1、 56032null2014/ISO/TS 19218-2: 2012 2 ISO/TS 19218-2:2012 Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes (IDT) 560322014/ ISO/TS 19218-2:2012II1 ( ) - , 42 436 - 3 - 4 2014 . 501-4 IS/S 19218-2:2012 - . . 2. (ISO/TS 19218-2:2012 Medical devices Hierarchical
2、 coding structure for adverse events Part 2: Evaluation codes)5 1.02012 ( 8). ( 1 ) , -. () . , - (gost.ru) , 2014 , - - 560322014/ ISO/TS 19218-2:2012 III1 12 .13 24 2 () .14 15 560322014/ ISO/TS 19218-2:2012IV, , -, . , - ., , - , . - , , -, , :- ;- -. , .1 201501011 - , . , , . , , -, . , .2 :2.1
3、 (adverse event): , , , , , . 1 7. 2 , , . 3 , .2.2 (serious injury): , , , , , - . 1 , . 2 5. 560322014/ ISO/TS 19218-2:2012 2 Medical devices. Hierarchical coding structure for adverse events. Part 2. Evaluation codes 560322014/ ISO/TS 19218-2:201222.3 (intended use)/ (intended purpose): -, , . 4.
4、3 - . , 1. 1 , . 2 - . . 3 .4 1 . 1 1 2 25000 , 25001 - , -25002 - , - - - . 10993 ( )25003 - , , - 25004 -, - . - (. 2, 26503).25005 - , -, , . 10993 ( ) 560322014/ ISO/TS 19218-2:2012 3 1 2 25006 - - - . 10993 ( )25007 , - (, - )25008 - - - ( )25009 -, - , - -, 25100 , - -, - 25101 - - 25102 - , -
5、 - , 25300 - , - - -25301 - - -, 25302 - - 25303 25304 - - 1 560322014/ ISO/TS 19218-2:20124 1 2 25305 - - , -, , - -. - 62366, 3.17.25500 , , - - (, , - ), 25501 - (-, -, , -, -), . (. 2, 25506).25502 - - - , - , 25503 - , (, - , , -, )25504 , - (, - , ) , , -25505 , - , - -25506 , - , - 1 56032201
6、4/ ISO/TS 19218-2:2012 5 1 2 25507 -: - , - 25600 - , - - , - , (RFI)25601 - 25602 - - , - , - , - 26000 , - (-, , - -), , , , . - AAMI HE75.26001 - - - , - , , - , , . - 62366, 3.1.26002 - , 26003 , - 26004 , - -26005 - -, , , - (, , , , - in vitro ) 1 560322014/ ISO/TS 19218-2:20126 1 2 26006 - , 26007 - - -26008 - , - - -26009 /- , - - / 2
