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YY/T 1716-2020 English PDF

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YY/T 1716-2020: Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1716-2020	English	189	Add to Cart	3 days [Need to translate]	Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds	Valid	YY/T 1716-2020

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Basic data

Standard ID	YY/T 1716-2020 (YY/T1716-2020)
Description (Translated English)	Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	10,179
Date of Issue	2020-06-30
Date of Implementation	2021-06-01
Issuing agency(ies)	State Drug Administration

YY/T 1716-2020: Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds

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Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Characterization of ceramic and mineral scaffolds for tissue engineering medical device products 2020-06-30 released 2021-06-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. Publication of this document The agency 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, and the Sub-Technical Committee (SAC/TC110/SC3) Centralized. Drafting organization of this standard. China Institute for Food and Drug Control. The main drafters of this standard. Wang Anqi, Feng Xiaoming, Ke Linnan, Wang Chunren, Huang Yuanli. Characterization of ceramic and mineral scaffolds for tissue engineering medical device products

1 Scope

This standard specifies the chemical, physical and biological properties of biocompatible ceramic and mineral-based scaffolds in tissue engineering medical device products. Characterization methods of performance and mechanical properties. This standard applies to the performance analysis of final products containing ceramic and mineral stent structures, as well as the raw materials and materials involved in the stent production process. Comprehensive evaluation of pellets and preformed blocks. Note. The release properties of biomolecules, cells, drugs or biologically active components are not covered by this standard.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T 1964 Compressive strength test method of porous ceramics GB/T 1966 Test method for apparent porosity and bulk density of porous ceramics GB/T 16886.14 Biological Evaluation of Medical Devices Part 14.Qualitative and Quantitative Ceramic Degradation Products GB/T 19466.1 Plastic Differential Scanning Calorimetry (DSC) Part 1.General GB/T 19466.2 Plastic Differential Scanning Calorimetry (DSC) Part 2.Determination of Glass Transition Temperature GB/T 19466.3 Differential Scanning Calorimetry (DSC) for Plastics Part 3.Determination of Melting and Crystallization Temperature and Enthalpy GB/T 19587 Gas adsorption BET method for determination of specific surface area of solid matter GB/T.19973.1 Sterilization Microbiological Methods of Medical Devices Part 1.Determination of the total number of microorganisms on the product GB/T 21650.1 Determination of pore size distribution and porosity of solid materials by mercury intrusion method and gas adsorption method Part 1.Mercury intrusion method GB/T 21650.2 Determination of pore size distribution and porosity of solid materials by mercury intrusion method and gas adsorption method Part 2.Analysis of mesopores and macropores by gas adsorption method GB/T 21650.3 Determination of pore size distribution and porosity of solid materials by mercury intrusion method and gas adsorption method Part 3.Analysis of micropores by gas adsorption method GB 23101.1 Surgical implants Hydroxyapatite Part 1.Hydroxyapatite ceramics GB/T 27761 Test method for weight loss and remaining amount of thermogravimetric analyzer GB/T 27762 Test method for calibrating the quality indication of thermogravimetric analyzer GB/T 30758 Test method for dynamic Young's modulus of refractory materials (pulse excitation method) YY/T 0683 β-Tricalcium phosphate for surgical implants YY/T 1445-2016 Tissue Engineering Medical Device Product Terminology "The Pharmacopoeia of the People's Republic of China" (2015 edition) four volumes

3 Terms and definitions

The following terms and definitions defined in YY/T 1445-2016 apply to this document. For ease of use, the following is repeated Certain terms and definitions in YY/T 1445.

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