YY/T 1849-2022 English PDF

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YY/T 1849-2022: Recombinant collagen protein
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1849-2022	359	Add to Cart	4 days	Recombinant collagen protein	Valid

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Basic data

Standard ID: YY/T 1849-2022 (YY/T1849-2022)
Description (Translated English): Recombinant collagen protein
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 18,150
Issuing agency(ies): State Drug Administration

YY/T 1849-2022: Recombinant collagen protein

---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.
Recombinant collagen protein ICS 11.040.30 CCSC30 People's Republic of China Pharmaceutical Industry Standard Recombinant collagen Published on 2022-01-13 2022-08-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Quality Control 2 4.1 General 2 4.2 Quality control of the preparation process 2 4.3 Quality control of recombinant collagen 2 5 Test items, requirements and test methods 2 5.1 General 2 5.2 Physical and chemical items 3 5.3 Identification 4 5.4 Purity 4 5.5 Impurities, contaminants and additives5 5.6 Content 6 5.7 Structural Characterization 6 5.8 Biological functions 7 5.9 Safety test 8 6 Stability9 7 Biological evaluation9 8 Packaging, transport and storage9 Appendix A (Informative) Characterization of Recombinant Collagen10 Appendix B (normative) Determination of Cell Adhesion --- Centrifugation 12 Appendix C (normative) cell migration test --- cell scratch method 14 Reference 15

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 of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of China National Institute for Food and Drug Control. This document is drafted by. China National Institute for Food and Drug Control, Sichuan Institute of Drug Inspection (Sichuan Medical Device Testing Center), Shandong Institute of Medical Device and Drug Packaging Inspection, Peking University School of Stomatology Oral Medical Device Inspection Center, Shaanxi Giant Biotechnology Technology Co., Ltd., Shanxi Jinbo Biomedical Co., Ltd., Jiangsu Chuangjian Medical Technology Co., Ltd., Jiangsu Jiangshan Juyuan Biotechnology Co., Ltd. Ltd. The main drafters of this document. Chen Liang, Liu Xinglan, Hou Li, Han Jianmin, Xu Liming, Duan Zhiguang, Li Haihang, Wang Jian, Zhao Jianfeng, Zhao Daiguo, Wang Luanluan, Wang Juexiao, Fan Xingliang, Wu Yang, Jiang Ruodan, Lan Wanling, Gai Xiaoxiao, Yan Jianya, Sun Dandan, Tian Xudong, Huang Jianmin. Recombinant collagen

1 Scope

This document specifies the quality control requirements, detection indicators and detection methods of recombinant collagen. This document applies to the quality control of recombinant collagen as a raw material for medical devices. Note. In view of the current technological research and development status, the recombinant collagen in this document mainly refers to the product of human-based collagen gene recombination. based on non-human glue The recombinant collagen or collagen-like product of the original protein gene can refer to this document, but it needs to be qualitatively carried out according to the specific product characteristics and production process. volume control.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process GB/T 16886.20 Biological Evaluation of Medical Devices Part 20.Principles and Methods of Immunotoxicology Tests for Medical Devices GB 18278.1 Moist heat for sterilization of healthcare products - Part 1.Development, validation and routine control of the sterilization process for medical devices Require GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices system requirements GB 18280.1 Sterilization Radiation for Healthcare Products Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices Require YY/T 1453 Method for Characterization of Type I Collagen in Tissue Engineering Medical Device Products YY/T 1465 (all parts) Method for evaluating the immunogenicity of medical devices YY/T 1805.2 Collagen for tissue engineering medical device products-Part 2.Molecular weight determination of type I collagen Twelve Sodium alkyl sulfate polyacrylamide gel electrophoresis YY/T 1805.3 Collagen for tissue engineering medical device products-Part 3.Collagen content based on characteristic peptide determination Quantitative Detection Liquid Chromatography-Mass Spectrometry Pharmacopoeia of the People's Republic of China

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Collagen collagen A class of secreted protein families containing at least 20 genetically distinct types, mainly serving as the structural support function of the body, with A unique triple helix configuration consisting of three polypeptide chains (called α chains) and has certain biological functions. ......

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