YY/T 1888-2023 English PDF

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YY/T 1888-2023: Calibration Specification for Half-value Layer Meters of(20~150)kV X-ray beam
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1888-2023	379	Add to Cart	4 days	Calibration Specification for Half-value Layer Meters of(20~150)kV X-ray beam	Valid

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Basic data

Standard ID: YY/T 1888-2023 (YY/T1888-2023)
Description (Translated English): Calibration Specification for Half-value Layer Meters of(20~150)kV X-ray beam
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 18,171
Date of Issue: 2023-01-18
Date of Implementation: 2023-07-20
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the quality control, technical requirements, test methods, stability, biological evaluation, packaging, transportation and storage of recombinant humanized collagen. This standard applies to the quality control of recombinant humanized collagen that does not contain the amino acid sequence of non-human collagen as raw materials for medical devices.

YY/T 1888-2023: Calibration Specification for Half-value Layer Meters of(20~150)kV X-ray beam

---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 CCSC30 Pharmaceutical Industry Standard of the People's Republic of China Recombinant Humanized Collagen Released on 2023-01-18 2023-07-20 Implementation Released by the State Drug Administration

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. Please note that some contents of this document may refer to patents. Publishing of this document The Agency assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the Medical Device Technology Evaluation Center of the State Food and Drug Administration. This document was drafted by. Fudan University, Sichuan University, Institute of Biophysics, Chinese Academy of Sciences, Second Affiliated Hospital of Chongqing Medical University, Sichuan Medical Device Biomaterials and Products Inspection Center Co., Ltd. (Sichuan Medical Devices Biomaterials and Products Inspection Center), Shaanxi Provincial Food Institute for Drug Control, Shandong Institute for Medical Device and Drug Packaging Inspection, Sichuan Institute for Drug Control (Sichuan Medical Device Testing Center), Shanxi Jinbo Biomedicine Co., Ltd., Jiangsu Chuangjian Medical Technology Co., Ltd., Shanghai Zhongke New Life Biology Co., Ltd. Technology Co., Ltd. The main drafters of this document. Lu Lu, Wang Yunbing, Zhu Yun, Yang Li, Lin Hai, Dong Xiaojing, Liang Jie, Cai Hu, Zhang Min, Liu Xinglan, Wang Jian, Li Haihang, Ruan Hongqiang, Jiang Shibo, Deng Xiang, Wang Changhe, Hou Li, Zhao Daiguo, Yu Yufeng, Fan Xiaoju, Liu Jingtang, Hua Chen. Recombinant Humanized Collagen

1 Scope

This document specifies the quality control, technical requirements, test methods, stability, biological evaluation and packaging of recombinant humanized collagen. Packing, transportation and storage etc. This document applies to the quality of recombinant humanized collagen that does not contain the amino acid sequence of non-human collagen as a raw material for medical devices control. NOTE. The samples validated in this document are based on recombinant type III humanized collagen raw material. Other recombinant humanized collagen raw materials, if applicable, can be referred to Exam document.

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 YY/T 1849-2022 Recombinant Collagen Pharmacopoeia of the People's Republic of China

3 Terms and Definitions

YY/T 1849-2022 and the following terms and definitions apply to this document. 3.1 The full-length or partial amino acid sequence fragments encoded by human collagen-specific type genes prepared by DNA recombinant technology, or human collagen-containing A combination of functional fragments of collagen. 3.2 Human collagen types humancolagentypes Genetically, it can be divided into more than 20 different species, which differ in amino acid sequence, molecular assembly form or tissue distribution characteristics. Note. Different types of human collagen are generally named sequentially by Roman numerals, such as humanTypeⅠcolagen means human typeⅠcollagen. each type Human collagen is assembled by one or more collagen genes, for example, human type Ⅰ collagen is composed of human COL1A1 and COL1A2 genes coded assembly. 3.3 human collagen fragment humancolagenfragment It is an amino acid sequence fragment with a certain continuous length that can form a stable structure within the same amino acid sequence of human collagen.

4 Quality Control

Due to the different human collagen types and amino acid sequence fragments selected for recombinant humanized collagen, and the differences in expression systems, the amino acid sequence and physical and chemical properties are quite different. Used as raw materials for medical devices, it is necessary to establish a suitable method for quality control of products between different batches. ......

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