GOST R ISO 6474-1-2014 Implants for surgery Ceramic materials Part 1 Ceramic materials based on high purity alumina《外科植入物 陶瓷材料 第1部分 基于高纯氧化铝的陶瓷材料》.pdf

1、 6474-12014 1 ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina (IDT) 6474-12014 II 1 ( ) , 4 2 453 3 12 2014 . 2071- 4 6474-1:2010 . . 1. (ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purit

2、y alumina) , A 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 , 6474-12014 III , , . , , 6474, , . 6474-12014 1 1 Implants for surgery. Ceramic materials. Part 1. Ceramic materials based on high purity alumina 20160101 1 6474 , , . 2 : 31 ( ) (ISO 31 (all parts), Quantities and units) 12677 (XRF)

3、. (ISO 12677, Chemical analysis of refractory products by X-ray fluorescence (XRF) Fused cast-bead method) 13356 . , (Y-TZP) (ISO 13356, Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) 14704 ( , ). (ISO 14704, Fine ceramics (advanced ceramics, advanced t

4、echnical ceramics) Test method for flexural strength of monolithic ceramics at room temperature) 14705 ( , ). (ISO 14705, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for hardness of monolithic ceramics at room temperature) 15732 ( , ). (SEPB) (ISO 15732, Fine ceramics

5、(advanced ceramics, advanced technical ceramics) Test method for fracture toughness of monolithic ceramics at room temperature by single edge precracked beam (SEPB) method) 17561 ( , ). (ISO 17561, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for elastic moduli of monol

6、ithic ceramics at room temperature by sonic resonance) 18754 ( , ). (ISO 18754, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity) 18756 ( , ). (SCF) (ISO 18756, Fine ceramics (advanced ceramics, advanced technical ceramics) Determination o

7、f fracture toughness of monolithic ceramics at room temperature by the surface crack in flexure (SCF) method) 6474-12014 2 20501 ( , ). (ISO 20501, Fine ceramics (advanced ceramics, advanced technical ceramics) Weibull statistics for strength data) 22214 ( , ). (ISO 22214, Fine ceramics (advanced ce

8、ramics, advanced technical ceramics) Test method for cyclic bending fatigue of monolithic ceramics at room temperature) 23146 ( , ). . V- (SEVNB) (ISO 23146, Fine ceramics (advanced ceramics, advanced technical ceramics) Test methods for fracture toughness of monolithic ceramics Single-edge V-notch

9、beam (SEVNB) method) EN 623-2 . . . 2: (EN 623-2, Advanced technical ceramics Monolithic ceramics General and textural properties Part 2: Determination of density and porosity) EN 623-3 . . . 3: ( ) (EN 623-3, Advanced technical ceramics Monolithic ceramics General and textural properties Part 3: De

10、termination of grain size and size distribution (characterized by the Linear Intercept Method) EN 843-1 . . 1. (EN 843-1, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 1: Determination of flexural strength) EN 843-2 . . 2. , (EN 843-2, Advanced tec

11、hnical ceramics Mechanical properties of monolithic ceramics at room temperature Part 2: Determination of Youngs modulus, shear modulus and Poissons ratio) EN 843-4 . . 4. , (EN 843-4, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 4: Vickers, Knoop

12、 and Rockwell superficial hardness) EN 843-5 . . 5. (EN 843-5, Advanced technical ceramics Mechanical properties of monolithic ceramics at room temperature Part 5: Statistical analysis) CEN/TS 14425-5 . . 5. V- (SEVNB) (CEN/TS 14425-5, Advanced technical ceramics Test methods for determination of fr

13、acture toughness of monolithic ceramics Part 5: Single-edge vee-notch beam (SEVNB) method) ASTM C1161 (ASTM C1161, Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature) ASTM C1198 , (ASTM C1198, Standard Test Method for Dynamic Youngs Modulus, Shear Modulus, and Poi

14、ssons Ratio forAdvanced Ceramics by Sonic Resonance) ASTM C1239 (ASTM C1239, Standard Practice for Reporting Uniaxial Strength Data and Estimating Weibull Distribution Parameters for Advanced Ceramics) ASTM C1259 , (ASTM C1259, Standard Test Method for Dynamic Youngs Modulus, Shear Modulus, and Pois

15、sons Ratio for Advanced Ceramics by Impulse Excitation of Vibration) ASTM C1327 (ASTM C1327, Standard Test Method for Vickers Indentation Hardness of 6474-12014 3Advanced Ceramics ASTM C1331 (ASTM C1331, Standard Test Method for Measuring Ultrasonic Velocity in Advanced Ceramics with Broadband Pulse

16、-Echo Cross-Correlation Method) ASTM C1421 (ASTM C1421, Standard Test Methods for Determination of Fracture Toughness of Advanced Ceramics at Ambient Temperature) ASTM C1499 (ASTM C1499, Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature) AST

17、M E112 (ASTM E112, Standard Test Methods for Determining Average Grain Size) 3 3.1 . , (, ). , (, , ). 3.2 3.2.1 1 2. , 5.6, 5.8 5.9, . 3.2.2 1: , : ) ; b) ;c) ;d) .3.2.3 2: . , 3.2.2, : ) ; b) ;c) ;d) ;) . 3.3 6474, , 1. (), 31. 6474-12014 4 1 /3 1031 3,94 3,90 5.1 18754 EN 623-2 - Al2O3% 1 99,7 99

18、,5 MgO % 1 0,2 0,2 5.2 12677 , SiO2+ CaO + Na2O % 1 0,1 0,3 EN 623-3 1 2,5 3,5 5.3 ASTM E112 % 1 25 25 13356 , 1) 2)5.4 1) 1 300 150 5.4.2 ASTM C1499 1b) - 1 8 8 5.4.4 20501 EN 843-5 ASTM C1239 2) 4 1 500 250 5.4.3 14704 EN 843-1 ASTM C1161 2b) - 1 8 8 5.4.4 20501 EN 843-5 ASTM C1239 2 380 370 5.5 17561 EN 843-2 ASTM C1331 ASTM C1198 ASTM C1259 , 1) 3) 5.6 1) SEVNB 2 2,5 5.6.2 23146 CEN/TS 14425-52)