OpenRegulatory Template

IEC 62366-1:2015 Mapping of Requirements to Documents

This table maps all requirements of the IEC 62366-1:2015 (by section) to the relevant documents.

Note that the document names in the “Fulfilled in Document” column are based on the OpenRegulatory templates. You’ll probably have a different system for assigning document names, so feel free to rename them.

Section Title Fulfilled in Document
4.1.1 Usability Engineering Process SOP Integrated Software Development
4.1.2 Risk Control as it relates to User Interface design Risk Table
4.1.3 Information for Safety as it relates to Usability Usability Evaluation Report
4.2 Usability Engineering File Usability Evaluation Plan, Report
4.3 Tailoring of the Usability Engineering effort Usability Evaluation Plan
5.1 Prepare Use Specification SOP Integrated Software Development
5.2 Identify User Interface characteristics related to Safety and potential Use Errors Software Requirements List
5.3 Identify known or foreseeable Hazards and Hazardous Situations Risk Table
5.4 Identify and describe Hazard-Related Use Scenarios List of Hazard-Related Use Scenarios
5.5 Select the Hazard-Related Use Scenarios for Summative Evaluation List of Hazard-Related Use Scenarios
5.6 Establish User Interface Specification Software Requirements List
5.7.1 Establish User Interface Evaluation Plan / General Usability Evaluation Plan
5.7.2 Formative Evaluation planning Usability Evaluation Plan
5.7.3 Summative Evaluation planning Usability Evaluation Plan
5.8 Perform User Interface design, implementation and Formative Evaluation SOP Integrated Software Development
5.9 Perform Summative Evaluation of the Usability of the User Interface Usability Evaluation Protocol
5.10 User Interface of Unknown Provenance (not applicable)

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