YY/T 1562-2017Tissue engineering medical device products-Biomaterial scaffolds-Guide for cell viability evaluation (English PDF)
组织工程医疗器械产品生物材料支架细胞活性试验指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1562-2017 is the English-translated version of 组织工程医疗器械产品生物材料支架细胞活性试验指南.
YY/T 1562-2017 is the Chinese pharmaceutical industry standard that guides the evaluation of cell viability in the biological assessment of a biomaterial scaffold for tissue engineering products.
It sets out the cells and the culture conditions, the contact with the scaffold or its extract, the assays by which viability is measured, the controls and the interpretation of the result. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1562-2017
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms, definitions and abbreviations
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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.
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 document. 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
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;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
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Related Standards
YY/T 0606.25-2014 — Tissue engineered medical product - Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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