GB 12264-1990
Replaced
GB/T 22750.2-2024
Active
National standards
GB/T 22750.2-2024 Implants for surgery—Ceramic materials—Part 2:Composite materials based on a high purity alumina matrix with zirconia reinforcement
GB/T 22750.2-2024 Implants for surgery—Ceramic materials—Part 2:Composite materials based on a high purity alumina matrix with zirconia reinforcement
Basic Information
Standard Code:
GB/T 22750.2-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2024-10-26
Implement Date:
2025-11-01
Pages:
20 pages
Scope
This document specifies the performance requirements for biostable ceramic bone replacement materials (zirconia-toughened high-purity alumina-based composites) for joint replacement, and describes the corresponding test methods.
This document applies to an alumina-based composite material, in which alumina accounts for more than 60% of the composite's mass fraction. It is similar to the material described in GB/T 22750.1, but with the addition of a certain amount of zirconia and other specified components.
Note: The performance requirements specified in this document differ from those in GB/T 22750.1 in terms of strength and fracture toughness, and additional special requirements are added for zirconia-containing materials (see YYT 1715).
The additives' components are listed in the chemical composition specified in this document. Typical additives for alumina or zirconia ceramics include Mg, Y, Ce, etc. These additives help improve the mechanical properties and chemical stability of alumina-zirconia composite materials.
This document does not include biocompatibility evaluation (see GB/T 16886.1). It is the manufacturer's responsibility to evaluate the biocompatibility of specific composite ceramic materials produced in accordance with the framework specified in this document.
Development Information
Same series standard
Referenced Standards
GB/T 6569-1986 Testing method for flexural strength of high performance ceramics
GB/T 6569-2006 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for flexural strength of monolithic ceramics at room temperature
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 21114-2007 Chemical analysis of refractory products by XRF—Fused cast bead method
GB/T 21114-2019 Refractories—Chemical analysis by X-ray fluorescence(XRF)—Fused cast-bead method
GB/T 23806-2009 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for fracture toughness of monolithic ceramics at room temperature by single edge precracked beam(SEPB)method
GB/T 25995-2010 Test methods for density and apparent porosity of fine ceramics
GB/T 40005-2021 Weibull statistics for strength data of fine ceramics
GB/T 42667-2023 Test method for equibiaxial flexural strength of fine ceramics at room temperature—Ring-on-ring method
GB/T 43296-2023 Test method for bending fatigue of fine ceramics at room temperature
YY/T 0651.1-2008 Implant for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
YY/T 0651.1-2016 Implants for surgery—Wear of total hip-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
YY/T 1426.1-2016 Implants for surgery—Wear of total knee-joint prostheses—Part 1:Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
YY/T 1427-2016 Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
YY/T 1715-2020 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP)
ISO 13383-1
ISO 17561
ISO 18756
ISO 23146
ASTM C1161
ASTM C1198
ASTM C1239
ASTM C1259
ASTM C1327
ASTM C1331
ASTM C1421
CEN/TS 14425-5
EN 623-2
EN 623-3
EN 843-1
EN 843-2
EN 843-4
EN 843-5
GB/T 23806-2025 Test method for fracture toughness of fine ceramics at room temperature—Single edge precracked beam(SEPB) method
Adopt standards
ISO 6474-2:2019
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