1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 15223 , KS P ISO 15223： 2007(2012 ) 2007 12 6 http:/www.kats.go.krKS P ISO 15223： 2007 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 10 31 ：2007 12 6 ：2012 12 6 ： 20120679 ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 15223： 200
2、7 i .1 1 1 2 .1 3 2 A( ) 6 8 KS P ISO 15223： 2007 (2012 ) , Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 2000 2 ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied , . 1 . . ( )
3、( ) , , . , . KS P IEC 60601 1 . 2 . . KS P ISO 15223： 2007 2 , . 2.1 (information essential for proper use) , , . . . 2.2 (transition period) , 3 , 1 . 1 3.1 3.2 3.3 a3.4 , b, c KS P ISO 15223： 2007 3 1 ( ) 3.5 , 3.6 3.7 3.8 3.9 3.10 3.11 3.12 dKS P ISO 15223： 2007 4 1 ( ) 3.13 e 3.14 (batch) 3.15
4、3.16 3.17 f 3.18 g 3.19 h 3.20 KS P ISO 15223： 2007 5 1 ( ) 3.21 3.22 3.23 3.24 a . 3.4 b . 3.3 c . (A.2 ). d , . , . KS X ISO 8601 e . , , . KS X ISO 8601 f . g 3.17 . h 3.17 . KS P ISO 15223： 2007 6 A ( ) A.1 ISO ISO/TC 145 KS A ISO 7000 . ISO/TC 145 IEC/TC 3 . IEC/TC 3 IEC 60417 1 . . ISO/TC 145
5、ISO . , KS A ISO 7000 . ISO/TC 210 , KS A ISO 7000 . EN 980 . EN 980 KS A ISO 7000 . ISO/TC 210 . A.2 . , . , 75 % . “ ” “ ” . . CENT/TC 52 EN 71 6 . A.3 . ISO ISO/TC 210 . , , ISO 3461 1 . KS P ISO 15223： 2007 7 . ISO/TC 210 , KS A ISO 7000 ISO/TC 145 . . KS P ISO 15223： 2007 8 1 KS A ISO 780, 2 IS
6、O 3461 1： 1988, General principles for the creation of graphical symbols Part 1： Graphical symbols for use on equipment 3 KS A ISO 7000, 4 KS X ISO 8601, 5 IEC 60417 1： 1998, Graphical symbols for use on equipment Part 1： Overview and application 6 KS P IEC 60601 1, 7 EN 71 6： 1994, Safety of toys P
7、art 6： Graphical symbols for age warning labelling 8 EN 980： 1996, Graphical symbols for use in the libelling of medical devices , 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ KS P ISO 15223： 2007 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Medical devicesSymbols to be used with medical device labels, labelling and information to be supplied ICS 01.080.99 ; 11.040.01 Korean Agency for Technology and Standards http:/www.kats.go.kr
