Standards and quality control points of alginate-based medical devices_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

REN Ying ¹ ,  ZHANG Demeng ²

1. Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100081, P.R.China;
2. State Key Laboratory of Seaweed Bioactive Substances, Qingdao Shandong, 266400, P.R.China;

Corresponding?author：

ZHANG Demeng, Email: zdm@bmsg.com

Keywords：

Alginate; medical device; product standard; quality control

DOI：

10.7507/1002-1892.201812002

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about.Methods Based on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed.Results With the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards.Conclusion Considering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.

Citation： REN Ying, ZHANG Demeng. Standards and quality control points of alginate-based medical devices. Chinese Journal of Reparative and Reconstructive Surgery, 2019, 33(8): 1041-1044. doi: 10.7507/1002-1892.201812002 Copy

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21.	國家食品藥品監督管理總局. 無源植入性醫療器械貨架有效期注冊申報資料指導原則(2017年修訂版)[EB/OL]. (2017-05-12) [2019-06-13] http://samr.cfda.gov.cn/WS01/CL0087/173182.html.

1. 位曉娟, 奚廷斐, 顧其勝, 等. 醫用海藻酸基生物材料的研究進展. 中國修復重建外科雜志, 2013, 27(8): 1015-1020.
2. Augst AD, Kong HJ, Mooney DJ. Alginate hydrogels as biomaterials. Macromol Biosci, 2006, 6(8): 623-633.
3. Lee KY, Mooney DJ. Alginate: properties and biomedical applications. Prog Polym Sci, 2012, 37(1): 106-126.
4. Sun JY, Zhao X, Illeperuma WR, et al. Highly stretchable and tough hydrogels. Nature, 2012, 489(7414): 133-136.
5. Lin ZF, Wu MM, He HM, et al. 3D Printing of Mechanically stable calcium-free alginate based scaffolds with tunable surface charge to enable cell adhesion and facile biofunctionalization. Advanced Functional Materials, 2019, 29(9): 1808439.
6. Wei Z, Yang JH, Liu ZQ, et al. Novel biocompatible polysaccharide-based self-healing hydrogel. Advanced Functional Materials, 2015, 25(9): 1352-1359.
7. Aderibigbe BA, Buyana B. Alginate in wound dressings. Pharmaceutics, 2018, 10(42): 1-19.
8. The United States Pharmacopeial Convention. United States Pharmacopeia 39/ National Formulary 34. Maryland: United States Pharmacopeial Convention, 2016: 7514-7515.
9. European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia. 8th ed. Strasbourg: EDQM, 2013: 3226.
10. 國家藥典委員會. 中華人民共和國藥典 (2015 年版) 四部. 北京: 中國醫藥科技出版社, 2015: 554-555.
11. 顧其勝, 周則紅, 關心. 醫用海藻酸鹽產品標準與質量控制. 中國修復重建外科雜志, 2013, 27(6): 760-764.
12. American Society for Testing and Materials. ASTM F2064-17 standard guide for characterization and testing of alginates as starting materials intended for use in biomedical and tissue-engineered medical products application. Pennsylvania: ASTM International, 2017: 1-9.
13. 國家食品藥品監督管理局. 中華人民共和國醫藥行業標準組織工程醫療產品第8部分: 海藻酸鈉 YY/T 0606.8-2008. 北京: 中國標準出版社, 2008: 1-14.
14. 國家藥品監督管理局. 中華人民共和國醫藥行業標準齒科藻酸鹽印模材料 YY 1027-2001. 北京: 中國標準出版社, 2001: 1-11.
15. 國家食品藥品監督管理總局. 中華人民共和國醫藥行業標準接觸性創面敷料 YY/T 1293.5-2017. 北京: 中國標準出版社, 2017: 1-6.
16. 顧其勝, 王帥帥, 王慶生, 等. 海藻酸鹽敷料應用現狀與研究進展. 中國修復重建外科雜志, 2014, 28(2): 255-258.
17. 國家食品藥品監督管理總局. 中華人民共和國醫藥行業標準組織工程醫療器械產品海藻酸鹽凝膠固定或微囊化指南 YY/T 1574-2017. 北京: 中國標準出版社, 2017: 1-15.
18. 國家質量監督檢驗檢疫總局. 中華人民共和國國家標準醫療器械生物學評價第7部分: 環氧乙烷滅菌殘留量GB/T 16886.7-2015. 北京: 中國標準出版社, 2016: 105-132.
19. 國家藥品監督管理局. 除菌過濾技術及應用指南[EB/OL]. (2018-09-11) [2019-06-13] http://www.nmpa.gov.cn/WS04/CL2183/330190.html.
20. 顧其勝, 王慶生, 位曉娟, 等. 海藻酸鹽基生物醫用材料與臨床醫學. 上海: 上海科學技術出版社, 2015: 8-35.
21. 國家食品藥品監督管理總局. 無源植入性醫療器械貨架有效期注冊申報資料指導原則(2017年修訂版)[EB/OL]. (2017-05-12) [2019-06-13] http://samr.cfda.gov.cn/WS01/CL0087/173182.html.

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Standards and quality control points of alginate-based medical devices

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