1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 22803 KS P ISO 22803:2013 2013 5 16 http:/www.kats.go.krKS P ISO 22803:2013 : ( ) ( ) ( ) : (ISO/TC106) () ( ) () () () () () () KS P ISO 22803:2013 : (http:/www.standard.go.kr) ： ：2008 9 30 ：2013 5 16 2013-0177 ： ： (ISO/TC106) ( 02-509-7294) (http:
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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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5、cal devices Application of risk management to medical devices EN 1041, Information supplied by the manufacturer with medical devices 3 KS P ISO 1942 . 3.1 (periodontal tissue) , , , 3.2 (biocompatibility) 3.3 (biocompatibility) 3.4 (biomaterial) , , , 3.5 (biomaterial) , / . 3.6 (membrane material)
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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
