医疗器械软件 软件生存周期过程 - nifdc.org.cn

1 ; YY/T0664 20XX YY/T0664 2008 Medicaldevices Softwarelifecycleprocesses IEC62304 2015 MOD 2019 4 12 XXXX-XX-XX XXXX-XX-XX YY/T0664 20 XXI ..VII ..IX1 .. * .. * ..12* ..23* ..24* .. * .. * .. * .. * ..95 .. * .. * .. * .. * .. * .. * .. * .. * ..186 .. * .. * .. * ..207* .. * ..228* .. * ..22YY/T0664 * .. * ..239* ..24 A ..25 B ..28 C ..41 D.

2 62 ..64 1 ..X 2 ..X 3 ..8 ( YY/T0316 2016 E)..31 ..32 (SOUP) ..34 ..42 V ..45 IEC61010-1 ..53 ..26 ..28 YY/T0287 2017 ..42 YY/T0316 2016 ..42 IEC60601-1 ..45 ISO/IEC12207 ..53 ..63YY/T0664 20 XXIII 2009 IEC62304 2015 IEC62304 2015 3 C GB/T19000 2016 ISO9000:2005( 3 YY/T0287 2017 ISO13485:2003 3 YY/T0316 2016 ISO14971.)

3 2007 3 ) ( ) C 1 IEC62304:2015 | YY/T0664 2008 YY/T0664 2008 IEC62304:2006/Amd1:2015 3 YY/T0664 20 XXIV.

4 IEC62304:2006/Amd1:2015 || (*) B A B C D SAC/TC221 YY/T0664 2008YY/T0664 20 XXV YY/T0316 YY/T0316

5 YY/T0316 1 5 2 6 8 9 YY/T0664 20 XXVI 1 2 YY/T0664 20 XXVII A B shall should may establish asappropriate YY/T0664 20XX1 1 * * 1 IEC82304-1[10]

6 ( ) EEPROM 2 ( ) 3 ( IEC60601-1 IEC82304-1 ) C 1 2 3 asappropriate 4 compliance GB/T8566 conformance 5 YY/T0664 20XX22* YY/T0316 ISO14971 2007.

7 IDT 3* activity anomaly IEEE1044 1993 architecture [ 1990] changerequest configurationitem ISO/IEC12207 2008 deliverable evaluation [ISO/IEC12207 2008 ]YY/T0664 harm [YY/T0316 2016 ] hazard [YY/T0316 2016 ] manufacturer / / 1 RA 2 GHTF 3 / ( )

8 4 5 6 7 / [YY/T0287 2017 ] medicaldevice 1 2 3 4 5 6 20XX4 medicaldevicesoftware problemreport 1 2 3 6 process 1

9 2 3 4 5 6 ISO/IEC 1 ISO SL ISO 1 5 [GB/T19000 2016 ] regressiontesting 1 [ISO/IEC12207 2017 ] risk [YY/T0316 2016 ] riskanalysis [YY/T0316 2016 ] riskcontrolYY/T0664 20XX5 [YY/T0316 2016 ] riskmanagement [YY/T0316 2016 ] riskmanagementfile [YY/T0316 2016 ] safety [YY/T0316 2016 ] security ISO/IEC12207 2017 seriousinjury.

10 A) b) c) softwaredevelopmentlifecyclemodel ISO12207 1995 softwareitem YY/T0664 20XX6 GB/T19003 2008 ISO/IEC12207 1995 softwaresystem softwareunit SOUP SOUP