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YY/T 1571-2017 PDF English

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YY/T 1571-2017: Tissue engineering medical device products - Sodium hyaluronate
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YY/T 1571-2017: Tissue engineering medical device products - Sodium hyaluronate

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.40 C 45 Replacing YY/T 0606.9-2007 Tissue engineering medical device products - Sodium hyaluronate Issued on. MAY 02, 2017 Implemented on. APRIL 01, 2018 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 7 4 Classification... 7 5 Requirements... 8 6 Test methods... 10 7 Marking... 14 8 Packaging, transportation and storage... 15 Appendix A (Normative) Determination of sodium hyaluronate content... 16 Appendix B (Normative) Determination of protein content... 19 Appendix C (Normative) Determination of residual ethanol (headspace gas chromatography)... 21 Appendix D (Informative) Determination of residual quaternary ammonium salt (cetylpyridinium chloride)... 23 Appendix E (Normative) Determination of weight-average molecular weight and molecular weight distribution coefficient... 26 References... 28

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard replaces YY/T 0606.9-2007, Tissue engineered medical products - Part 9.Sodium hyaluronate. Compared with YY/T 0606.9-2007, the major technical changes are as follows. -- Change the standard name to Tissue engineering medical device products - Sodium hyaluronate; -- Delete the normative references of YY/T16886 series (only reserve YY/T 16886.1) (see Chapter 2; Chapter 2 of the 2007 edition); -- Add the normative references YY/T 0771.1 ~ 0771.3, Medical devices utilizing animal tissues and their derivatives (see Chapter 2); -- Revise the edition year number of “Pharmacopeia of the People’s Republic of China” in the normative references (see Chapter 2; Chapter 2 of the 2007 edition); -- Modify the molecular formula (structural unit) of sodium hyaluronate (see 3.2; 3.2 of the 2007 edition); -- Modify the requirements and test methods for sodium hyaluronate content (see 5.3, 6.3 and Appendix A; 5.3, 6.3 and Appendix A of the 2007 edition); -- Modify the requirements for intrinsic viscosity and the molecular weight symbol M in the formula of the test method (see 5.5, 6.5; 5.5, 6.5 of the 2007 edition); -- Delete the requirements and test methods for dynamic viscosity (see 5.6 and 6.6 of the 2007 edition); -- Modify the test method for protein content (see 6.6 and Appendix B; 6.7 and Appendix B of the 2007 edition); -- Add the requirements and test methods for nucleic acids (see 5.7 and 6.7); -- Modify the test method for heavy metal content (see 6.8; 6.8 of the 2007 edition); -- Modify the requirements and test methods for residual ethanol (see 5.9, 6.9 and Appendix C; 5.9, 6.9 and Appendix C of the 2007 edition); -- Delete the requirements and test methods for ash content (see 5.11 and 6.11 of the 2007 edition); -- Delete the requirements and test methods for ultraviolet absorption (see 5.12 and 6.12 of the 2007 edition); -- Modify the requirements and test methods for dry matter content (see 5.10, 6.10; 5.10, 6.10 of the 2007 edition); -- Add the requirements and test methods for quaternary ammonium salt residues (see 5.11, 6.11 and Appendix D); -- Add the requirements and test methods for sulfated mucopolysaccharides (see 5.12 and 6.12); -- Add the requirements and test methods for iron content (see 5.13 and 6.13); -- Add the requirements and test methods for chlorides (see 5.14 and 6.14); -- Add the requirements and test methods for weight-average molecular weight and molecular weight distribution coefficient (see 5.15, 6.15 and Appendix E); -- Add the requirements and test methods for the clarity and color of solution (see 5.16 and 6.16); -- Add the requirements and test methods for microbial limit (see 5.18, 6.18); -- Modify the requirements and test methods for bacterial endotoxin limit (see 5.19, 6.19; 5.14, 6.14 of the 2007 edition); -- Modify the requirements and test methods for raw material safety (see 5.20, 6.20, 6.21; 5.15, 6.15 of the 2007 edition); -- Delete the specific requirements and test methods for biological evaluation, only retaining the general principles (see 5.21; 5.16 and 6.16 of the 2007 edition); -- Delete Chapter 7 Inspection rules (see Chapter 7 of the 2007 edition); -- Delete the background information of Appendix D (see Appendix D of the 2007 edition); -- Add the references “Guiding Principles for Registration and Declaration of Medical Device Products Utilizing Animal Tissues and Their Derivatives” and European Pharmacopoeia (see References); -- Modify the version number of the reference ASTM F2347-03 (see References; References of the 2007 edition). 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 was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of Subcommittee on Tissue Engineering Medical Device Products of National Technical Committee 110 on Implants for Surgery and Orthopedic Devices of Standardization Administration of China. Drafting organizations of this Standard. Bloomage Biotechnology Corporation Limited, National Institute for Food and Drug Control, Shanghai Qisheng Biological Preparation Co., Ltd. Main drafters of this Standard. Guo Xueping, Mu Shu’e, Jiang Lixia, Xu Liming, Wei Changzheng, Wang Xiujuan, Shao Anliang. The previous version replaced by this Standard is. -- YY/T 0606.9-2007. Tissue engineering medical device products - Sodium hyaluronate

1 Scope

This Standard specifies the requirements and test methods for sodium hyaluronate used in surgical implants and tissue engineering medical device products. This Standard applies to the preparation of sodium hyaluronate for tissue engineering medical device products and their scaffold materials.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies to this document. For undated references, the latest edition (including any amendment) applies to this document. GB/T 191, Packaging - Pictorial marking for handling of goods GB/T 14518, Determination of the pH of adhesives GB/T 16886.1, Biological evaluation of medical devices - Part 1.Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1.2009, IDT) GB 18278 (all parts), Sterilization of health care products - Moist heat GB 18279 (all parts), Sterilization of health care products - Ethylene oxide GB 18280 (all parts), Sterilization of health care products - Radiation YY/T 0313, Medical polymer products - Requirement for package and information supplied by manufacturer YY/T 0606.25, Tissue engineered medical product - Part 25.Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives. Fluorescence method YY/T 0771.1, Medical devices utilizing animal tissues and their derivatives - Part 1. Application of risk management (YY/T 0771.1-2009, ISO 22442-1.2007, IDT) YY/T 0771.2, Medical devices utilizing animal tissues and their derivatives - Part 2. Controls on sourcing, collection and handling (YY/T 0771.2-2009, ISO 22442- 2.2007, IDT)

3 Terms and definitions

The following terms and definitions are applicable to this document. 3.1 Hyaluronic acid A linear polysaccharide that is composed of disaccharide repeating structural units of D-glucuronic acid and N-acetyl-D-glucosamine linked by β-(1-3) glycosidic bonds. Each disaccharide unit is linked to the other by a β-(1-4) glycosidic bond.

4 Classification

The preparation process of sodium hyaluronate can be divided into tissue extraction method and bacterial fermentation method according to different raw material sources and preparation methods.

5 Requirements

5.1 Appearance White or off-white powder or granular or fibrous solid, without any visible foreign matter. 5.3 Sodium hyaluronate content Based on the dry product, the content of sodium hyaluronate shall be 95.0% ~ 105.0% (mass fraction). 5.4 pH The pH of the 0.5% concentration solution shall be 5.0 ~ 8.5. 5.5 Intrinsic viscosity It shall be 90% ~ 120% of its marked value. 5.6 Protein content It shall not exceed 0.1% (mass fraction). 5.7 Nucleic acid content 5.8 Heavy metal content It shall not exceed 10 μg/g (mass fraction). 5.9 Residual amount of ethanol It shall not exceed 4 000 μg/g (mass fraction). 5.13 Iron content It shall not exceed 80 μg/g. 5.14 Chlorine content It shall not exceed 0.5%. 5.15 Weight-average molecular weight and molecular weight distribution coefficient The weight-average molecular weight of sodium hyaluronate shall be within the range indicated by the manufacturer, and the distribution coefficient 𝑀ௐതതതതത/𝑀௡തതതത shall be 1.0 ~ 3.0. 5.18 Microbiological examination The number of bacterial colonies per 1 g of the test product shall not exceed 102 CFU; the number of mold and yeast colonies shall not exceed 20 CFU. Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli shall not be detected. 5.19 Bacterial endotoxins The amount of endotoxin contained per 1 mg of sodium hyaluronate shall be less than 0.05 EU. 5.20 Raw material safety

6 Test methods

6.1 Appearance Perform direct observation with the naked eye, which shall comply with the provisions of 5.1. 6.3 Determination of sodium hyaluronate content Measure according to the method specified in Appendix A, which shall comply with the provisions of 5.3. 6.4 pH determination Use distilled water to prepare sodium hyaluronate (based on the dry product) to a solution of concentration 5 mg/mL; measure according to the method specified in GB/T 14518, which shall meet the requirements of 5.4. 6.6 Determination of protein content Measure according to the method specified in Appendix B, which shall comply with the provisions of 5.6. 6.7 Determination of nucleic acid Take this product (equivalent to 0.10 g of dry product); add 30 mL of 0.9% sodium chloride solution; oscillate to mix and dissolve it as the test solution. 6.8 Determination of heavy metal content Take 1.0 g of this product; measure it according to method II stipulated in the general rule 0821 of Pharmacopoeia of the People’s Republic of China (2015 Edition, Volume IV), which shall meet the requirements of 5.8. 6.11 Determination of quaternary ammonium residues Measure by referring to the method specified in Appendix D, which shall comply with the provisions of 5.11. 6.12 Determination of sulfated mucopolysaccharides Test solution. Take about 50.0 mg of this product (based on the dry product); add 1.0 mL of perchloric acid to a stoppered test tube (length is 5 cm; inner diameter is 1.6 cm); dissolve it; use it as the test solution. 6.13 Determination of iron content Take 0.25 g of this product (based on the dry product); add 1.0 mL of nitric acid; heat it in a water bath to dissolve; prepare 5 portions in parallel; after cooling, add water to one part to dilute to 10 mL as the test solution, and add 0.5 mL, 1.0 mL, 1.5 mL and 2.0 mL of iron standard solution (each 1.0 mL is equivalent to 10 μg/mL iron) to the other 4 portions, respectively; 6.16 Determination of clarity and color of solution Take 0.10 g of this product (based on the dry product); add 30 mL of 0.9% sodium chloride solution; shake to mix and dissolve, which shall meet the requirements of 5.16. 6.17 Sterility test Measure according to the method specified in the general rule 1101 of Pharmacopoeia of the People’s Republic of China (2015 Edition, Volume IV), which shall meet the requirements of 5.17. 6.18 Microbial limits Take 5.0 g of this product; add 100 mL of sterile phosphate buffered saline (pH 7.2) containing 45 000 units of hyaluronidase; shake and dissolve in a water bath at 42 °C for 1 h, to obtain a 1.20 test solution. Measure according to the method specified in the general rules 1105 and 1106 of Pharmacopoeia of the People’s Republic of China (2015 Edition, Volume IV), which shall meet the requirements of 5.18.

7 Marking

7.1 The outer package shall have the following markings. 7.2 The small package shall have the following markings. 7.3 The storage marking shall comply with the provisions given in GB/T 191. Note. Refer to the graphic symbols given in YY 0466.1, which shall meet the above requirements.

8 Packaging, transportation and storage

8.1 Packaging shall be appropriate, to ensure the safety and effectiveness of sodium hyaluronate products. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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