GB 12264-1990
Replaced
YY/T 1616-2018
Active
Industry standards-Medicine
YY/T 1616-2018 Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds
YY/T 1616-2018 Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds
Basic Information
Standard Code:
YY/T 1616-2018
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:
2018-11-07
Implement Date:
2019-11-01
Pages:
19 pages
Scope
This standard specifies the chemical properties and testing methods, physical properties and testing methods, mechanical properties and testing methods, biological tests and evaluations, degradation performance and tests, sterilization, quality assurance, and other aspects of biomaterial scaffolds for tissue engineering medical device products.
This standard is applicable to the performance evaluation of biomaterial scaffolds used in the preparation of tissue engineering medical device products.
Development Information
Replace the following standards
Referenced Standards
GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB/T 528-2009 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties
GB/T 1033.1-2008 Plastics—Methods for determining the density of non-cellular plastics—Part 1:Immersion method,liquid pyknometer method and titration method
GB/T 1033.2-2010 Plastics—Methods for determining the density of non-cellular plastics—Part 2:Density gradient column method
GB/T 1033.3-2010 Plastics—Methods for determining the density of non-cellular plastics—Part 3:Gas pyknometer method
GB/T 1034-1998 Plastics—Determination of water absorption
GB/T 1034-2008 Plastics—Determination of water absorption
GB/T 1040.1-2006 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.1-2018 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.1-2025 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.2-2022 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
GB/T 1040.4-2006 Plastics—Determination of tensile properties—Part 4:Test conditions for isotropic and orthotropic fibre-reinforced plastic composites
GB/T 1041-2008 Plastics—Detemination of compressive properties
GB/T 1448-2005 Fiber-reinforced plastics composites—Determination of compressive properties
GB/T 1632.1-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles
GB/T 1632.1-2024 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles
GB/T 1632.3-2010 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometer—Part 3:Polyethylenes and polypropylenes
GB/T 1632.5-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 5:Thermoplastic polyester(TP) homopolymers and copolymers
GB/T 1634.1-2004 Plastics—Determination of temperature of deflection under load—Part 1:General test method
GB/T 1634.1-2019 Plastics—Determination of temperature of deflection under load—Part 1:General test method
GB/T 1634.1-2025 Plastics—Determination of temperature of deflection under load—Part 1:General test method
GB/T 1634.2-2004 Plastics—Determination of temperature of deflection under load—Part 2:Plastics,ebonite and long-fibre-reinforced composites
GB/T 1634.2-2019 Plastics—Determination of temperature of deflection under load—Part 2:Plastics and ebonite
GB/T 2547-1981 Plastic resins—Sampling
GB/T 2547-2008 Plastic resins—Sampling
GB/T 3356-1999 Test method for flexural properties of unidirectional fiber reinforced plastics
GB/T 3356-2014 Test method for flexural properties of orientational fiber reinforced polymer metrix composite materials
GB/T 3358.1-1993 Terms for statistics—Part 1:Terms for general statistics
GB/T 3358.1-2009 Statistics—Vocabulary and symbols—Part 1:General statistical terms and terms used in probability
GB/T 3358.2-1993 Terms for statistics—Part 2:Terms for statistical quality control
GB/T 3358.2-2009 Statistics—Vocabulary and symbols—Part 2:Applied statistics
GB/T 3358.3-1993 Terms for statistics—Part 3:Terms for experimental design
GB/T 3358.3-2009 Statistics—Vocabulary and symbols—Part 3:Design of experiments
GB/T 3682-2000 Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics
GB/T 3682.1-2018 Plastics—Determination of the melt mass-flow rate(MFR)and melt volume-flow rate(MVR)of thermoplastics—Part 1:Standard method
GB/T 3682.2-2018 Plastics—Determination of the melt mass-flow rate(MFR)and melt volume-flow rate(MVR)of thermoplastics—Part 2:Method for materials sensitive to time-temperature history and/or moisture
GB/T 6379.1-2004 Accuracy(trueness and precision)of measurement methods and results—Part 1:General principles and definitions
GB/T 6379.2-2004 Accuracy(trueness and precision)of measurement methods and results—Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method
GB/T 6425-1986 Nomenclature for thermal analysis
GB/T 6425-2008 Nomenclature for thermal analysis
GB/T 8813-2008 Rigid cellular plastics—Determination of compression properties
GB/T 8813-2020 Rigid cellular plastics—Determination of compression properties
GB/T 9341-2000 Plastics—Determination of flexural properties
GB/T 9341-2008 Plastics—Determination of flexural properties
GB/T 11415-1989 Laboratory sintered (fritted) filters—Porosity grading, classification and designation
GB/T 11546.1-2008 Plastic—Determination of creep behaviour—Part 1:Tensile creep
GB 16352-1996 Standards for γ-rays radiation sterilization of disposable medical appliances
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
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