KS P ISO 11953-2012 Dentistry－Implants－Clinical performance of hand torque instruments《牙科 植入 手扭矩仪器的临床性能评估》.pdf

1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 11953 KS P ISO 11953:2012 2012 9 17 http:/www.kats.go.krKS P ISO 11953:2012 : ( ) ( ) ( ) : (ISO/TC106) () () ( ) () () KS P ISO 11953:2012 : (http:/www.standard.go.kr) ： ：2012 9 17 2012-0423 ： ：(ISO/TC106) ( 02-509-7294) (http:/www.kats.go.kr). 10

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3、ry Implants Clinical performance of hand torque instruments 1 . , . , , . . 2 . . ( ) . KS P ISO 1942, ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices 3 KS P ISO 1942 . 3.1 , . 3.2 ( , , / ) 4 4.1 , KS P

4、ISO 11953:2012 2 . (screwdriver tip) . . 4.2 1 “ (break)” . (hinge) (clutch) . (locking) (cam) , a) b) (“ ”) , . . 4.3 2 1 “ (break)” . 4.4 3 1 “ (break)” (beam) . . 4.5 4 (customized contra-angle) (output shaft) - . - . . 5 6.2 “ (break)” . . . 7. d) 6 6.1 6.1.1 1, 2 . (hinge break mechanism) “ (br

5、eak)” (freedom) . KS P ISO 11953:2012 3 1 2 3 4 5 6 7 8 9 1 2 . 1 ： 1, 2, 3 KS P ISO 11953:2012 4 1 2 3 4 - 5 6 7 8 9 10 11 12 2 ： 4 . a) (6) (5). 20 N . b) (6) (7). 0.1 N cm5 % . , . (4) (8) (9) (3) , (6) . 4 KS P ISO 11953:2012 5 . (1) , 0.25 s-1(15 r/min) . (2) . . (101) N . . . 1： (break) 2： (2)

6、 3： 4： 6.1.2 . , . 6.1.3 . 6.2 6.2.1 6.2.1.1 1 4 . . . / 20 ( ) , . 6.2.2 . 6.2.1.2 2 3 , 1 . 3 ( , torque beam) , . 6.2.2 , ISO 17664 , 6.2.1 . . . . KS P ISO 11953:2012 6 7 , . a) b) ： , . c) d) e) f) KS P ISO 11953:2012 7 1 ISO 6789, Assembly tools for screws and nuts Hand torque tools Requiremen

7、ts and test methods for design conformance testing, quality conformance testing and recalibration procedure 2 KS P ISO 13402, , , 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 11953:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS DentistryImplants Clinical performance of hand torque instruments ICS 11.060.15