1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 10451 KS P ISO 10451:2012 2012 9 14 http:/www.kats.go.krKS P ISO 10451:2012 : ( ) ( ) () ( ) : (ISO/TC106) () () ( ) KS P ISO 10451:2012 : (http:/www.standard.go.kr) ： ：2003 12 30 ：2012 9 14 2012-0418 ： ：(ISO/TC106) ( 02-509-7294) (http:/www.kats.go
2、.kr). 10 5 , . KS P ISO 10451:2012 i ii . iii 1 1 2 1 3 .2 4 2 4.1 2 4.2 .2 4.3 2 4.4 .3 4.5 .3 4.6 .4 4.7 4 4.8 .4 4.9 4 4.10 4 4.11 4 4.12 4 4.13 .5 4.14 .5 4.15 5 7 KS P ISO 10451:2012 ii . KS P ISO 10451： 2008 . KS P ISO 10451:2012 iii 2010 2 ISO 10451, Dentistry Contents of technical file for d
3、ental implant systems . KS P ISO 10451:2012 Dentistry Contents of technical file for dental implant systems 1 . 2 . . ( ) . KS P ISO 1942, KS P ISO 7405, KS P ISO 10993 1, 1： KS P ISO 10993 7, 7： KS P ISO 10993 9, 9： KS P ISO 11137 1 1： , KS P ISO 11137 2, 2： KS P ISO 11137 3, 3： KS P ISO 11607 1, 1
4、： , KS P ISO 11607 2, 2： , KS P ISO 14155 1, 1： KS P ISO 14155 2, 2： KS P ISO 14801, KS P ISO 14937, , , KS P ISO 17665 1, 1： , KS P ISO TS 22911, KS P ISO 10451:2012 2 KS X ISO 8601, ISO 129 1, Technical drawings Indication of dimensions and tolerances Part 1： General principles ISO 11135 1, Steril
5、ization of health care productsEthylene oxide Part 1 ： Requirements for development, validation and routine control of a sterilization process for medical devices ISO/TS 11135 2, Sterilization of health care productsEthylene oxide Part 2： Guidance on the application of ISO 11135 1 ISO 14405 2, Geome
6、trical product specifications (GPS)Dimensional tolerancing Part 2： Dimensions other than linear sizes ISO 14971, Medical devices Application of risk management to medical devices ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resteril
7、izable medical devices 3 KS P ISO 1942 . 3.1 / 3.2 , 3.3 . . 3.4 4 4.1 4.24.15 . . . 4.2 . . 4.3 KS P ISO 10451:2012 3 . a) . b) . ISO 129 1 ISO 14405 2 . c) , . 4.4 . a) 1) ( 100 % ) 2) 3) 4) 5) 6) , 7) , , b) 1) 2) ( ) 3) ( ) 4) 5) c) 1) 1.1) ( , ) 1.2) 1.3) 1.4) (%) 1.5) 2) ( ) 2.1) 2.2) 3) 3.1)
8、3.2) KS M ISO 178 . 4.5 . KS P ISO 10451:2012 4 a) KS P ISO 14801 b) , c) . 4.9 . d) KS P ISO 10993 1 4.6 , . 4.7 ISO 14971 . 4.8 . a) . . b) ( ) . , , ISO 11135 1, ISO/TS 11135 2 KS P ISO 10993 7 . KS P ISO 11137 1, KS P ISO 11137 2 KS P ISO 11137 3 , ISO 14937 . 4.9 . KS P ISO 7405, KS P ISO 10993
9、 1 KS P ISO TS 22911 . ( KS P ISO 5832 2, KS P ISO 5832 3, KS P ISO 6474 KS P ISO 13356 .) . 4.10 . KS P ISO 14155 1 KS P ISO 14155 2 . 4.11 . . . 4.12 KS P ISO 10451:2012 5 . 4.13 4.13.1 1 1 . KS P ISO 11607 1 KS P ISO 11607 2 . . . 4.13.2 , ( , ) . 4.14 . . a) , b) c) “ ” , KS X ISO 8601 . d) ( ,
10、, , ) e) KS X ISO 8601 f) , g) h) i) , . , . 4.15 . a) 4.14 c), d) e) b) c) d) e) f) g) h) ( , ) KS P ISO 10451:2012 6 i) j) k) l) , “ ” KS P ISO 10451:2012 7 1 KS M ISO 178, 2 KS P ISO 5832 2, 2： 3 KS P ISO 5832 3, 3： 6- 4- 4 KS P ISO 6474, 5 ISO 6507 1, Metallic materials Vickers hardness test Par
11、t 1： Test method 6 ISO 6892 1, Metallic materials Tensile testing Part 1： Method of test at room temperature 7 KS Q ISO 9001, 8 KS P ISO 13356, (Y-TZP) 9 KS P ISO 13485, 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO 10451:2012 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS DentistryContents of technical file for dental implant systems ICS 11.060.15 Korean Agency for Technology and Standards http:/www.kats.go.kr
