A quality checklist clearly indicates which clauses apply to each safety class. For example, section 5.3.5—"Identify segregation necessary for SAFETY task"—applies only to software, not Classes B and C. Your XLS should reflect these distinctions.
Has final system testing been performed against software requirements? Are test results documented and approved? 8. Software Release (Clause 5.8) Is there a procedure for releasing the software? Are release notes and user documentation complete? Tailoring the Checklist: Software Safety Class Iec 62304 Checklist Xls
Identify software-specific hazards and document risk control measures (must align with Software Configuration Management (Clause 8): A quality checklist clearly indicates which clauses apply
| Class | Definition (Risk of Injury to Patient/Operator) | Documentation Requirement | | :--- | :--- | :--- | | | No possible injury. | Basic Documentation | | Class B | Possible non-serious injury. | Standard Documentation | | Class C | Possible serious injury or death. | Rigorous Documentation | Has final system testing been performed against software
Before diving into the checklist, you must understand the three software safety classes (A, B, C) established by IEC 62304.