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YY/T 0953-2020Medical carboxymethyl chitosan (English PDF)

医用羧甲基壳聚糖

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 27, 2020

Implementation date

September 1, 2021

Scope

YY/T 0953-2020 is the English-translated version of 医用羧甲基壳聚糖.

YY/T 0953-2020 is the Chinese standard "Medical carboxymethyl chitosan".

Its scope clause reads: 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:. Its clauses include terms and definitions.

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Document preview — YY/T 0953-2020

National Standard of the People's Republic of China

ICS: 11.040.30
Classification: C 35
Replacing: YY/T 0953-2015

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for materials of animal origin
5 Technical requirements
6 Test method
7 Sign
8 Packaging, transportation and storage
Appendix A (informative appendix) Reference infrared spectrum of carboxymethyl chitosan
Appendix B (Normative Appendix) Determination of Deacetylation Degree and Substitution Degree of Carboxymethyl Chitosan
Appendix C (Normative Appendix) Determination of Isoelectric Point
Appendix E (Normative Appendix) Determination of Carboxymethyl Chitosan Content
Appendix F (Normative Appendix) Determination of Protein Content
Appendix G (Normative Appendix) Determination of Residual Ethanol (Gas Chromatography)
Appendix H (Normative Appendix) Determination of Residual Diglycolic Acid
Appendix I (Informative Appendix) Carboxymethyl Chitosan Degradation Test

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 beta(1 -> 4)

Linked linear polysaccharides: Its structural formula is:

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1699-2020|GB/T 38135-2019

Editions of YY/T 0953

Edition	Title	Revision	Status
YY/T 0953-2020	Medical carboxymethyl chitosan	current edition	Current
YY/T 0953-2015	Medical carboxymethyl chitosan	previous edition	Superseded

This page sells the current edition, YY/T 0953-2020. Earlier editions are listed for reference only.

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