KS P ISO 13356-2009 Implants for surgery－Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP)《外科植入物 含有稳定氧化钇的四方氧化锆陶瓷材料(Y-TZP)》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 13356 (Y-TZP) KS P ISO 13356:2009 2009 12 21 http:/www.kats.go.krKS P ISO 13356:2009 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2004 11 22 ：2009 12 21 2009-0834 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO 13356:2009 i . ii

2、1 1 2 1 3 , (physical and chemical properties) 1 4 (test methods) .2 4.1 (bulk density)2 4.2 (chemical composition) 2 4.3 (microstructure) 2 4.4 (biaxial flexural strength) .6 4.5 4 (4-point bending strength) 9 4.6 (cyclic fatigue).9 4.7 (radioactivity) .10 4.8 (accelerated aging test).12 14 KS P IS

3、O 13356:2009 ii 2008 2 ISO 13356, Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP) , . . . KS P ISO 13356:2009 (Y-TZP) Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP) 1 Y-TZP . 2 . . ( ) . KS B ISO 3611, KS B IS

4、O 7500 1, 1： / KS L ISO 18754, ISO 14704： 2008, Fine ceramics (advanced ceramics, advanced technical ceramics) Test method for flexural strength of monolithic ceramics at room temperature EN 623 2： 1993, Advanced technical ceramics Monolithic ceramics General and textural properties Part 2： Determin

5、ation of density and porosity EN 623 3： 1993, Advanced technical ceramics Monolithic ceramics General and textural properties Part 3： Determination of grain size and size distribution(characterized by the Linear Intercept Method) ASTM C 1499： 2008, Standard Test Method for Monotonic Equibiaxial Flex

6、ural Strength of Advanced Ceramics at Ambient Temperature ASTM E112 96(2004)e2, Standard Test Methods for Determining Average Grain Size ASTM G136 03, Standard Practice for Determination of Soluble Residual Contaminants in Materials by Ultrasonic Extraction ASTM . 3 , (physical and chemical properti

7、es) 4. , 1 . KS P ISO 13356:2009 2 1 g/cm3 6.00 4.1 ZrO2 HfO2 Y2O3 Y2O3 Hf2O3 Al2O3 99.0 4.5 6.0 5 0.5 0.5 4.2 m 0.4 4.3 0,18 20 % 4.3.7 a 4 MPa 500 800 4.4 4.5 106 MPa 320 4.6 bBq/kg 200 4.7 ： 4 25 % 500 MPa, 20 % 800 MPa, 20 % 4.8 a 10 b (238U), (226Ra), (232Th) , 200 Bq/kg . , . 4 (test methods)

8、4.1 (bulk density) KS L ISO 18754 EN 623 2 . 4.2 (chemical composition) - (ICP-OES), (fluorescent X-ray) . 4.3 (microstructure) 4.3.1 (principle) KS P ISO 13356:2009 3 EN 623 3 ASTM E112 . 4.3.2 (apparatus) . 4.3.2.1 (grinding and polishing devices) . 4.3.2.2 (furnace) 1 400 . 4.3.2.3 (scanning elec

9、tron microscope) 4.3.3 (preparation of test piece) EN 623 3 . a) , , . b) , 90 % . 200 . . c) . - . - . d) 5 . 4.4.3 4 4.4.5 . . e) . 1 . f) 1 300 1 400 30 60 . g) (Use) , , . 4.3.4 (procedure) EN 623 3 ASTM E 112 . a) . . EN 623 3 ASTM E 112 20 , 250 . . 10 000 . KS P ISO 13356:2009 4 . b) . c) 5 .

10、 10 000 . d) 1 (X-Y - ) 2( 0.05 mm) . 2 1 2 3 4 5 x 6 12 18 24 30 y 0.33 0.66 1.00 1.33 1.66 4 1 (X-Y - ) 3( 0.05 mm) . 3 4 1 2 3 4 5 x 7.5 15 22.5 30 37.5 y 0.5 1.0 1.5 2.0 2.5 e) 12 , 4 ( ), 4 (605) 4 (605) ( 1 ) . . f) ASTM E 112 . KS P ISO 13356:2009 5 a) b) 454 mm 1 2 ( ) 4 ( ) ： 4.3.5 (calcula

11、tion of results) . EN 623 3 ASTM E 112 . . 5 . . 4.3.6 (test report) KS P ISO 13356:2009 6 EN 623 3 . . a) , b) c) 5 d) ; . e) (： KS P ISO 13356) 4.3.7 (amount of monoclinic phase) ASTM F1873 98 4.4 X- . X- 4.3.3. “b)： ” . Garvie and Nicholson3 . 4.4 (biaxial flexural strength) 4.4.1 (principle) 2 .

12、 . ASTM C 1499 . 4.4.2 (apparatus) 4.4.2.1 (mechanical testing machine) (500100) N/s , 5 kN 1 % . 4.4.2.2 (test jig) 1 . (300.1) mm , (120.1) mm . (2.00.2) mm . , 0.2 mm . ( HV 500 HRC 40) . (0.60.1) mm 605 (Shore hardness) . . KS P ISO 13356:2009 7 4.4.2.3 (micrometer) KS B ISO 3611 0.01 mm . 4.4.3

13、 (preparation of test piece) , , . 2 (36.01.0) mm, (2.00.1) mm 0.3 mm . . 10 , Weibull 30 . 4.4.4 (procedure) 3 0.1 mm 0.01 mm . . . . , . (500100) N/s . . . 0.5 mm . . . . KS P ISO 13356:2009 8 2 4.4.5 (calculation of results) (MPa) . 2l2sls22)1(ln)1(23dddvddvtF2 F ： (N) t ： (mm) ds ： (mm) dl ： (mm

14、) d ： (mm) v ： (0.3 ) . 4.4.6 (test report) . a) , KS P ISO 13356:2009 9 b) c) , Weibull . (4.4.4 ) d) (： KS P ISO 13356) 4.5 4 (4-point bending strength) 4 ISO 14704 4 20 mm40 mm . , . 45 mm , (4.00.2) mm, (3.00.2) mm . (5.00.2) mm . (400.5) mm . (200.2) mm . . 4.6 (cyclic fatigue) 4.6.1 (principle

15、) 4 . 4.6.2 (apparatus) 4.6.2.1 (mechanical testing machine) . KS B ISO 7500 1 1 % 1 . . 4.6.2.2 (testing jig) ISO 14704 . . (40.00.1) mm . (20.00.05) mm . 4.6.3 (preparation of test piece) ISO 14704 . 5 . 4.6.4 (procedure) 5 Hz 20 Hz . 18 40 . 100 . max 320 MPa . KS P ISO 13356:2009 10 )(3221max2ma

16、xSSbhF b ： h ： S1 ： S2 ： 0.1 R- 100 . 4.7 (radioactivity) 4.7.1 (principle) . (MCA) . . 4.7.2 (apparatus) 4.7.2.1 (martinelli beakers) 1 L . 4.7.2.2 (ball mill) 4.7.2.3 (sieve) ASTM G136 03 . 4.7.2.4 (gamma spectrometry system) 20 % 25 % , 10 keV 10 MeV , 1.33 MeV 1.8 keV 2 keV (HPGe) . 4.7.2.5 (lea

17、d detector shield) (4.7.2.1) (1.6 mm) (0.4 mm) 5 cm 10 cm . 4.7.2.6 (multichannel analyser) 4 096 . 4.7.2.7 (appropriate software) KS P ISO 13356:2009 11 . . 4.7.3 (sample preparation) ASTM G 136 1.1 g/cm31.3 g/cm3 0.1m3 m . 1 L (4.7.2.1) . 4.7.4 (isotope identification) 4.7.4.1 (energy calibration)

18、 . 4 . CS137 4 . 1/3 CS137 662 keV 0.5 keV/channel . . 2 . 4.7.5 (quantitative analysis) 4.7.5.1 (efficiency calibration) 1 L . . 60 keV300 keV 50 keV , 300 keV1 400 keV 200 keV 1 400 keV 2 000 keV . 3 % . . KS P ISO 13356:2009 12 4 E (keV) / Na22950.4 d 511.00 1 274.54 1.807 0.999 4 Sc4683.80 d 889

19、.28 1 120.55 0.999 84 0.999 87 Cr5127.71 d 320.08 0.098 5 Mn54312.5 d 834.84 0.999 75 Co57271.84 d 122.06 136.47 0.855 9 0.105 8 Co601 925.5 d 1 173.24 1 332.50 0.999 0 0.999 824 Cd109436 d 88.03 0.036 8 Cs13730.0 a 661.66 0.850 Ce139137.65 d 165.853 0.800 Ce14132.50 d 145.44 0.489 Hg20346.612 d 279

20、.20 0.813 Am241420.0 a 59.54 0.360 4.7.5.2 (sample analysis) 1 L . . 4.7.6 (expression of results) Bg/kg . 4.7.7 (test report) . a) b) c) d) , KS P ISO 13356 4.8 (accelerated aging test) 4.8.1 (general) (對 ) . 4.3.7 4.4, 4.5 . KS P ISO 13356:2009 13 4.8.2 (procedure) 4.3.7 4.4 4.5 . 5 0.2 Mpa (1342)

21、 . , . 4.8.3 (evaluation of accelerated aging outcome) 4.3.7 . 4.4 4.5 . KS P ISO 13356:2009 14 1 ISO 12677, Chemical analysis of refractory products by XRF Fused cast bead method 2 DEVILLE, S., GREMILLARD, L., CHEVALIER, J. and FANTOZZI, G. Critical comparison of methods for the determination of aging sensitivity in biomedical Yttria Stabilized Zirconia, J. Biomed. Mater. Res., part B, applied biomaterials, Vol. 72.b, No. 2, pp. 239 245, 2005 3 GARVIE and NICHOLSON, J. Amer. Ceram. Soc., Vol. 55(6), pp.