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YY/T 1294.2-2015: Implants for Surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcemen
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Implants for Surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcemen
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YY/T 1294.2-2015
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Basic data | Standard ID | YY/T 1294.2-2015 (YY/T1294.2-2015) | | Description (Translated English) | Implants for Surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcemen | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,170 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | ISO 6474-1; ISO 12677; ISO 13356; ISO 14242-1; ISO 14243-1; ISO 14704; ISO 14705; ISO 15732; ISO 16428; ISO 17561; ISO 18754; ISO 18756; ISO 20501; ISO 22214; ISO 23146; CEN/TS 14425-5; EN 623-2; EN 623-3-1993; EN 843-1; EN 843-2; EN 843-4; EN 843-5; ASTM C1161; ASTM C1198; ASTM C1239; ASTM C1259; ASTM C1327; ASTM C1331; ASTM C1421; ASTM C1499 | | Adopted Standard | ISO 6474-2-2012, IDT | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the performance and the corresponding test methods biocompatible and bio-stable ceramic bone substitute material (zirconia toughened high purity alumina matrix composites) joint replacement. The purpose of this section is to provide for a alumina matrix composite, that the proportion of alumina composite mass fraction of more than 60%, similar to the material described in ISO 6474-1, but adding a certain amount of zirconia and other clear The composite component. | YY/T 1294.2-2015: Implants for Surgery - Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcemen
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for Surgery.Ceramic materials.Part 2. Composite materials based on a high purity alumina matrix with zirconia reinforcemen
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Surgical implants of ceramic materials - Part 2. zirconia
Toughening high purity alumina matrix composites
ImplantsforSurgery-Ceramicmaterials-Part 2. Compositematerials
(ISO 6474-2.2012, IDT)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
YY/T 1294 "surgical implants ceramic material" or has plans to release the following sections.
--- Part 1. High-purity alumina-based ceramic material;
--- Part 2. zirconia toughened high purity alumina matrix composites.
This section YY/T 1294 Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 6474-2.2012 "surgical implants of ceramic materials - Part 2. zirconia toughened high
Pure alumina matrix composites "(in English).
The standard international documents and normative references corresponding to the consistency of the following documents.
--- GB/T 21114-2007 Refractories X-ray fluorescence spectroscopy for chemical analysis of cast glass method (ISO 12677.
2003, MOD);
Part 1 wear --- YY/T 0651.1-2008 surgical implant total hip prosthesis. hip wear tester negative
Load and displacement parameters and related environmental test conditions (ISO 14242-1.2002, MOD);
--- GB/T 6569-2006 fine ceramic bending strength test method (ISO 14704.2000, MOD);
--- GB/T 16534-2009 fine ceramics at room temperature hardness test methods (ISO 14705.2008, MOD);
--- GB/T 23806-2009 Test method for fracture toughness of fine ceramics unilateral pre-cracked beam (SEPB) method (ISO 15732.
2003, MOD);
--- GB/T 25995-2010 fine ceramics density and porosity test methods (ISO 18754.2003, MOD).
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized.
This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, the State Food and Drug Pipe
Li Administration Medical Device Evaluation Center.
The main drafters of this section. Ma Chun Bao, ZHANG Wen-hui, Liu Bin, Dong Wenxing.
Surgical implants of ceramic materials - Part 2. zirconia
Toughening high purity alumina matrix composites
1 Scope
YY/T 1294 provisions of this part of the joint replacement with biocompatible and biostable ceramic bone substitute material (high purity zirconia toughened
Performance test methods and corresponding alumina matrix composite material).
The purpose of this section is to provide for a alumina matrix composite, that the proportion of alumina composites with mass fraction of more than 60%
On similar materials as described in ISO 6474-1, but adding a certain amount of composite oxide of zirconium and other specific ingredients.
Note. The performance requirements specified in this section is different from ISO 6474-1 in strength and fracture toughness, and increased the number for zirconia-containing material
Particular requirements (see ISO 13356).
It lists the additive ingredients in the chemical composition of the provisions of this Part. For alumina or zirconia ceramics typical additives
Mg, Y, Ce and the like. These additives help to improve alumina - zirconia composite mechanical properties and chemical stability. This section does not include
Include inorganic additive in humans biocompatibility evaluation (see ISO 10993-1). In accordance with a specific evaluation framework in this section to production
Biocompatible composite ceramic material is the manufacturer's responsibility.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 6474-1 Implants for surgery - Ceramic materials - Part 1. High-purity alumina-based ceramic material (Implantsforsurgery-
Ceramicmaterials-Part 1. Ceramicmaterialsbasedonhighpurityalumina)
ISO 12677 refractories X-ray fluorescence spectrometry (XRF) method for chemical analysis of cast glass (Chemicalanalysisof
refractoryproductsbyX-rayfluorescence (XRF) -Fusedcastbeadmethod)
ISO 13356 Implants for surgery yttria-stabilized tetragonal zirconia (Y-TZP) ceramic materials (Implantsfor
surgery-Ceramicmaterialsbasedonyttria-stabilizedtetragonalzirconia (Y-TZP))
ISO 14242-1 Implants for surgery - Wear of total hip joint prostheses - Part 1. Load and displacement parameters for wear testing machines and corresponding
The test environment condition (Implantsforsurgery-Wearoftotalhip-jointprostheses-Part 1. Loadinganddis-
placementparametersforwear-testingmachinescorrespondingenvironmentalconditionsfortest)
ISO 14243-1 Implants for surgery - Wear of total knee prostheses - Part 1. load control and load displacement Wear Testing Machine
Test parameters and corresponding environmental conditions (Implantsforsurgery-Wearoftotalknee-jointprostheses-Part 1.
Loadinganddisplacementparametersforwear-testingmachineswithloadcontrolandcorresponding
enviormentalconditionsfortest)
Test methods ISO 14704 Fine ceramics (advanced ceramics, advanced technical ceramics) at room temperature flexural strength of monolithic ceramics (Fine
ceramics (advancedceramics, advancedtechnicalceramics) -Testmethodforflexuralstrengthof
monolithicceramicsatroomtemperature.)
ISO 14705 Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for monolithic ceramics at room temperature hardness [Fineceramics
(Advancedceramics, advancedtechnicalceramics) -Testmethodforhardnessofmonolithicceramics
atroomtemperature]
ISO 15732 Fine ceramics (advanced ceramics, advanced technical ceramics) measured at room temperature bulk Tao unilateral pre-existing cracks beam method (SEPB)
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