YY/T 1716-2020Tissue engineering medical device products - Characterization of ceramic and mineral based scaffolds (English PDF)

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 beta-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.