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

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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.

SectionTitleFulfilled in Document
4.1.1Usability Engineering ProcessSOP Integrated Software Development
4.1.2Risk Control as it relates to User Interface designRisk Table
4.1.3Information for Safety as it relates to UsabilityUsability Evaluation Report
4.2Usability Engineering FileUsability Evaluation Plan, Report
4.3Tailoring of the Usability Engineering effortUsability Evaluation Plan
5.1Prepare Use SpecificationSOP Integrated Software Development
5.2Identify User Interface characteristics related to Safety and potential Use ErrorsSoftware Requirements List
5.3Identify known or foreseeable Hazards and Hazardous SituationsRisk Table
5.4Identify and describe Hazard-Related Use ScenariosList of Hazard-Related Use Scenarios
5.5Select the Hazard-Related Use Scenarios for Summative EvaluationList of Hazard-Related Use Scenarios
5.6Establish User Interface SpecificationSoftware Requirements List
5.7.1Establish User Interface Evaluation Plan / GeneralUsability Evaluation Plan
5.7.2Formative Evaluation planningUsability Evaluation Plan
5.7.3Summative Evaluation planningUsability Evaluation Plan
5.8Perform User Interface design, implementation and Formative EvaluationSOP Integrated Software Development
5.9Perform Summative Evaluation of the Usability of the User InterfaceUsability Evaluation Protocol
5.10User Interface of Unknown Provenance(not applicable)

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