GB 12264-1990
Replaced
YY/T 0964-2014
Active
Industry standards-Medicine
YY/T 0964-2014 Implants for surgery—Bioglass and glass ceramic biomaterials
YY/T 0964-2014 Implants for surgery—Bioglass and glass ceramic biomaterials
Basic Information
Standard Code:
YY/T 0964-2014
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2014-06-17
Implement Date:
2015-07-01
Pages:
12 pages
Scope
This standard specifies the material requirements and testing techniques for bioglass and glass ceramics used in surgical implants. The materials described in this standard can be used in porous and powdered surgical implants, as well as coatings for surgical instruments, but do not include drug delivery systems. The biological response of bioglass and glass ceramics to bone and soft tissues has been verified in clinical applications and laboratory studies.
This standard does not include synthetic hydroxyapatite, hydroxyapatite-coated alumina ceramics, α-tricalcium phosphate, and β-tricalcium phosphate, as well as white phosphate calcium.
Development Information
Referenced Standards
中华人民共和国药典 (二部)
JC/T 678
ASTM C 633
GB/T 1347-1988 Chemical analysis of soda-lime-silica glass
GB/T 1347-2008 Methods for chemical analysis of soda-lime-silica glass
GB/T 5432-1985 The density of daily use glass—Test method
GB/T 5432-2008 Test method for density of glass by buoyancy
GB/T 6040-2002 General rules for infrared analysis
GB/T 6040-2019 General rules for infrared analysis
GB/T 6524-2003 Metallic powders-Determination of particle size distribution by gravitational sedimentation in a liquid and attenuation measurement
GB/T 6609.35-2009 Chemical analysis methods and determination of physical performance of alumina—Part 35:Determination of specific surface area by nitrogen adsorption
GB/T 6609.35-2023 Chemical analysis methods and determination of physical performance of alumina—Part 35:Determination of specific surface area—Nitrogen adsorption method
GB/T 14901-1994 Test method for density of glass—Method of the sink-float comparison
GB/T 14901-2008 Test method for density of glass—Method of the sink-float comparison
GB/T 16534-1996 Test method for Vickers hardness of high performance ceramics
GB/T 16534-2009 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for hardness of monolithic ceramics at room temperature
GB/T 16535-1996 Test method for linear thermal expansion of high performance ceramics
GB/T 16535-2008 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for linear thermal expansion of monolithic ceramics by push-rod technique
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 19077.1-2003 Particle size analysis—Laser diffraction method
GB/T 19077.1-2008 Particle size analysis—Laser diffraction methods—Part 1:General principles
GB/T 23101.4-2008 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength
GB/T 23101.4-2023 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength
JC/T 676-1997 Test method for flexure of glass material
JY/T 009-1996 General rules for X-ray polycrystalline diffractometry
QB/T 3572-1999 The chemical analysis method for borosilicate glass
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