GB/T 38135-2019Chitosan staple fibers for medical applications (English PDF)

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.