KS P ISO TR 11175-2010 Dental implants－Guidelines for developing dental implants《牙科植入物 研制牙科植入物指南》.pdf

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2、kr). 10 5 , . KS P ISO TR 11175:2010 i . . , , . , , . KS P ISO TR 11175:2010 Dental implantsGuidelines for developing dental implants 1993 1 ISO/TR 11175, Dental implantsGuidelines for developing dental implants . 1 , . . ( 5.1 5.2 ). 2 . . ( ) . KS P ISO 19421, 1： KS P ISO 7405, KS P ISO 10451, KS

3、 Q ISO 9001, ISO 6018：1987, Orthopaedic implantsGeneral requirements for marking, packaging and labelling ISO/TR 9966：1989, Implants for surgeryBiocompatibilitySelection of biological test methods for materials and devices 3 KS P ISO 19421 . 3.1 (dental implant) . ( ), ( ). KS P ISO 19421, 1.080 KS

4、P ISO TR 11175:2010 2 3.2 (transendodontic implant) (transradicular Implant) KS P ISO 19421, 1.081 3.3 (endosseous implant) 3.4 (fully embedded dental implant) 3.5 (transgingival transmucosal implant) 3.6 (subperiosteal implant) 3.7 (intramucosal implant) 3.8 (transosseous implant) 4 4.1 1 . 4.2 2 .

5、 A / B/B 1 / B 2 /B 3 / C/C 1 / C 2 /C 3 / X, Y Z 1 KS P ISO TR 11175:2010 3 A B 2 /B 3 / C 2 /C 3 / X , Y Z 2 5 5.1 5.1.1 . a) b) , c) d) e) f) 5.1.2 KS Q ISO 9001 , . a) , , , , b) b) , , , , , , 5.1.3 KS P ISO 10451 . 5.1.4 , , , . 5.2 5.2.1 . KS P ISO TR 11175:2010 4 a) b) , c) 5.2.2 KS P ISO 74

6、05 ISO/TR 9966 . 6 ISO/TC 194/WG4 ISO/TC 106/SC8/WG1 WG2 . 6.1 . . 6.2 , , . 6.3 . 7 , ISO 6018 , , . 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P ISO TR 11175 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Dental implants Guidelines for developing dental implants ICS 11.060.15 Korean Agency for Technology and Standards http:/www.kats.go.kr