1、 62304null2013 . IEC 62304:2006 Medical device software Software life cycle processes (IDT) 623042013II1 , 42 436 - 3 - 8 2013 . 1492-4 62304:2006 - . (IEC 62304:2006 Medical device software Software life cycle processes). - 1.5 ( 3.5). - , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 , - - 623
2、042013III1 .11.1* 11.2* 11.3 11.4 12* 23* .24* 54.1* 54.2* .54.3 . .55 65.1* 65.2* 85.3 .105.4* 115.5* .115.6* 125.7* 135.8* .146 146.1 .146.2* 156.3* 157* .167.1* , 167.2 .167.3 .177.4 178* 188.1* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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4、2007. . 1 5. -, , - , - . . - 2 6. 623042013VI 1 2 623042013VII , - . ( 8) ( 9). , - . , , . , , -, . , , - , . . - , . A . B - . :- ;- , , -;- , -;- , ; - , , - , , , , , , - .1 2015null1null1 1 1.1* - . , , - , .1.2* . - , , - . - , - .1.3 - - . . 1.4 , - , , . , , , . , , , , -, . (. D). 62304201
5、3 . Medical devices. Software. Life cycle processes 6230420132 1 . 2 , , . 3 , , , - . 4 , / 12207, - .2* : 14971:2007 . - (ISO 14971:2007, Medical devices Application of risk management to medical devices)3* :3.1 (ACTIVITY): - . 3.2 (ANOMALY): , , , - , . . - . , , , -, . IEEE 1044:1993, 3.13.3 (ARCHITECTURE): .IEEE 610.12:19903.4 (CHANGE REQUEST): -, .3.5 (CONFIGURATION ITEM): , - . / 12207, 3.6.3.6 (DELIVERABLE): ( -) .3.7 (EVALUATION): ./ 12207:1999, 3.93.8 (HARM): , ./ 51:1999, 3.33.9 (HAZARD): . / 51:1999, 3.53.10 (MANUFACTURER): , , , /
