[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-165670-en":3,"doc-seo-165670-105":31,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":21,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":15,"update_tm":29,"read_time":30},165670,687197207057,"Sage","https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0",1,17,"Forms","Usability Engineering File Template - Introduction","Usability Engineering File Template - Introduction provides a structured starting point for building the usability engineering documentation of an XXX system/software. It guides teams through document overview, abbreviations and glossary, references, and conventions, then moves into the Use Specification chapter. Readers define context of use for a medical device, identify intended use and patient population, describe intended users and application environment, and set up scenario structures used later for risk assessment and evaluation.","More templates to download on the:\n\u0013 HYPERLINK \"http://blog.cm-dm.com/pages/Software-Development-Process-templates\" \u0014Templates Repository for Software Development Process (click here)\u0015\nOr paste the link below in your browser address bar:\nhttp://blog.cm-dm.com/pages/Software-Development-Process-templates\nThis work is licensed under the:\nCreative Commons Attribution-NonCommercial-NoDerivs 3.0 France License: http://creativecommons.org/licenses/by-nc-nd/3.0/fr/\nWaiver:\nYou can freely download and fill the templates of blog.cm-dm.com, to produce technical documentation. The documents produced by filling the templates are outside the scope of the license. However, the modification of templates to produce new templates is in the scope of the license and is not allowed by this license.\nTo be compliant with the license, I suggest you to keep the following sentence at least once in the templates you store, or use, or distribute:\nThis Template is the property of Cyrille Michaud License terms: see http://blog.cm-dm.com/post/2011/11/04/License\nWho am I? See my linkedin profile:\nhttp://fr.linkedin.com/pub/cyrille-michaud/0/75/8b5\nYou can remove this first page when you’ve read it and acknowledged it!\nThank-you for downloading the\nUsability Engineering File Template!\n\u000f\nTABLE OF CONTENTS\n\u0013 TOC \\o \"1-3\" \u00141\tIntroduction\t\u0013 PAGEREF _Toc184976207 \\h \u00143\u0015\n1.1\tDocument overview\t\u0013 PAGEREF _Toc184976208 \\h \u00143\u0015\n1.2\tAbbreviations and Glossary\t\u0013 PAGEREF _Toc184976209 \\h \u00143\u0015\n1.2.1\tAbbreviations\t\u0013 PAGEREF _Toc184976210 \\h \u00143\u0015\n1.2.2\tGlossary\t\u0013 PAGEREF _Toc184976211 \\h \u00143\u0015\n1.3\tReferences\t\u0013 PAGEREF _Toc184976212 \\h \u00143\u0015\n1.3.1\tProject References\t\u0013 PAGEREF _Toc184976213 \\h \u00143\u0015\n1.3.2\tStandard and regulatory References\t\u0013 PAGEREF _Toc184976214 \\h \u00143\u0015\n1.4\tConventions\t\u0013 PAGEREF _Toc184976215 \\h \u00143\u0015\n2\tUse Specification\t\u0013 PAGEREF _Toc184976216 \\h \u00144\u0015\n2.1\tDescription, intended use\t\u0013 PAGEREF _Toc184976217 \\h \u00144\u0015\n2.2\tEquipment application specification\t\u0013 PAGEREF _Toc184976218 \\h \u00144\u0015\n2.2.1\tMedical purpose\t\u0013 PAGEREF _Toc184976219 \\h \u00144\u0015\n2.2.2\tPatient population\t\u0013 PAGEREF _Toc184976220 \\h \u00144\u0015\n2.2.3\tIntended user\t\u0013 PAGEREF _Toc184976221 \\h \u00144\u0015\n2.2.4\tApplication\t\u0013 PAGEREF _Toc184976222 \\h \u00144\u0015\n3\tRisk assessment\t\u0013 PAGEREF _Toc184976223 \\h \u00145\u0015\n3.1\tCharacteristics related to safety\t\u0013 PAGEREF _Toc184976224 \\h \u00145\u0015\n3.1.1\tPrimary operating functions and use scenarios\t\u0013 PAGEREF _Toc184976225 \\h \u00145\u0015\n3.1.2\tPossible Use errors\t\u0013 PAGEREF _Toc184976226 \\h \u00145\u0015\n3.2\tHazardous phenomena, hazardous situations and hazard-related use scenarios\t\u0013 PAGEREF _Toc184976227 \\h \u00146\u0015\n3.3\tCritical tasks\t\u0013 PAGEREF _Toc184976228 \\h \u00146\u0015\n3.4\tHazard-related use scenarios for summative evaluation\t\u0013 PAGEREF _Toc184976229 \\h \u00146\u0015\n3.5\tMitigation actions and the user interface specification\t\u0013 PAGEREF _Toc184976230 \\h \u00146\u0015\n4\tFormative Evaluations\t\u0013 PAGEREF _Toc184976231 \\h \u00146\u0015\n5\tSummative Evaluations\t\u0013 PAGEREF _Toc184976232 \\h \u00147\u0015\n5.1\tSummative Evaluation Protocol\t\u0013 PAGEREF _Toc184976233 \\h \u00147\u0015\n5.2\tSummative Evaluation Report\t\u0013 PAGEREF _Toc184976234 \\h \u00147\u0015\n\u0015\n\u000f\nIntroduction\nDocument overview\nThis document is the usability engineering file of XXX system/software.\nAbbreviations and Glossary\nAbbreviations\nAdd here abbreviations\nGlossary\nAdd here words definitions\nReferences\nProject References\nStandard and regulatory References\nConventions\nUse scenarios listed in this document are constructed according to the following structure:\nScenario Id\nScenario title\nScenario description, steps, alternative steps\nScenario version\nExample:\nSCN-XXX-000\nTitle of XXX-000 Scenario\nPrerequisite: software is in xxx state, user is willing to do xxx\nStep 1: Do This\nStep 2: Do that\nStep 2bis: Alternatively do that\nVersion of SCN-XXX-000\nUse Specification\nThis chapter aims at setting the context use of the medical device (who, what, how, where, when, why), to collect data that will be used to identify hazardous situations in the next chapter.\nThis chapter should be filled at the beginning of the project, before the specifications phase and before ","cbCaipFVW2Ql8kti","https://ap.wps.com/l/cbCaipFVW2Ql8kti","docx",152801,2,8,"English","en",105,"# Introduction\n## Document overview\n## Abbreviations and Glossary\n## References\n## Conventions\n# Use Specification\n## Description, intended use\n## Equipment application specification\n## Risk assessment\n## Formative Evaluations\n## Summative Evaluations","[{\"question\":\"What is the purpose of the Use Specification chapter in this template?\",\"answer\":\"It sets the context of use for the medical device to collect data used to identify hazardous situations in the next chapter. It is intended to be completed early in the project before specification and before user-validated mockups.\"},{\"question\":\"What information should be included when defining the patient population?\",\"answer\":\"Describe the patient population and provide relevant statistical information for usability, such as age and patient state (e.g., physical or mental disabilities) and level of instruction, especially when patients are the users.\"},{\"question\":\"How does the template approach risk assessment?\",\"answer\":\"It structures risk assessment around safety-related characteristics, primary operating functions and use scenarios, possible use errors, hazardous phenomena and situations, critical tasks, and mitigation actions linked to the user interface specification.\"}]","Usability Engineering File Template - Introduction | DOCX",1788175095,3,{"code":4,"msg":32,"data":33},"ok",{"site_id":25,"language":24,"slug":34,"title":14,"keywords":35,"description":15,"schema_data":36,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":29},"usability-engineering-file-template-introduction","",{"@graph":37,"@context":85},[38,53,68],{"@type":39,"itemListElement":40},"BreadcrumbList",[41,45,48,50],{"item":42,"name":43,"@type":44,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":46,"name":47,"@type":44,"position":21},"https://docshare.wps.com/template/","Template",{"item":49,"name":13,"@type":44,"position":30},"https://docshare.wps.com/template/forms/",{"item":51,"name":14,"@type":44,"position":52},"https://docshare.wps.com/template/usability-engineering-file-template-introduction/165670/",4,{"url":51,"name":14,"@type":54,"author":55,"headline":14,"publisher":57,"fileFormat":60,"inLanguage":24,"description":15,"dateModified":61,"datePublished":62,"encodingFormat":60,"isAccessibleForFree":63,"interactionStatistic":64},"DigitalDocument",{"name":9,"@type":56},"Person",{"url":42,"name":58,"@type":59},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-02","2026-08-31",true,{"@type":65,"interactionType":66,"userInteractionCount":21},"InteractionCounter",{"@type":67},"ViewAction",{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"What is the purpose of the Use Specification chapter in this template?","Question",{"text":75,"@type":76},"It sets the context of use for the medical device to collect data used to identify hazardous situations in the next chapter. It is intended to be completed early in the project before specification and before user-validated mockups.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"What information should be included when defining the patient population?",{"text":80,"@type":76},"Describe the patient population and provide relevant statistical information for usability, such as age and patient state (e.g., physical or mental disabilities) and level of instruction, especially when patients are the users.",{"name":82,"@type":73,"acceptedAnswer":83},"How does the template approach risk assessment?",{"text":84,"@type":76},"It structures risk assessment around safety-related characteristics, primary operating functions and use scenarios, possible use errors, hazardous phenomena and situations, critical tasks, and mitigation actions linked to the user interface specification.","https://schema.org",{"og:url":51,"og:type":87,"og:title":14,"og:site_name":58,"og:description":15},"article",{"robots":89,"canonical":51},"index,follow",{"doc_id":7,"site_id":25},{"code":4,"msg":5,"data":92},[93,98,103,108,113,118,121,126,131],{"id":94,"doc_module":11,"doc_module_name":47,"category_name":95,"show_sort_weight":96,"slug":97},11,"Presentations",90,"presentations",{"id":99,"doc_module":11,"doc_module_name":47,"category_name":100,"show_sort_weight":101,"slug":102},12,"Resumes",80,"resumes",{"id":104,"doc_module":11,"doc_module_name":47,"category_name":105,"show_sort_weight":106,"slug":107},14,"Invoices",70,"invoices",{"id":109,"doc_module":11,"doc_module_name":47,"category_name":110,"show_sort_weight":111,"slug":112},15,"Posters",60,"posters",{"id":114,"doc_module":11,"doc_module_name":47,"category_name":115,"show_sort_weight":116,"slug":117},16,"Social Media",50,"social-media",{"id":12,"doc_module":11,"doc_module_name":47,"category_name":13,"show_sort_weight":119,"slug":120},40,"forms",{"id":122,"doc_module":11,"doc_module_name":47,"category_name":123,"show_sort_weight":124,"slug":125},18,"Letters",30,"letters",{"id":127,"doc_module":11,"doc_module_name":47,"category_name":128,"show_sort_weight":129,"slug":130},21,"Paper Templates",5,"papers-templates",{"id":132,"doc_module":11,"doc_module_name":47,"category_name":133,"show_sort_weight":4,"slug":134},158,"General","general-158"]