery vehicles in tissue engineered medical products.
3.2
bracket scaffold
Supports, structural elements, delivery vehicles or matrices consisting of materials of synthetic and/or natural origin for the modulation of biological functions (including
(including but not limited to adhesion, migration, proliferation, differentiation), or the translocation of exogenous and/or endogenous cells, and/or the combination of biologically active factors and
delivery.
[Source. ISO /T S21560.2020, definition 3.14]
4 Abbreviations
The following abbreviations apply to this document.
AlamarBlue. Alamar Blue (AlamarBlueKit)
BSA. Bovine Serum Albumin (BovineSerumAlbumin)
...
