1、 18192-1 2014 1 ISO 18192-1:2011 Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test (IDT) 2015 18192-12014 II 1 ( ) , 4 2 453 3 12 2014 . 2058- 4 18192-12011 . . 1.
2、(ISO 18192-1:2011 Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test) , A. 5 1.02012 ( 8). , . () . , (gost.ru). , 2015 , 18192-12014 1 1 Implants for surgery Wear o
3、f total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test 20160101 1 18192 , , . , . , , . . , , . , in vivo. , , , . , . 2 : 14242-2 . . 2. (ISO 14242-2, Implants for surgery Wear of total hip-joint
4、 prostheses Part 2: Methods of measurement) 3 . 3.1 (axial rotation): Z (. 1). 3.2 / (flexion/extension): Y (. 1). 3.3 (functional failure): , / . 3.4 (lateral bending): (. 1b). 3.5 (mechanical failure): . . 3.6 (origin): , . . 18192-12014 2 3.7 , (user-defined failure): , . 3.8 (X-axis): , . (. 1).
5、 3.9 Y (Y-axis): Y, . (. 1). 3.10 Z (Z-axis): Z, (. 1). 3.11 (cycle limit): , , . 4 , . . / - . , . ) / b) c) 1 5 5.1 , ( ) (20 2) /. 2 . . (, ). . 20 /. . . . . 8, k) 6). 5.2 , (, ), , - . , 18192-12014 3 , , . - , / , . . , . . ( ). . , (, ). 6 6.1 : , 1 2 3 , 2, (1 0,1) , , . 1 / . 7,546 . 7,5 4
6、6 . 32 2 . 6 22 , , . 2 , . 150 . 50 . 2 000 . 600 , , . , . (. 4). . , / . 1 , . , , , . 2 . 18192-12014 4 . 0 %, 25 %, 50 % 75 % , 6.4. . . : / . 3 ( ). , , . . 4 . X (%); Y (%); Z (); 1 /; 2 ; 3 ; 4 90 /, 180. 2 18192-12014 5 X (%); Y (); Z (); 1 /; 2 ; 3 ; 4 90 /, 180. 3 6.2 , , , , . 6.3 , , , , . , , . . Z 10 . . . 1 , , . , .
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