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YY/T 1562-2017: Tissue engineering medical device products - Biomaterial scaffolds - Guide for cell viability evaluation
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1562-2017 | English | 279 |
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Tissue engineering medical device products - Biomaterial scaffolds - Guide for cell viability evaluation
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YY/T 1562-2017
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PDF similar to YY/T 1562-2017
Standard similar to YY/T 1562-2017 YY/T 1680 YY/T 1561 YY/T 1571 YY/T 1553 Basic data | Standard ID | YY/T 1562-2017 (YY/T1562-2017) | | Description (Translated English) | Tissue engineering medical device products - Biomaterial scaffolds - Guide for cell viability evaluation | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,128 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1562-2017: Tissue engineering medical device products - Biomaterial scaffolds - Guide for cell viability evaluation
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Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Tissue engineering medical equipment products biomaterials brackets
Guide to cell activity testing
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Organization Engineering Medical Devices Products Technical Committee
(SAC/TC110/SC3) centralized.
This standard drafting unit. Chinese PLA Fourth Military Medical University, China Institute of Food and Drug Control.
The main drafters of this standard. Rock, Zhang Yongjie, Xu Liming, Luo waves, Shao Anliang, Fang Yu, pay the ocean.
Introduction
The number and distribution of active cells and inactive cells on the surface or inside the biomaterial scaffolds is critical for the construction of cell/biomaterial scaffolds
One of the important characteristics of the product performance, but also one of the indicators to evaluate the cell compatibility of the biomaterial scaffold. Therefore, as used to repair and
It is necessary to standardize the method for the quantitative detection of cell viability by reproducing important parameters of tissue engineering products for defects or diseased tissues.
Although cellular activity is a very important property for tissue engineering medical products (TEMP), the biological activity of TEMP
Affected by other parameters. Other assays are recommended for assessing and determining cell type, protein expression, gene mapping, differentiation and
Degree, activation status, morphology and other characteristics.
It is recommended that basic biocompatibility testing of biomaterial scaffolds be completed prior to use of biomaterial scaffold composite cells in accordance with the relevant requirements.
Tissue engineering medical equipment products biomaterials brackets
Guide to cell activity testing
1 Scope
This standard gives guidance on the evaluation of cell viability in the biological evaluation of biomaterial scaffolds.
This standard applies to tissue engineering medical device products of biological materials stent.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Tissue engineering medical products - Part 13. Automatic counting of cells
YY/T 0606.25 Tissue engineering medical products - Part 25. Determination of DNA residue of animal-derived biomaterials - Fluorescent staining
Color method
3 Terms, definitions and abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1
Active cells viablecel
Able to carry out metabolic activity, structural integrity, with functional cell membrane cells.
3.1.2
Inactive cells non-viablecel
Cells that do not meet any one of the activity criteria listed in 3.1.1.
3.1.3
Biomaterialscaffolds Biomaterialscaffolds
Having a cell or bioactive factor migration, binding or transport function, a support for replacing, repairing or regenerating the tissue, releasing the carrier or
Matrix for the diagnosis, treatment, repair or replacement of body tissues and organs or to enhance their function.
3.2 Abbreviations
The following abbreviations apply to this document.
BrdU. Bromodeoxyuridine (5-bromo-2-deoxyUridine);
calcein AM; calceinacetoxymethylester;
DAPI 4,6-diamidino-2-phenylindole;
G6PD glucose-6-phosphate dehydrogenase;
LDH; lactate dehydrogenase;
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