YY/T 1699-2020Tissue engineering medical device products—Chitosan (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0606.7-2008 "Tissue Engineering Medical Products Part 7. Chitosan", and YY/T 0606.7-2008 In comparison, the main technical changes except for editorial changes are as follows.

--- The standard name was changed to "Tissue Engineering Medical Device Product Chitosan";

--- Deleted YY/T 16886 series normative references (only GB/T 16886.1, GB/T 16886.7 and GB/T 16886.12 (Reserved) (see Chapter 2, Chapter 2 of the 2008 edition);

--- Added normative reference documents YY/T 0771.1 ~ 0771.3 "Medical Devices of Animal Origin" (see Chapter 2);

--- Modified the normative references and the version year number of the "Pharmacopoeia of the People's Republic of China" (see Chapter 2, the 2008 edition of the Chapter 2);

--- Modified the classification (see Chapter 4, Chapter 4 of the 2008 edition);

--- Modified the requirements for materials of animal origin (see Chapter 5, Chapter 5 of the 2008 edition);

--- Modified the requirements for traits (see 6.1, 6.1 in the 2008 edition);

--- Added some main characteristic peaks of Fourier transform infrared spectrum (see 6.2, 6.2 in 2008 version);

--- Increased content requirements and test methods (see 6.3, 7.3 and Appendix A);

--- Modified the test method of the degree of deacetylation (see 7.4, 7.3 of the 2008 edition);

--- Modify the requirements and test methods of pH (see 6.5, 7.5, 6.4, 7.4 in 2008 edition);

--- Increased the molecular weight and distribution coefficient requirements and test methods (see 6.7, 7.7 and Appendix B);

--- Modified the test method of heavy metal content (see 7.8, 7.6 of 2008 edition and appendix A);

--- Modified the protein test method (see Appendix C, Appendix B of the 2008 edition);

--- Modify the requirements and test methods for the residual amount of ethanol (organic solvent) (see 6.10 and Appendix D, 6.8 and Appendix C of the 2008 edition);

--- Removed the ash requirements and test methods (2008 version 6.10, 7.10);

--- Increasing the requirements and test methods of ignition residue (see 6.12, 7.12);

--- Added requirements and test methods for arsenic salts (see 6.14, 7.14);

--- Modified the bacterial endotoxin limit requirements (see 6.15, 2008 version 6.12);

--- Modify the sterility test requirements and test methods (see 6.16, 7.16, 2008 version 6.13 and 7.13);

--- Added requirements and test methods for microbiological limits (see 6.17, 7.17);

--- Deleted the specific requirements and test methods of biological evaluation, and only retained the general rules (see 6.18, 7.18, 2008 version 6.14 and 7.14, 7.15);

--- Deleted Chapter 7 inspection rules (see Chapter 8 of the 2008 edition);

--- Deleted Appendix D background information (see the 2008 version of Appendix D);

--- Added references to "Guidelines for Registration and Application Information of Animal-derived Medical Device Products" and the European Pharmacopoeia (see References);

--- Revised the reference number ASTM F2103-01 version number (see References, 2008 version of the reference).

1 Scope

This standard specifies the requirements and test methods of chitosan and its salts used in the preparation of tissue engineering medical device products.

This standard applies to the preparation of chitosan and its salts for tissue engineering medical device products.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For the cited documents without date, the latest version (including all amendments) applies to this document.

GB/T 191 Graphic mark for packaging, storage and transportation

GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management

GB/T 16886.7 Biological evaluation of medical devices Part 1. Residue of ethylene oxide sterilization

GB/T 16886.12 Biological evaluation of medical devices Part 12. Sample preparation and reference samples

GB 18278.1 Damp heat of medical care products sterilization Part 1. Development, validation and routine control of medical device sterilization process Claim

GB 18279.1 Sterilization of ethylene oxide for healthcare products Part 1. Development, validation and routine control of medical device sterilization processes System requirements

GB 18280.1 Sterilization radiation for health care products Part 1. Development, validation and routine control of medical device sterilization process Claim

YY/T 0313 Packaging, marking, transportation and storage of medical polymer products

YY/T 0771.1 Medical Devices of Animal Origin Part 1 Risk Management Application

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 Four parts of the "Pharmacopoeia of the People's Republic of China" (2015 edition)

3 Terms and definitions

The following terms and definitions apply to this document.