KS P ISO 14801-2013 Dentistry－Implants－Dynamic fatigue test for endosseous dental implants《牙科学 植入物 骨质牙科植入物的动态疲劳试验》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 14801 KS P ISO 14801:2013 2013 5 16 http:/www.kats.go.krKS P ISO 14801:2013 : ( ) ( ) ( ) : (ISO/TC106) () ( ) () () () () () () KS P ISO 14801:2013 : (http:/www.standard.go.kr) ： ：2008 9 30 ：2013 5 16 2013-0177 ： ： (ISO/TC106) ( 02-509-7294) (http:

2、/www.kats.go.kr). 10 5 , . KS P ISO 14801:2013 i ii . iii 1 1 2 1 3 .1 4 .2 4.1 .2 4.2 .2 4.3 - 2 5 2 5.1 2 5.2 2 5.3 5 5.4 6 5.5 .6 5.6 .6 6 .6 A( ) - .8 9 KS P ISO 14801:2013 ii . KS P ISO 14801:2008 . KS P ISO 14801:2013 iii 2007 2 ISO 14801, Dentistry Implants Dynamic fatigue test for endosseous

3、 dental implants . KS P ISO 14801:2013 Dentistry Implants Dynamic fatigue test for endosseous dental implants 1 . . , , . 2 . . ( ) . KS B ISO 1099, KS B ISO 4965, KS B ISO 7500 1, 1： / KS P ISO 1942, 3 KS P ISO 1942 . 3.1 (endosseous dental implant system) , 1 . 2 . 3 . KS P ISO 14801:2013 2 3.2 -

4、load-cycle diagram) A 4 4.1 ( , ). , . , . 4.2 . . , 5 % . . 4.3 - / , . . 5 5.1 . 5 % (KS B ISO 7500 1 KS B ISO 4965 ) , 5.2 5.2.1 ( 1 2) . ( 1 2 C ) , y , KS P ISO 14801:2013 3 5.2.2 , 1 . ： mm 1 (5.2.6 ). 2 (5.3.2 ) 3 4 5 6 1 5.2.3 302 ( 1 ). 5.2.4 . 2 +1210 . 1 . . 11 mm( 2 l ) . KS P ISO 14801

5、2013 4 ： mm 1 ( (5.2.6 ). 2 (5.3.2 ) 3 4 5 6 2 5.2.5 F . , C , . . 5.2.6 . KS P ISO 14801:2013 5 . . 50 mm . 5.2.7 , . , . 5.2.8 , . . 5.3 5.3.1 - . 3 GPa . 5.2 . . 5.3.2 3.0 mm0.5 mm ( 1, 2 ). , . , . 3.0 mm . 5.3.3 (pre-angled) , 5.2.4 (l) 11.0 mm0.5 mm ( 1 2 ). arm, y l sin 30 . , arm 0.5l 5.5 m

6、m . l 11 mm l . . (M) . M yF 1 M 0.5lF l 11 mm F N M 5.5F (N mm) 5.3.4 , . , 2 , KS P ISO 14801:2013 6 (l) 11.0 mm0.5 mm ( 2 ). arm y( 2 ) . (l) 11 mm l . . . M yF N mm . 5.4 , , . 37 2 . 20 5 . . 5.5 . 10 % (sine) . 15 Hz . 2 Hz . 5.6 5.6.1 KS B ISO 1099 . 5.6.2 3 ( ) - . 2 Hz 2106 , 2 Hz 5106 . 80

7、 % . , A . 4 , 2 , 3 . ( 1 2 C) . 5.6.3 . , . 5106 2 Hz 2106 - . 3 . 5.3.3 5.3.4 , M . 6 , , 6.1.1 6.1.15 . 6.1.1 , KS P ISO 14801:2013 7 (： , , ) ：- , , - (taper-fit), , ( ) , (geometric dimensions) , 6.1.2 6.1.3 6.1.4 / (4.3 ), 6.1.5 (5.2.8 ), 6.1.6 arm, y 6.1.7 arm 6.1.8 . , 6.1.9 l 11.0 mm (5.3.

8、3 5.3.4 ), l 6.1.10 6.1.11 , 6.1.12 6.1.13 6.1.14 ( , ) 6.1.15 ( A ) - 5106 2 Hz 2106 ( ) , , M(5.6.3 ) KS P ISO 14801:2013 8 A ( ) - , . . ( ) ( ) . - ( A.1 ). - , ( , nF) . . LF , nF 5106 2 Hz 2106 . X , N Y (N) ： , ： 37 , ： 2 Hz, nF： 2106 A.1 2106 - KS P ISO 14801:2013 9 1 ASTM E 466-96, Standard

9、 Practice for Conducting Force Controlled Constant Amplitude Axial Fatigue Tests of Metallic Materials 2 ASTM E 468-90, Standard Practice for Presentation of Constant Amplitude Fatigue Test Results for Metallic Materials 3 ISO 6892, Metallic materials Tensile testing Method of testing at ambient tem

10、perature 4 KS P ISO 7206 4, 4： 5 KS P ISO 10451, 6 United States of America, Food and Drug Administration, Center for Devices and Radiological Health, Class ll Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments Guidance for Industry and FDA Staff, 2004-05-12 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 14801:2013 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS DentistryImplantsDynamic fatigue test for endosseous dental implants ICS 11.060.15