KS P ISO 22803-2013 Dentistry－Membrane materials for guided tissue regeneration in oral and maxillofacial surgery－Contents of a technical file《牙科学 口腔及颌面外科中受控制的组织再生用薄膜材料 技术文档的内容》.pdf

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3、llofacial surgery Contents of a technical file . KS P ISO 22803:2013 Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file 1 , , - , , . / / , , , . 2 . . ( ) . KS P ISO 1942, 1)KS P ISO 10993 1, 1： KS P ISO 10993 7, 7： KS P ISO 11

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6、, / . 3.7 (barrier) , / KS P ISO 22803:2013 3 3.8 (packing) . 3.9 (augmentation) / , - . 3.10 (resorbable) / 3.11 (tissue regeneration) , 3.12 (guided tissue regeneration) GTR , , . 3.13 (guided bone regeneration) GBR GTR 4 , : a) b) c) d) e) , , , . , , , , , ( ) . . , , . KS P ISO 22803:2013 4 5 5

7、.1 . a) b) c) d) , , e) 5.2 KS P ISO 10993 13, KS P ISO 10993 14, KS P ISO 10993 15 KS P ISO 10993 18 . . 5.3 . ： , - ： ( , .) (： ) (： ) , . 5.4 5.4.1 ISO 14971 , GTR / GBR . . . 5.4.2 KS P ISO 22803:2013 5 . . , , . KS P ISO 10993 1 . , , , . , , / . , . 5.4.3 . . a) , / b) , , / , KS P ISO 14155 1

8、 . 5.5 . . 5.6 5.6.1 10 6 . . KS P ISO 11135 , KS P ISO 11137 1 KS P ISO 11137 3 , KS P ISO 17665 1 , KS P ISO 14937 . , KS P ISO 22803:2013 6 . - , . , (5.8 ) . 5.6.2 KS P ISO 10993 1 . KS P ISO 10993 7 . 5.7 5.7.1 , . , ( , , ) , , . . 5.7.2 , . , KS P ISO 11607 1 KS P ISO 11607 2 . 5.8 5.8.1 EN 1

9、041 . , KS P ISO 15223 . . , / . . 5.8.2 , . 5.8.3 , . KS P ISO 22803:2013 7 ( ) ( ) ( ) KS P ISO 22803:2013 8 1 KS P ISO 1942, 2 KS P ISO 10993 2, 2： 3 KS P ISO 10993 3, 3： , , 4 KS P ISO 10993 4, 4： 5 KS P ISO 10993 5, 5： 6 KS P ISO 10993 6, 6： 7 KS P ISO 10993 9, 9： 8 KS P ISO 10993 10, 10： 9 KS

10、P ISO 10993 11, 11： 10 KS P ISO 10993 12, 12： 11 KS P ISO 10993 13, 13： 12 KS P ISO 10993 14, 14： 13 KS P ISO 10993 15, 15： 14 KS P ISO 10993 18, 18： 15 KS P ISO 13408 1, 1： 16 ISO 14160, Sterilization of single-use medical devices incorporating materials of animal originValidation and routine contr

11、ol of sterilization by liquid chemical sterilants 17 KS P ISO TR 14283, 18 KS P ISO 14630, 19 EN 980, Graphical symbols for use in the labelling of medical devices 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 22803:2013 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS DentistryMembrane materials for guided tissue regeneration in oral and maxillofacial surgeryContents of a technical file ICS 11.060.15