YY/T 1577-2017Tissue engineering medical device products - Standard guide for microstructure of polymeric scaffolds (English PDF)
组织工程医疗器械产品聚合物支架微结构评价指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
August 18, 2017
Implementation date
September 1, 2018
Scope
YY/T 1577-2017 is the English-translated version of 组织工程医疗器械产品聚合物支架微结构评价指南.
YY/T 1577-2017 is the Chinese pharmaceutical industry standard that guides the evaluation of the microstructure of porous polymeric scaffolds for tissue engineering products.
It sets out the properties to be characterised - pore size and its distribution, porosity, interconnectivity and permeability - and the test methods available for each, so that a scaffold can be described in numbers that mean the same from one laboratory to another. Issued on 18 August 2017, it has applied since 1 September 2018.
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Document preview — YY/T 1577-2017
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Summary
- 5 Meaning and purpose
- 6 imaging
- 7 Physical Characterization
- 8 Performance Evaluation
- Appendix A (informative) organizational performance requirements of the stent
- Appendix B (informative) Classification of aperture Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
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
The void in the solid does not have any connectivity with the outer surface.
3.4 Hydrogel
An open, aqueous network formed by chemical or physical crosslinking of polymer chains.
3.5 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
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Related Standards
YY/T 0606.5-2007 — Tissue Engineered Medical Products - Part 5: Characterization and Testing of Substrates and Scaffolds
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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