Template: IEC 62366-1 2015 Mapping of Requirements to Documents

This table correlates the requirements from IEC 62366-1:2015 (organized by section) to their respective documents.

Please note that the document titles in the “Fulfilled in Document” column are based on OpenRegulatory templates. You may have a different naming convention for your documents, so feel free to adjust them as needed.

Section Title Fulfilled in Document
4.1.1 Usability Engineering Process SOP Integrated Software Development
4.1.2 Risk Control related to User Interface design Risk Table
4.1.3 Information for Safety related to Usability Usability Evaluation Report
4.2 Usability Engineering File Usability Evaluation Plan, Report
4.3 Tailoring the Usability Engineering effort Usability Evaluation Plan
5.1 Preparing the Use Specification SOP Integrated Software Development
5.2 Identifying User Interface characteristics tied to Safety and Potential Use Errors Software Requirements List
5.3 Identifying known or anticipated Hazards and Hazardous Situations Risk Table
5.4 Identifying and detailing Hazard-Related Use Scenarios List of Hazard-Related Use Scenarios
5.5 Selecting Hazard-Related Use Scenarios for Summative Evaluation List of Hazard-Related Use Scenarios
5.6 Establishing User Interface Specification Software Requirements List
5.7.1 Creating a User Interface Evaluation Plan / General Usability Evaluation Plan
5.7.2 Planning Formative Evaluation Usability Evaluation Plan
5.7.3 Planning Summative Evaluation Usability Evaluation Plan
5.8 Conducting User Interface design, implementation, and Formative Evaluation SOP Integrated Software Development
5.9 Performing Summative Evaluation of User Interface Usability Usability Evaluation Protocol
5.10 User Interface of Unknown Provenance (not applicable)

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