Checklist Xls: Iec 62304

A static XLS file becomes obsolete quickly. To truly succeed, treat your IEC 62304 Excel checklist as a living document.

Recommended workflow:

Advanced Excel Tricks:

| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | Analysis | | | | | | D1 | 5.1.1 | Are input requirements defined? | Capture functional, interface, and performance requirements. | SRS Document | | D2 | 5.1.2 | Are requirements traceable? | Each requirement needs a unique ID. | Traceability Matrix | | D3 | 5.1.3 | Is the content of the SRS complete? | Must include functional, safety, security, and user interface requirements. | Approved SRS | | Design | | | | | | D4 | 5.2 | Has the software architecture been documented? | Define system components, interfaces, and data flows. | Architecture Diagrams | | D5 | 5.3.1 | Has the software detailed design been developed? (Class B/C) | Refine architecture to the unit level. | Detailed Design Docs | | D6 | 5.3.4 | Is there a correspondence between requirements and design? | Verify that every requirement is covered by the design. | Traceability Matrix | | Implementation | | | | | | D7 | 5.4 | Is source code implemented according to design? | Developers must follow coding standards defined in Q2. | Source Code Repo | | D8 | 5.4.2 | Are contributions to the architecture/design recorded? | If coding reveals a design flaw, update the design docs. | Change Request | | Testing | | | | | | D9 | 5.5 | Are Unit Tests defined and executed? (Class B/C) | Test each software unit (function/class) in isolation. | Unit Test Reports | | D10 | 5.6 | Is Integration Testing performed? | Verify interfaces between units/modules. | Integration Test Report | | D11 | 5.7 | Is System Testing performed? | Test against the SRS requirements in the target environment. | System Test Report | | D12 | 5.7.4 | Are regression tests performed after changes? | Ensure changes did not break existing functionality. | Regression Test Report |

Post-market surveillance.

Testing the interfaces between modules.

This is the core content for the spreadsheet. It outlines the specific activities required by the standard. Iec 62304 Checklist Xls

| Column A | Column B | |----------|----------| | Safety Class | A, B, C (based on possible harm) | | Clause Ref | IEC 62304 clause number | | Required | Yes / No / Conditional | | Verification | Not started / In progress / Done / N/A |

Requirements must be uniquely identifiable, testable, and traceable to Risk Management (ISO 14971). A static XLS file becomes obsolete quickly

| Activity | Sub-activity | Class A | Class B | Class C | Method | Traceability | Status | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | Unit verification | Test cases | ✘ | ✔ | ✔ | Automated/Manual | → Design spec | | | | Coverage (MC/DC) | ✘ | ✘ | ✔ | Analysis | | | | Integration verification | Interface testing | ✘ | ✔ | ✔ | Black/gray box | → Architecture | | | System testing | Functional testing | ✔ | ✔ | ✔ | Manual/Auto | → SRS | | | | Performance testing | ✘ | ✔ | ✔ | Benchmark | | | | | Stress/load testing | ✘ | ✘ | ✔ | Simulation | | | | Regression testing | After change | ✔ | ✔ | ✔ | Selective/full | → Change log | |