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YY/T 1616-2018 English PDF

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YY/T 1616-2018: Tissue engineering medical device products. Standard guide for characterization and testing of biomaterial scaffolds
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YY/T 1616-2018English379 Add to Cart 3 days [Need to translate] Tissue engineering medical device products. Standard guide for characterization and testing of biomaterial scaffolds Valid YY/T 1616-2018

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Standard similar to YY/T 1616-2018

YY/T 1680   YY/T 1561   YY/T 1571   YY/T 1925   YY/T 1620   

Basic data

Standard ID YY/T 1616-2018 (YY/T1616-2018)
Description (Translated English) Tissue engineering medical device products. Standard guide for characterization and testing of biomaterial scaffolds
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 19,150
Date of Issue 2018-11-07
Date of Implementation 2019-11-01
Older Standard (superseded by this standard) YY/T 0606.5-2007
Quoted Standard GB/T 528; GB/T 1033.1; GB/T 1033.2; GB/T 1033.3; GB/T 1034; GB/T 1040.1; GB/T 1040.2; GB/T 1040.3; GB/T 1040.4; GB/T 1041; GB/T 1448; GB/T 1632.1; GB/T 1632.3; GB/T 1632.5; GB/T 1634.1; GB/T 1634.2; GB/T 2547; GB/T 3356; GB/T 3358.1; GB/T 3358.2; GB/T 335
Regulation (derived from) Announcement No. 87 of 2018 by the State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the chemical properties and test methods, physical properties and test methods, mechanical properties and test methods, biological tests and evaluations, degradation properties and tests, sterilization, quality assurance, etc. of biomaterial scaffolds. This standard applies to the performance evaluation of biomaterial scaffolds for the preparation of tissue engineering medical device products.

YY/T 1616-2018: Tissue engineering medical device products. Standard guide for characterization and testing of biomaterial scaffolds


---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 characterization and testing of biomaterial scaffolds ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0606.5-2007 Tissue engineering medical device products Biomaterial support performance and test guide Published on.2018-11-07 2019-11-01 implementation State Drug Administration issued

Content

Foreword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 3 4 stent chemistry and test methods 4 5 stent physical properties and test methods 5 6 Bracket mechanical properties and test methods 7 7 Biological tests and evaluations 8 8 stent degradation performance and test 9 9 Sterilization 9 10 Quality Assurance 9 Appendix A (informative) Characterization of scaffold porosity 11 Appendix B (informative) Supplemental scaffold material properties and testing 12 Reference 14

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0606.5-2007 "Organic Engineering Medical Products Part 5. Performance and Testing of Substrates and Stents", and Compared with YY/T 0606.5-2007, the main technical changes except editorial changes are as follows. --- The standard name was changed to "Guidelines for Performance and Testing of Biomaterial Stents for Tissue Engineering Medical Device Products"; --- The scope was modified to "given the performance and test guidelines for biomaterial scaffolds"; --- The version number is removed from the normative reference file; --- The term "natural materials" and "matrix" are removed from the terms and definitions; --- Removed the "Material Performance and Testing" section; --- Added "5.2 Image Analysis" terms; --- Added four items including n), o), p), q) under the "7.2 Biological Test and Evaluation" clause; --- Added 8.6 clauses in the chapter "8 Scaffold Degradation Performance and Testing"; --- Modified Appendix B. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices. (SCA/TC110/SC3) is under the jurisdiction. This standard was drafted. China Food and Drug Control Research Institute. The main drafters of this standard. Chen Liang, Yan Tingfei, Wang Chunren, Fan Chengxiang. The previous versions of the standards replaced by this standard are. ---YY/T 0606.5-2007.

Introduction

This standard is dedicated to providing techniques and test methods for the characterization of materials related to stent performance, covering the physical and chemical aspects of the stent body. Learning, mechanics and surface properties. These characteristics may affect the retention of cells on the scaffold, cell activity and tissue formation, biological activity The transport of factors, biocompatibility of the final product, and biological activity are important for the effectiveness of tissue engineering medical device products. The stent may be constructed of metal, ceramic, polymer, natural or composite material, and may be solid or porous, rigid or gel-like, The rack may be degradable or not absorbed, and the scaffold may be surface treated. This shows that the type and performance of the bracket is very extensive, and each The stents for tissue engineering medical device products are unique, and this standard lists test methods that may be applicable, but is not limited to these. Recommended Standard users view the references listed here, as well as relevant technical guidance from national drug regulatory authorities and other regulatory agencies. Principles or specifications, and literature queries to identify other techniques and test methods associated with evaluating specific scaffold materials. Finalized Suitable test methods may not be limited to the methods described in this standard. This standard is written with reference to the ASTMF2150-2013 standard "StandardGuideforCharacterization and Testing" "ofBiomaterialScaffoldsUsedinTissue-EngineeredMedicalProducts", will give a framework to evaluate possible Materials used as stents, including metals, ceramics, polymers, and composites, including absorbable and non-absorbable materials. About these biomedicines GB, ISO , and ASTM have published many test methods for the evaluation of material body and surface properties, so this standard is dedicated to including this. Some methods. This standard provides relevant standards and test methods for the performance and testing of stents in tissue engineering medical device products. But group The number of materials that can be applied to woven engineering medical products is so large that there is no general guideline for selecting the material tests that should be performed. this The standard does not list all relevant bracket safety requirements and therefore the safety requirements for specific purpose brackets need to be established. Tissue engineering medical device products Biomaterial support performance and test guide

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

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