IEC 62304 Class A/B/C 등급별 요구사항 정리

 

5.1 Software Development Planning
Clause	내용	Class A	Class B	Class C
5.1.1	Software development plan	✔	✔	✔
5.1.2	Keep software development plan updated	✔	✔	✔
5.1.3	Reference to system D&D	✔	✔	✔
5.1.4	Development standards, methods, tools planning	✖	✖	✔
5.1.5	Integration & integration test planning	✖	✔	✔
5.1.6	Software verification planning	✔	✔	✔
5.1.7	Software risk management planning	✔	✔	✔
5.1.8	Documentation planning	✔	✔	✔
5.1.9	Configuration management planning	✔	✔	✔
5.1.10	Supporting items control	✖	✔	✔
5.1.11	Configuration item control before verification	✔	✔	✔
5.1.12	Avoid common software defects	✖	✔	✔
5.2 Software Requirement Analysis
Clause	내용	Class A	Class B	Class C
5.2.1	Define software requirements from system requirements	✔	✔	✔
5.2.2	Software requirements content	✔	✔	✔
5.2.3	Include risk control measures	✖	✔	✔
5.2.4	Re-evaluate medical device risk analysis	✔	✔	✔
5.2.5	Update requirements	✔	✔	✔
5.2.6	Verify software requirements	✔	✔	✔
5.3 Software Architectural Design
Clause	내용	Class A	Class B	Class C
5.3.1	Transform requirements into architecture	✖	✔	✔
5.3.2	Develop architecture for interfaces	✖	✔	✔
5.3.3	Specify SOUP functional/performance requirements	✖	✔	✔
5.3.4	Specify hardware & software required by SOUP	✖	✔	✔
5.3.5	Identify segregation for risk control	✖	✖	✔
5.3.6	Verify software architecture	✖	✔	✔
5.4 Software Detailed Design
Clause	내용	Class A	Class B	Class C
5.4.1	Subdivide into software units	✖	✔	✔
5.4.2	Develop detailed design for each unit	✖	✖	✔
5.4.3	Develop interface design	✖	✖	✔
5.4.4	Verify detailed design	✖	✖	✔
5.5 Software Unit Implementation
Clause	내용	Class A	Class B	Class C
5.5.1	Implement each software unit	✔	✔	✔
5.5.2	Establish unit verification process	✖	✔	✔
5.5.3	Unit acceptance criteria	✖	✔	✔
5.5.4	Additional acceptance criteria	✖	✖	✔
5.5.5	Software unit verification	✖	✔	✔
5.6 Software Integration & Integration Testing
Clause	내용	Class A	Class B	Class C
5.6.1	Integrate software units	✖	✔	✔
5.6.2	Verify integration	✖	✔	✔
5.6.3	Integration testing	✖	✔	✔
5.6.4	Integration testing content	✖	✔	✔
5.6.5	Evaluate test procedures	✖	✔	✔
5.6.6	Regression tests	✖	✔	✔
5.6.7	Integration test records	✖	✔	✔
5.6.8	Problem resolution process	✖	✔	✔
5.7 Software System Testing
Clause	내용	Class A	Class B	Class C
5.7.1	Establish tests for requirements	✔	✔	✔
5.7.2	Use problem resolution process	✔	✔	✔
5.7.3	Retest after changes	✔	✔	✔
5.7.4	Evaluate system testing	✔	✔	✔
5.7.5	System test record contents	✔	✔	✔
5.8 Software Release
Clause	내용	Class A	Class B	Class C
5.8.1	Ensure verification complete	✔	✔	✔
5.8.2	Document residual anomalies	✔	✔	✔
5.8.3	Evaluate residual anomalies	✔	✔	✔
5.8.4	Document released version	✔	✔	✔
5.8.5	Document build process	✖	✔	✔
5.8.6	Ensure tasks complete	✖	✔	✔
5.8.7	Archive software	✔	✔	✔
5.8.8	Assure delivery reliability	✖	✔	✔