IEC-6230200CheckList

1、IEC 62304Refer enceSoftware Lifecycle ProcessApplicable forCl ass ACl ass BCl ass CPRIMARY LIFECYCLE PROCESESS5SOFTWARE DEVELOPMENT Process5.1Development Planning Activity5.1.1Software development plan taskXXX5.1.2Software development plan reference to SYSTEM requirements taskXXX5.1.3SOUP management

2、 planning taskXX5.1.4Software development measures planning taskXX5.1.5Software integration and integration testing planning taskXX5.1.6Software VERIFICATION planning taskXXX5.1.7Software VERIFICATION requirements coverage planning taskXX5.1.8Software RISK MANAGEMENT planning taskXXX5.1.9Documentati

3、on planning 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 SYSTEM requirements taskXXX5.2.2Establish software re

4、quirements taskXXX5.2.3Software requirements content taskXXX5.2.4Include RISK CONTROL measures in software requirements taskXX5.2.5Update RISK ANALYSIS taskXXX5.2.6Ensure compliance with SYSTEM requirements taskXXX5.2.7Uniquely identify software requirements taskXXX5.2.8Update SYSTEM requirements ta

5、skXXX5.2.9Verify software requirements taskXXX5.2.10Document software requirements VERIFICATION taskXXX5.3Architectural Design Activity5.3.1Transform software requirements into anARCHITECTURE taskXXX5.3.2Document software ARCHITECTURE taskXXX5.3.3Document software safety classification of eachSOFTWA

6、RE ITEM taskXXX5.3.4Develop an ARCHITECTUREor the interfaces of SOFTWARE ITEMS taskXX5.3.5Specify SYSTEMhardware and software required by SOUP item taskXX5.3.6Specify functional and performance requirements of SOUP item taskXX5.3.7Identify segregation necessary for SAFETY taskXX5.3.8Verify software

7、ARCHITECTURE taskXX5.3.9Verify appropriateness of software development plan taskXX5.3.10Document results of software ARCHITECTUREVERIFICATION taskXX5.4Detailed Design Activity5.4.1Refine SOFTWAREITEMS into SOFTWAREUNITS taskXX5.4.2Inheritance of software safety classification taskXX5.4.3Develop deta

8、iled design for each SOFTWARE UNIT taskX5.4.4Develop 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 taskXX5.5.2Esta

9、blish SOFTWARE UNIT VERIFICATION PROCE taskSSXX5.5.3Verify software code taskXX5.5.4Additional software code VERIFICATION taskXX5.5.5Document the results of software codeVERIFICATION taskXX5.6Integration and Testing Activity5.6.1Integrate SOFTWARE UNITS taskXX5.6.2Verify software integration taskXX5

10、.6.3Document the results of software integration taskXX5.5.4Additional software code VERIFICATION taskXX5.6.5Integration testing content taskXX5.6.6Include integration testing for non-normal cases taskX5.6.7Conduct regression tests taskXX5.6.8Document results of software integration tests taskXX5.6.

11、9Integration test documentation contents taskXX5.6.10Use formal software problem resolution PROCESS taskXX5.7System Testing Activity5.7.1Establish tests for each software requirement taskXX5.7.2Use formal software problem resolution PROCESS taskXX5.7.3Repeat tests and conduct regression tests taskXX

12、5.7.4Verify SOFTWARE SYSTEM 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

13、.6Document how released 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

14、.1Record and evaluate feedback taskXXX6.2.2Use software problem resolution PROCESS taskXXX6.2.3Analyse modification requests taskXXX6.2.4Conduct analysis of changes implied by modification request taskXXX6.2.5Document new, modified and deleted item taskXXX6.2.6Review and approve modification taskXXX

15、6.2.7Document modification taskXX6.3Modification Implementation Activity6.3.1Use established PROCESS to implement modification taskXXX6.3.2Define criteria for testing modifications taskXX6.3.3Verify modifications taskXX6.3.4Conduct regression testing taskXX6.3.5Demonstrate software RISK CONTROL meas

16、ures remain effective taskXX6.3.6Document the test results taskXXseeArchitectural Design Activity5.3see5.4Detailed Design Activitysee5.5Software Coding Activitysee5.6Integration and Testing Activitysee5.7System Testing Activitysee5.8Release ActivitySUPPORTING PROCESSES7SOFTWARE RISK MANAGEMENT Proce

17、ss (referenced ISO 14971)7.1Analysis of software contributing to HAZARDSActivity7.1.1Identify SOFTWARE ITEMS that could contribute to a HAZARD taskXX7.1.2Identify potential causes of contribution to a HAZARD taskXX7.1.3Consider specific potential causes taskXX7.1.4Review published SOUP anomaly lists

18、 taskXX7.1.5Document potential causes taskXX7.1.6Document sequences of events taskXX7.2RISK CONTROL measures Activity7.2.1Define RISK CONTROL measures taskXX7.2.2RISK CONTROL measures implemented in software taskXX7.3VERIFICATION of RISK CONTROL measuresActivity7.3.1Verify RISK CONTROL measures task

19、XX7.3.2Document any new sequences of events taskXX7.3.3Document TRACEABILITY taskXX7.4RISK MANAGEMENT of software changes Activity7.4.1Analyse changes TO MEDICAL DEVICE SOFTWARE with respect to safety taskE XXX7.4.2Analyse impact software changes on existing RISK CONTROL measures taskXX7.4.3Perform

20、RISK MANAGEMENT ACTIVITIES based or analyses taskXX8SOFTWARE CONFIGURATION MANAGEMENTProcess8.1Configuration identification Activity8.1.1Establish means to identify CONFIGURATION ITEMS taskXXX8.1.2Identify SOUP taskXXX8.1.3Document SOUP designator taskXXX8.1.4Identify SYSTEM configuration documentation taskXXX8.2Configuration control Activity8.2.1Ident