YY/T 1716-2020 Active Industry standards-Medicine

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

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

Publish Date: 2020-06-30 Implement Date: 2021-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1716-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2020-06-30
Implement Date: 2021-06-01
Pages: 12 pages

Scope

This standard provides methods for characterizing the chemical, physical, biological, and mechanical properties of biocompatible ceramic and mineral-based scaffolds in tissue engineering medical device products. This standard is applicable to the performance analysis of final products containing ceramic and mineral scaffold structures, as well as the comprehensive evaluation of raw materials, particles, and preformed blocks involved in the scaffold production process. Note: The release performance of biomolecules, cells, drugs, or biologically active components is not covered by this standard.

Development Information

Word Count: 16 Thousand words Pages: 12 pages

Referenced Standards

YY/T 1445-2016 Tissue engineering medical device products—Terminology 《中华人民共和国药典》(2015年版)四部 GB/T 1964-1996 Test method for crushing strength of porous ceramic GB/T 1964-2023 Porous ceramics—Test method for compressive strength at room temperature GB/T 1966-1996 Test method for apparent porosity and bulk density of porous ceramic GB/T 1966-2024 Porous ceramics—Determination of apparent porosity and bulk density GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics GB/T 19466.1-2004 Plastics—Differential scanning calorimetry(DSC)—Part 1:General principles GB/T 19466.2-2004 Plastics—Differential scanning calorimetry(DSC)—Part 2:Determination of glass transition temperature GB/T 19466.3-2004 Plastics—Differential scanning calorimetry(DSC)—Part 3:Determination of temperature and enthalpy of melting and crystallization GB/T 19587-2004 Determination of the specific surface area of solids by gas adsorption using the BET method GB/T 19587-2017 Determination of the specific surface area of solids by gas adsorption using the BET method GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 21650.1-2008 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 1:Mercury porosimetry GB/T 21650.2-2008 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 2:Analysis of mesopores and macropores by gas adsorption GB/T 21650.3-2011 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 3:Analysis of micropores by gas adsorption GB 23101.1-2008 Implants for surgery—Hydroxyapatite—Part 1:Ceramic hydroxyapatite GB/T 27761-2011 Standard test method of mass loss and residue measurement validation of thermogravimetric analyzers GB/T 27762-2011 Standard test method for mass scale calibration of thermogravimetric analyzers GB/T 30758-2014 Refractory products—Determination of dynamic Young's modulus(MOE) by impulse excitation of vibration YY/T 0683-2008 Standard specification for beta-tricalcium phosphate for surgical implantation GB/T 19466.1-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 1:General principles GB/T 19466.2-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 2:Determination of glass transition temperature and step height GB/T 19466.3-2025 Plastics—Differential scanning calorimetry(DSC) method—Part 3:Determination of temperature and enthalpy of melting and crystallization GB/T 21650.1-2026 Evaluation of pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 1:Mercury porosimetry

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