IEC-62304-2006-CheckList(最新整理)

1、iec 62304refer encesoftware lifecycle processapplicableforcl as sacl as sbcl as scprimary lifecycle procesess5software development process5.1development planning activity5.1.1software development plan taskxxx5.1.2software development plan reference to systemrequirements taskxxx5.1.3soup management p

2、lanning taskxx5.1.4software development measures planning taskxx5.1.5software integration and integration testingplanning taskxx5.1.6software verification planning taskxxx5.1.7software verification requirements coverageplanning taskxx5.1.8software risk management planning taskxxx5.1.9documentation p

3、lanning taskxxx5.1.10software configuration management planning taskxxx5.1.11software configuration control planning taskxx5.1.12software problem resolution planning taskx5.2requirements analysis activity5.2.1define software requirements from systemrequirements taskxxx5.2.2establish software require

4、ments taskxxx5.2.3software requirements content taskxxx5.2.4include risk control measures in softwarerequirements taskxx5.2.5update risk analysis taskxxx5.2.6ensure compliance with system requirementstaskxxx5.2.7uniquely identify software requirements taskxxx5.2.8update system requirements taskxxx5.

5、2.9verify software requirements taskxxx5.2.10document software requirements verificationtaskxxx5.3architectural design activity5.3.1transformsoftwarerequirementsintoanarchitecture taskxxx5.3.2document software architecture taskxxx5.3.3document software safety classification of eachsoftware item task

6、xxx5.3.4develop an architecture for the interfaces ofsoftware items taskxx5.3.5specify system hardware and software requiredby soup item taskxx5.3.6specify functional and performance requirementsof soup item taskxx5.3.7identify segregation necessary for safety taskxx5.3.8verify software architecture

7、 taskxx5.3.9verify appropriateness of software developmentplan taskxx5.3.10document results of software architectureverification taskxx5.4detailed design activity5.4.1refine software items into software unitstaskxx5.4.2inheritance of software safety classification taskxx5.4.3develop detailed design

8、for each software unittaskx5.4.4develop detailed design for interfaces taskx5.4.5verify detailed design taskxx5.4.6additional detailed design verification taskx5.4.7document results of design verification taskxx5.5software coding activity5.5.1implement each software unit taskxx5.5.2establish softwar

9、e unit verification processtaskxx5.5.3verify software code taskxx5.5.4additional software code verification taskxx5.5.5documenttheresultsofsoftwarecodeverification taskxx5.6integration and testing activity5.6.1integrate software units taskxx5.6.2verify software integration taskxx5.6.3document the re

10、sults of software integration taskxx5.5.4additional software code verification taskxx5.6.5integration testing content taskxx5.6.6include integration testing for non-normal casesxtask5.6.7conduct regression tests taskxx5.6.8document results of software integration teststaskxx5.6.9integration test doc

11、umentation contents taskxx5.6.10use formal software problem resolution processtaskxx5.7system testing activity5.7.1establish tests for each software requirement taskxx5.7.2use formal software problem resolution processtaskxx5.7.3repeat tests and conduct regression tests taskxx5.7.4verify software sy

12、stem testing taskxx5.7.5record data for each test taskxx5.8release activity5.8.1ensure software verification is completexx5.8.2ensure documentation is completexx5.8.3document known residual anomaliesxx5.8.4evaluate known residual anomaliesxx5.8.5document released versionsxx5.8.6document how released

13、 software was createdxx5.8.7archive master copiesxx5.8.8use established procedures for software releasexx6software maintenance process6.1establish software maintenance plan activity6.1.1establish software maintenance plan taskxxx6.2problem and modification analysis activity6.2.1record and evaluate f

14、eedback taskxxx6.2.2use software problem resolution process taskxxx6.2.3analyse modification requests taskxxx6.2.4conductanalysisofchangesimpliedbymodification request taskxxx6.2.5document new, modified and deleted item taskxxx6.2.6review and approve modification taskxxx6.2.7document modification ta

15、skxx6.3modification implementation activity6.3.1useestablishedprocesstoimplementmodification taskxxx6.3.2define criteria for testing modifications taskxx6.3.3verify modifications taskxx6.3.4conduct regression testing taskxx6.3.5demonstrate software risk control measuresremain effective taskxx6.3.6do

16、cument the test results taskxxsee5.3architectural design activitysee5.4detailed design activitysee5.5software coding activitysee5.6integration and testing activitysee5.7system testing activitysee5.8release activitysupporting processes7softwareriskmanagementprocess(referenced iso 14971)7.1analysis of

17、 software contributing to hazardsactivity7.1.1identify software items that could contribute toa hazardtaskxx7.1.2identify potential causes of contribution to ahazard taskxx7.1.3consider specific potential causes taskxx7.1.4review published soup anomaly lists taskxx7.1.5document potential causes task

18、xx7.1.6document sequences of events taskxx7.2risk control measures activity7.2.1define risk control measures taskxx7.2.2risk control measures implemented in softwaretaskxx7.3verificationofriskcontrolmeasuresactivity7.3.1verify risk control measures taskxx7.3.2document any new sequences of events tas

19、kxx7.3.3document traceability taskxx7.4risk management of software changes activity7.4.1analyse changes to medical device softwarewith respect to safety taskxxx7.4.2analyse impact software changes on existing riskcontrol measures taskxx7.4.3perform risk management activities based onanalyses taskxx8

20、softwareconfigurationmanagementprocess8.1configuration identification activity8.1.1establish means to identify configurationitems taskxxx8.1.2identify soup taskxxx8.1.3document soup designator taskxxx8.1.4identify system configuration documentation taskxxx8.2configuration control activity8.2.1identi

21、fy and record change requests taskxxx8.2.2approve requests prior to implementation taskxxx8.2.3implement changes taskxxx8.2.4provide means for traceability of change taskxxx8.3configuration status accounting activity8.3.1configuration status accounting taskxxx9software problem resolution processsoft

22、ware problem resolution activity9.1.1prepare problem reports taskxxx9.1.2advise relevant parties taskxxx9.1.3investigate the problem taskxxx9.1.4evaluate the problems relevance to safety taskxxx9.1.5track and report status taskxxx9.1.6resolve the problem taskxxx9.1.7maintain a record of the problem taskxxx9.1.8analyse problems for tre