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YY/T 0953-2020: Medical carboxymethyl chitosan
Status: Valid YY/T 0953: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0953-2020 | English | 409 |
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Medical carboxymethyl chitosan
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YY/T 0953-2020
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| YY 0953-2015 | English | 919 |
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[YY/T 0953-2015, including 2019XG1] Medical carboxymethylchitosan
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YY 0953-2015
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| YY/T 0953-2015 | English | 959 |
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(Medical carboxymethyl chitosan)
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YY/T 0953-2015
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PDF similar to YY/T 0953-2020
Basic data | Standard ID | YY/T 0953-2020 (YY/T0953-2020) | | Description (Translated English) | Medical carboxymethyl chitosan | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 22,230 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Older Standard (superseded by this standard) | YY/T 0953-2015 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 0953-2020: Medical carboxymethyl chitosan---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.
(Medical carboxymethyl chitosan)
ICS 11:040:30
C35
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0953-2015
Medical carboxymethyl chitosan
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements for materials of animal origin 2
5 Technical requirements 2
6 Test method 4
7 Sign 6
8 Packaging, transportation and storage 6
Appendix A (informative appendix) Reference infrared spectrum of carboxymethyl chitosan 7
Appendix B (Normative Appendix) Determination of Deacetylation Degree and Substitution Degree of Carboxymethyl Chitosan 8
Appendix C (Normative Appendix) Determination of Isoelectric Point 10
Appendix D (Normative Appendix) Determination of Weight Average Molecular Mass and Molecular Mass Distribution Coefficient 11
Appendix E (Normative Appendix) Determination of Carboxymethyl Chitosan Content 12
Appendix F (Normative Appendix) Determination of Protein Content 13
Appendix G (Normative Appendix) Determination of Residual Ethanol (Gas Chromatography) 15
Appendix H (Normative Appendix) Determination of Residual Diglycolic Acid 16
Appendix I (Informative Appendix) Carboxymethyl Chitosan Degradation Test 18
Reference 19
Foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
This standard replaces YY/T 0953-2015 "Medical Carboxymethyl Chitosan", compared with YY/T 0953-2015, except for editorial changes
The main technical changes are as follows:
--- Delete the inspection rules in the scope (see Chapter 1, Chapter 1 of the:2015 edition);
---Modified the normative reference documents and the edition year number of the Pharmacopoeia of the People's Republic of China (see Chapter 2,:2015 edition
chapter 2);
---Modified the definition of carboxymethyl chitin and carboxymethyl chitosan (see 3:3 and 3:4, 3:3 and 3:4 in the:2015 edition);
---Modified appearance requirements and test methods (see 5:1 and 6:1, 5:1 and 6:1 of the:2015 edition);
---Modified some of the absorption peaks of the Fourier transform infrared spectrum (see 5:2, 5:2 in the:2015 edition);
---Modified the test method of degree of substitution (degree of carboxylation) (see Appendix B, Appendix C of the:2015 edition);
---Added the requirements and test methods for the degree of deacetylation (see 5:4, 6:4 and Appendix B);
---Modified the requirements and test methods of isoelectric point (see 5:5, Appendix C, 5:4, Appendix H of the:2015 edition);
---Modified the requirements for loss on drying (see 5:6, 5:5 in the:2015 edition);
---Modified pH requirements and test methods (see 5:7, 6:7, 5:6, 6:6 of the:2015 edition);
---Modified the requirements for protein content (see 5:12, 5:11 of the:2015 edition);
---Modified the requirements and test methods of residue on ignition (see 5:14 and 6:14, 5:13 and 6:13 in the:2015 edition);
---Modified the requirements and test methods of insoluble matter (see 5:15 and 6:15, 5:14 and 6:14 of the:2015 edition);
---Modified the test method of ethanol residue (see Appendix G, Appendix F of the:2015 edition);
---Modified the requirements of microbial limit (see 5:17:2, 5:16:2 of the:2015 edition);
---Modified the limit requirements for bacterial endotoxin inspection (see 5:18, 5:17 in the:2015 edition);
---Deleted the specific requirements and test methods for biological evaluation (see 5:19, 6:19, 5:18 and 6:18 of the:2015 edition);
---The inspection rules are deleted (see Chapter 7 of the:2015 edition);
--- "Recommended to use the graphical symbols given in YY/T 0466:1" moved from the note to the text (see 7:2,:2015 edition 8:1:2):
Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is organized by the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices, and the Sub-Technical Committee for Medical Device Products
(SAC/TC110/SC3) Centralized:
Drafting organizations of this standard: China Institute for Food and Drug Control, School of Materials Science and Engineering, South China University of Technology, Shanghai Qisheng Biological System
Co:, Ltd:, Shijiazhuang Yishengtang Medical Products Co:, Ltd:, Yantai Wanli Medical Products Co:, Ltd:, Qingdao Boyite Biological Materials Co:, Ltd:
Company, Sykes Biotechnology Co:, Ltd:, Beijing Bailikang Biochemical Co:, Ltd:, Hangzhou Xiehe Medical Products Co:, Ltd:, Sichuan Province
Food and Drug Inspection and Testing Institute, Fujian Jiterui Biological Technology Co:, Ltd:
The main drafters of this standard: Fu Bufang, Du Chang, Jiang Lixia, Li Suzhe, Zhang Hexin, Jiang Huiping, Gao Weiwei, Shi Bo, Shi Jiali, Liu Xinglan,
Zhang Qiqing:
The previous releases of this standard are as follows:
---YY/T 0953-2015:
Medical carboxymethyl chitosan
1 Scope
This standard specifies the requirements, test methods, packaging, transportation and storage of raw materials for medical carboxymethyl chitosan:
This standard applies to the use of chitosan or chitin as raw materials, through deacetylation, carboxylation, and purification for the manufacture of tissue engineering medical devices
Medical products of medical carboxymethyl chitosan:
Note: This standard can be referred to when carboxymethyl chitosan is used as a raw material for other medical device products:
2 Normative references
The following documents are indispensable for the application of this document: For dated reference documents, only the dated version applies to this article
Pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191 Packaging, Storage and Transportation Graphic Mark
GB/T 14233:1 Medical infusion, blood transfusion, and injection equipment inspection methods Part 1: Chemical analysis methods
GB/T 16886:1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in the Process of Risk Management
GB/T 16886:17 Biological Evaluation of Medical Devices Part 17: Establishment of Allowable Limits for Leachables
YY/T 0313 Medical polymer product packaging and information requirements provided by manufacturers
YY/T 0466:1 Medical devices are used for medical device labeling, marking and information symbols: Part 1: General requirements
YY/T 0771:1 Medical devices of animal origin Part 1: Risk management applications
YY/T 0771:2 Medical devices of animal origin Part 2: Control of source, collection and disposal
YY/T 0771:3 Medical devices of animal origin Part 3: Virus and transmissible spongiform encephalopathy (TSE) factor removal and inactivation
confirm
Pharmacopoeia of the People's Republic of China (2015 edition four)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Chitosan
From 2-amino-2-deoxy-D-glucopyranose (GlcN) and 2-acetylamino-2-deoxy-D-glucopyranose (GlcNAc) through β(1 → 4)
Linked linear polysaccharides: Its structural formula is:
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