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YY/T 1574-2017 English PDF

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YY/T 1574-2017: Tissue engineering medical device products - Standard guide for immobilization or encapsulation in alginate gels
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PDF similar to YY/T 1574-2017


Standard similar to YY/T 1574-2017

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1570   

Basic data

Standard ID YY/T 1574-2017 (YY/T1574-2017)
Description (Translated English) Tissue engineering medical device products - Standard guide for immobilization or encapsulation in alginate gels
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,170
Date of Issue 2017-08-18
Date of Implementation 2018-09-01
Issuing agency(ies) State Food and Drug Administration

YY/T 1574-2017: Tissue engineering medical device products - Standard guide for immobilization or encapsulation in alginate gels


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Tissue engineering medical device products-Standard guide for immobilization or encapsulation in alginate gels ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue engineering medical device products Guide to alginate gel immobilization or microencapsulation 2017-08-18 Posted 2018-09-01 implementation State Food and Drug Administration released Directory Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Meaning and purpose 2 5 alginate gel immobilization or microencapsulation 2 6 Performance of microcapsules or microbeads 5 7 Alginate gel biocompatibility 7 Appendix A (Normative) Preparation of alginate beads for immobilization or microencapsulation of living cells or tissues 8 Appendix B (Normative) Microcapsule morphology, size and distribution of particle size determination 9 Appendix C (Normative) Determination of microcapsule porosity 10 Appendix D (Normative) Diffusion of microcapsules Determination 11 Appendix E (Normative) Microcapsule drying determination 12 Appendix F (Normative) Determination of mechanical strength of microcapsules 13 References 14

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Organization Engineering Medical Devices Products Technical Committee (SAC/TC110/SC3) centralized. This standard was drafted. Huaqiao University, China Institute of Food and Drug Control. The main drafters of this standard. Wang Shibin, Feng Xiaoming, Xi Tingfei, Zhang Na, Liu Yuan Gang, Chen Aizheng, Ye Li, Tong Yuesheng. Tissue engineering medical device products Guide to alginate gel immobilization or microencapsulation

1 Scope

This standard specifies the alginate gel immobilization or microencapsulation evaluation requirements, including alginate gel immobilization or microencapsulation, microcapsules or Study on the Properties and Investigation of Micro-bead and the Biocompatibility of Alginate Gel. This standard applies to alginate gel immobilization or microencapsulation evaluation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 16352 disposable medical supplies γ-ray radiation sterilization standards GB 18278.1 health care products sterilization damp heat Part 1. Medical device sterilization process development, validation and general control requirements GB 18281 (all parts) Sterilization bio-indicators for healthcare products [ISO 11138 (all parts)] Biological evaluation of medical devices - Part 4. Choice of tests for interaction with blood (ISO 10993..2004). 2002, IDT) GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993.5.1999, IDT) GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity test (ISO 10993.11-2006, IDT) Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (ISO 10993.12. 2002, IDT) YY/T 0606.8 Tissue engineering medical products - Part 8. Sodium alginate Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Alginate alginate A polysaccharide extracted from common seaweed that forms insoluble mixtures with calcium, magnesium, sodium or potassium salts. Alginate comes from In brown algae, which is the most abundant polysaccharide in brown algae, it is mainly found in the cell walls and intercellular spaces of seaweed and seaweed, and its main function is Maintain seaweed strength and toughness. Alginates can be classified as hydrocolloids. The most commonly used alginate is sodium alginate. 3.2 APA microcapsules APAbead Alginate-poly-L-lysine-alginate microbeads.

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