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YY/T 1577-2017 English PDF

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YY/T 1577-2017: Tissue engineering medical device products - Standard guide for microstructure of polymeric scafforlds
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PDF similar to YY/T 1577-2017


Standard similar to YY/T 1577-2017

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

Basic data

Standard ID YY/T 1577-2017 (YY/T1577-2017)
Description (Translated English) Tissue engineering medical device products - Standard guide for microstructure of polymeric scafforlds
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 18,116
Date of Issue 2017-08-18
Date of Implementation 2018-09-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 99
Issuing agency(ies) State Food and Drug Administration

YY/T 1577-2017: Tissue engineering medical device products - Standard guide for microstructure of polymeric scafforlds


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Tissue engineering medical device products-Standard guide for microstructure of polymeric scafforlds ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue engineering medical device products Polymer scaffolds - Microstructural evaluation guidelines 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 Summary 3 5 Meaning and purpose 3 6 imaging 5 7 Physical Characterization 8 8 Performance Evaluation 9 Appendix A (informative) organizational performance requirements of the stent 11 Appendix B (informative) Classification of aperture 12 Reference 13

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 Focused. This standard was drafted. China Food and Drug Control Research Institute. The main drafters of this standard. Chen Liang, Shao Anliang, Zhang Na, Wang Chunren. Tissue engineering medical device products Polymer scaffolds - Microstructural evaluation guidelines

1 Scope

This standard gives a method for the evaluation of porous polymeric scaffolds for tissue engineering medical products, including evaluation of pore size, pore size Distribution, porosity, connectivity, and permeability and other performance indicators available test methods guide. This standard applies to polymer stent micro junction Structure evaluation. Note. These indicators are important for optimizing the material structure for a given application, for developing an effective manufacturing process route, and for providing reliable quality control parameters.

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. YY/T 0606.5-2007 Tissue engineering medical products Part 5. The matrix and scaffold performance and testing

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Bioactiveagent bioactiveagent Any element in the device that contains or is filled within the instrument surface that induces the desired tissue or cellular response. Note. Growth factors, antibiotics, etc. are all typical bioactive factors. Device components that induce local limited biological activity or degradation by-products do not belong Bioactive factor. 3.2 Blind (end) hole blind (end) -pore Apertures that communicate with the outer surface or the outer pass-through inner surface only through an orifice whose diameter is less than its depth. Note. Schematic diagram shown in Figure 2b). 3.3 Closed-hole closedcel/closedpore The void in the solid does not have any connectivity with the outer surface. 3.4 Hydrogel hydrogel An open, aqueous network formed by chemical or physical crosslinking of polymer chains. 3.5 Macropore macropore Pores larger than 100 μm (including void space). Note. General naked eye observation. Macropores allow free passage of chemicals, biomolecules, viruses, bacteria and mammalian cells. For intercommunication Pore implants, macropores provide room for tissue to grow easily and microvascularly after implantation.

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