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GB/T 38135-2019 English PDF

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GB/T 38135-2019: Chitosan staple fibers for medical applications
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB/T 38135-2019	English	359	Add to Cart	4 days [Need to translate]	Chitosan staple fibers for medical applications	Valid	GB/T 38135-2019

PDF similar to GB/T 38135-2019

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Basic data

Standard ID	GB/T 38135-2019 (GB/T38135-2019)
Description (Translated English)	Chitosan staple fibers for medical applications
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	W52
Classification of International Standard	59.060.20
Word Count Estimation	18,163
Date of Issue	2019-10-18
Date of Implementation	2020-05-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration

GB/T 38135-2019: Chitosan staple fibers for medical applications

---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.
Chitosan staple fibers for medical applications ICS 59.060.20 W52 National Standards of People's Republic of China Medical chitosan staple fiber Published on.2019-10-18 2020-05-01 implementation State market supervision and administration China National Standardization Administration issued

Content

Foreword III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Product specifications and logo 2 5 Technical requirements 2 6 Test method 4 7 Inspection rules 5 8 Marking, packaging, transportation and storage 6 Appendix A (Normative Appendix) Determination of Acid Insolubles 7 Appendix B (Normative) Determination of protein content 9 Appendix C (Normative) Determination of Ethanol Residues (Gas Chromatography) 12

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard is proposed and managed by the China National Textile and Apparel Council. This standard was drafted. Hais Moore Biotechnology Co., Ltd., China Food and Drug Control Institute, Shanghai Textile Industry Technology Supervision Supervisory Office, Beijing Medical Device Inspection Institute. The main drafters of this standard. Hu Guangmin, Zhou Jiacun, Lin Liang, Wei Lina, Wang Lili, Wang Lixia, Lin Hongsai, Zhang Juan, Du Yantao, Chen Kai. Medical chitosan staple fiber

1 Scope

This standard specifies the product specifications and markings, technical requirements, test methods, inspection rules, and signs and packages of medical chitosan staple fibers. Requirements for loading, transport and storage. This standard applies to natural chitosan short fibers produced from chitosan.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon Textiles and textiles - Performance and test terms - Part 1. Fibers and yarns GB/T 3291.3 Textiles and textile materials - Performance and test terms - Part 3 GB/T 4146 (all parts) textile chemical fiber GB/T 6503 chemical fiber moisture regain test method GB/T 6682 Analytical laboratory water specifications and test methods GB/T 7573-2009 Determination of pH value of textile water extracts GB/T 14233.1-2008 Methods of test for infusions, blood trans GB/T 14334 chemical fiber short fiber sampling method GB/T 14335-2008 Chemical fiber staple fiber linear density test method GB/T 14336 chemical fiber short fiber length test method GB/T 14337 Test method for tensile properties of chemical fiber staple fibers GB/T 14339-2008 Chemical fiber short fiber defect test method GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials FZ/T 50037 chitosan fiber deacetylation test method YY/T 0313 Requirements for information provided by medical polymer product packaging and manufacturers YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements YY/T 0771.2 Animal source medical devices - Part 2. Controls of source, collection and treatment YY/T 0771.3 Animal source medical devices - Part 3. Removal and inactivation of viral and disseminated spongiform encephalopathy (TSE) confirm Pharmacopoeia of the People's Republic of China (2015 edition four)

3 Terms and definitions

The following terms and definitions are defined in GB/T 3291.1, GB/T 3291.3, GB/T 4146 (all parts) and FZ/T 50037. Used in this document. For ease of use, some of the terms and definitions in GB/T 4146.3 are repeated below.

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