YY/T 1616-2018Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds (English PDF)
组织工程医疗器械产品 生物材料支架的性能和测试指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 7, 2018
Implementation date
November 1, 2019
Scope
YY/T 1616-2018 is the English-translated version of 组织工程医疗器械产品 生物材料支架的性能和测试指南.
YY/T 1616-2018 is the Chinese standard "Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds". Its scope clause reads: This standard gives the chemical properties and test methods, physical properties and test methods, mechanical properties and test methods of biomaterial scaffolds.
Biological testing and evaluation, degradation performance and testing, sterilization, quality assurance, etc. This standard applies to the performance evaluation of biomaterial scaffolds for the preparation of tissue engineering medical device products.
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Document preview — YY/T 1616-2018
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
- Replacing
- YY/T 0606.5-2007
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 stent chemistry and test methods
- 5 stent physical properties and test methods
- 6 Bracket mechanical properties and test methods
- 7 Biological tests and evaluations
- 8 stent degradation performance and test
- 9 Sterilization
- 10 Quality Assurance
- Appendix A (informative) Characterization of scaffold porosity
- Appendix B (informative) Supplemental scaffold material properties and testing
1 Scope
This standard gives the chemical properties and test methods, physical properties and test methods, mechanical properties and test methods of biomaterial scaffolds.
Biological testing and evaluation, degradation performance and testing, sterilization, quality assurance, etc.
This standard applies to the performance evaluation of biomaterial scaffolds for the preparation of tissue engineering medical device products.
2 Normative references
The following documents are indispensable for the application of this document. 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/T 528 Determination of tensile stress-strain properties of vulcanized rubber or thermoplastic rubber
Plastics -- Determination of density of non-foam plastics -- Part 1 . Dipping method, liquid pycnometer method and titration method
Plastics -- Determination of density of non-foam plastics -- Part 2. Density gradient column method
Plastics -- Determination of density of non-foam plastics -- Part 3 . Gas pycnometer method
GB/T 1034 Determination of water absorption of plastics
GB/T 1040.1 Determination of tensile properties of plastics - Part 1. General
Determination of tensile properties of plastics - Part 2. Test conditions for moulding and extruded plastics
Determination of tensile properties of plastics - Part 3. Test conditions for films and sheets
Determination of tensile properties of plastics - Part 4. Isotropic and orthotropic fiber reinforced composites
Test condition
GB/T 1041 Determination of compression properties of plastics
GB/T 1448 fiber reinforced plastics compression performance test method
GB/T 1632.1 Determination of viscosity and intrinsic viscosity of dilute solution of polymer
GB/T 1632.3 Plastics - Determination of viscosity of polymer dilute solutions - Part 3. Polyethylene and polypropylene
GB/T 1632.5 Determination of viscosity of polymer dilute solutions using capillary viscometer - Part 5. Thermoplastic homopolymerization and copolymerization
Polyester (TP)
GB/T 1634.1 Determination of deformation temperature of plastics - Part 1. General test methods
Plastics -- Determination of deformation temperature of plastics - Part 2. Plastics, hard rubber and long fibre reinforced composites
GB/T 2547 plastic sampling method
Test method for flexural properties of GB/T 3356 oriented fiber reinforced polymer matrix composites
GB/T 3358.1 Statistical vocabulary and symbols - Part 1. General statistical terms and terms for probabilities
GB/T 3358.2 Statistical vocabulary and symbols - Part 2. Application statistics
GB/T 3358.3 Statistical vocabulary and symbols - Part 3. Experimental design
GB/T 3682 Determination of melt flow rate and melt volume flow rate of thermoplastics
GB/T 6379.1 Accuracy of measurement methods and results (accuracy and precision) Part 1. General and definition
GB/T 6379.2 Accuracy of measurement methods and results (accuracy and precision) Part 2. Determination of standard method of measurement
Basic method of sex and reproducibility […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 528Rubber, vulcanized or thermoplastic -- Determination of tensile stress-strain properties
- GB/T 1034Plastics -- Determination of water absorption
- GB/T 1040.1Plastics - Determination of tensile properties - Part 1: General principles
- GB/T 1041Plastics -- Determination of compressive properties
- GB/T 1448Fiber-reinforced plastics composites-Determination of compressive properties
- GB/T 1632.1Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometers - Part 1:GEneral principles
Similar standards
Editions of YY/T 1616
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1616-2018 | Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds | current edition | Current |
| YY/T 0606.5-2007 | Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds | previous edition | Superseded |
This page sells the current edition, YY/T 1616-2018. Earlier editions are listed for reference only.
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Related Standards
GB/T 1034-2008 — Plastics -- Determination of water absorption
GB/T 1040.1-2025 — Plastics - Determination of tensile properties - Part 1: General principles
GB/T 1041-2008 — Plastics -- Determination of compressive properties
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