TABLE OF CONTENTS 1 Introduction 2 1.1 Document overview 2 1.2 Abbreviations and Glossary 2 1.2.1 Abbreviations 2 1.2.2 Glossary 2 1.3 References 2 1.3.1 Project References 2 1.3.2 Standard and regulatory References 3 1.4 Conventions 3 2 Use Specification 3 2.1 Description, intended use 3 2.2 Equipment application specification 4 2.2.1 Medical purpose 4 2.2.2 Patient population 4 2.2.3 Intended user 4 2.2.4 Application 4 3 Risk assessment 5 3.1 Characteristics related to safety 5 3.1.1 Primary operating functions and use scenarios 5 3.1.2 Possible Use errors 5 3.2 Hazardous phenomena, hazardous situations and hazard-related use scenarios 5 3.3 Hazard-related use scenarios for summative evaluation 5 3.4 Mitigation actions and the user interface specification 6 4 Formative Evaluations 6 5 Summative Evaluations 6 5.1 Summative Evaluation Protocol 6 5.2 Summative Evaluation Report 7 Introduction Document overview This document is the usability engineering file of XXX system/software. Abbreviations and Glossary Abbreviations Add here abbreviations Glossary Add here words definitions
TABLE OF CONTENTS 1 Introduction 2 1.1 Document overview 2 1.2 Abbreviations and Glossary 2 1.2.1 Abbreviations 2 1.2.2 Glossary 2 1.3 References 2 1.3.1 Project References 2 1.3.2 Standard and regulatory References 3 1.4 Conventions 3 2 Use Specification 3 2.1 Description, intended use 3 2.2 Equipment application specification 4 2.2.1 Medical purpose 4 2.2.2 Patient population 4 2.2.3 Intended user 4 2.2.4 Application 4 3 Risk assessment 5 3.1 Characteristics related to safety 5 3.1.1 Primary operating functions and use scenarios 5 3.1.2 Possible Use errors 5 3.2 Hazardous phenomena, hazardous situations and hazard-related use scenarios 5 3.3 Hazard-related use scenarios for summative evaluation 5 3.4 Mitigation actions and the user interface specification 6 4 Formative Evaluations 6 5 Summative Evaluations 6 5.1 Summative Evaluation Protocol 6 5.2 Summative Evaluation Report 7 Introduction Document overview This document is the usability engineering file of XXX system/software. Abbreviations and Glossary Abbreviations Add here abbreviations Glossary Add here words definitions
Usability-Engineering-File.docx