GB 12264-1990
Replaced
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
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
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
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced