{"id":198328,"date":"2024-10-19T12:37:32","date_gmt":"2024-10-19T12:37:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir62366-2-2016\/"},"modified":"2024-10-25T05:10:37","modified_gmt":"2024-10-25T05:10:37","slug":"aami-tir62366-2-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir62366-2-2016\/","title":{"rendered":"AAMI TIR62366 2 2016"},"content":{"rendered":"

This technical report contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a usability engineering (human factors engineering) process as defined in ANSI\/AAMI\/IEC 62366-1:2015.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/IEC TIR62366-2:2016, Medical devices\u2014Part 2: Guidance on the application of usability engineering to medical devices <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
ANSI Registration <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
11<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
12<\/td>\nCommittee representation <\/td>\n<\/tr>\n
14<\/td>\nBackground of AAMI adoption of IEC TR62366-2:2016 <\/td>\n<\/tr>\n
15<\/td>\nForeword <\/td>\n<\/tr>\n
17<\/td>\nIntroduction <\/td>\n<\/tr>\n
19<\/td>\n1 Scope and purpose
1.1 Scope
1.2 Purpose <\/td>\n<\/tr>\n
20<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n4 Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2
5 Background and justification of the usability engineering program
5.1 How safety relates to usability <\/td>\n<\/tr>\n
24<\/td>\nTable 1 \u2013 Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2 <\/td>\n<\/tr>\n
25<\/td>\n5.2 Reasons to invest in usability engineering
6 How to implement a usability engineering program
6.1 Effective usability engineering programs
6.2 Effective usability engineering projects and plans <\/td>\n<\/tr>\n
26<\/td>\n6.3 Apply an appropriate level of usability engineering expertise <\/td>\n<\/tr>\n
27<\/td>\n6.4 Ensure the necessary resources are available and well timed
6.5 Risk management as it relates to usability engineering
6.5.1 Risk analysis <\/td>\n<\/tr>\n
28<\/td>\n6.5.2 Risk control <\/td>\n<\/tr>\n
29<\/td>\n6.5.3 Information for safety <\/td>\n<\/tr>\n
31<\/td>\n6.5.4 Overall evaluation of residual risk
6.6 Usability engineering file <\/td>\n<\/tr>\n
32<\/td>\n6.7 Tailoring the usability engineering effort <\/td>\n<\/tr>\n
33<\/td>\n7 Overview of the usability engineering process <\/td>\n<\/tr>\n
34<\/td>\nFigure 1 \u2013 Example of a USABILITY ENGINEERING project for a graphical USER INTERFACE <\/td>\n<\/tr>\n
35<\/td>\n8 Prepare the use specification
8.1 Initiate use specification
8.2 Analyse the intended users, anticipated user tasks and intended use environments
8.2.1 Intended users <\/td>\n<\/tr>\n
37<\/td>\n8.2.2 Anticipated user tasks
8.2.3 Intended use environment <\/td>\n<\/tr>\n
38<\/td>\n8.3 Finalize the use specification <\/td>\n<\/tr>\n
39<\/td>\n8.4 Recommended methods for developing the use specification
8.4.1 General
8.4.2 Contextual inquiry and observation
8.4.3 Interview and survey techniques
8.4.4 Expert reviews
8.4.5 Advisory panel reviews <\/td>\n<\/tr>\n
40<\/td>\n8.4.6 Usability tests
9 Identify user interface characteristics related to safety and potential use errors
9.1 General
9.2 Task analysis <\/td>\n<\/tr>\n
41<\/td>\n9.3 Function analysis
Table 2 \u2013 Human versus machine capabilities <\/td>\n<\/tr>\n
42<\/td>\n9.4 Identify and analyse known problems <\/td>\n<\/tr>\n
43<\/td>\n10 Identify known or foreseeable hazards and hazardous situations
11 Identify and describe hazard-related use scenarios
11.1 Define use scenarios <\/td>\n<\/tr>\n
44<\/td>\n11.2 Use scenarios as they relate to risk management
11.3 Identify hazard-related use scenarios
11.4 Methods to define and analyse hazard-related use scenarios <\/td>\n<\/tr>\n
45<\/td>\n12 Select the hazard-related use scenarios for summative evaluation
12.1 General
12.2 Selection of the hazard-related use scenarios based on severity <\/td>\n<\/tr>\n
46<\/td>\nTable 3 \u2013 Example of five qualitative SEVERITY levels (adapted from Table D.3 of ISO 14971:2007)
12.3 Selection of hazard-related use scenarios based on other circumstances
13 Establish user interface specification
13.1 Development of the user interface specification <\/td>\n<\/tr>\n
47<\/td>\n13.2 Accompanying documentation and training <\/td>\n<\/tr>\n
48<\/td>\n14 Establish user interface evaluation plan
14.1 Specify how the user interface design will be explored and evaluated
14.2 Formative evaluation planning <\/td>\n<\/tr>\n
49<\/td>\n14.3 Summative evaluation planning
14.4 Usability test planning <\/td>\n<\/tr>\n
50<\/td>\n14.5 Example usability test protocol and report
Table 4 \u2013 Example outline of a USABILITY TEST protocol
Table 5 \u2013 Example outline of a USABILITY TEST report <\/td>\n<\/tr>\n
51<\/td>\n15 Design and implement the user interface and training
15.1 General <\/td>\n<\/tr>\n
52<\/td>\nFigure 2 \u2013 Progression of a USER INTERFACE design from multiple concepts to a few concepts to a preferred concept
15.2 Develop conceptual model(s) <\/td>\n<\/tr>\n
53<\/td>\n15.3 Design software user interfaces (if applicable)
15.3.1 General
15.3.2 Review user interface requirements and constraints
15.3.3 Develop software user interface structure(s)
15.3.4 Design wireframes <\/td>\n<\/tr>\n
54<\/td>\n15.3.5 Design screen templates
15.4 Design hardware user interfaces (if applicable)
15.4.1 General
15.4.2 Review user interface requirements and constraints <\/td>\n<\/tr>\n
55<\/td>\n15.4.3 Develop concept sketches
15.5 Design materials necessary for training and training
15.5.1 General
15.5.2 Training materials <\/td>\n<\/tr>\n
56<\/td>\nFigure 3 \u2013 Progression of concepts from multiple concepts to a few concepts to a preferred concept <\/td>\n<\/tr>\n
57<\/td>\n15.5.3 Training <\/td>\n<\/tr>\n
58<\/td>\n15.6 Develop detailed designs
15.7 Verify the design of the user interface
16 Perform formative evaluations
16.1 Conduct multiple formative evaluations <\/td>\n<\/tr>\n
59<\/td>\n16.2 Recommended methods for formative evaluation
16.2.1 General
16.2.2 Conduct heuristic analysis
16.2.3 Conduct cognitive walkthrough <\/td>\n<\/tr>\n
60<\/td>\n16.2.4 Conduct usability tests
16.3 Analysis of formative evaluation results <\/td>\n<\/tr>\n
61<\/td>\nTable 6 \u2013 USE ERRORS caused by sample USER INTERFACE design shortcomings
17 Perform summative evaluation
17.1 General <\/td>\n<\/tr>\n
62<\/td>\n17.2 Conduct a summative evaluation <\/td>\n<\/tr>\n
63<\/td>\n17.3 Data collection
17.3.1 General
17.3.2 Observational data
17.3.3 Subjective data
17.3.3.1 General <\/td>\n<\/tr>\n
64<\/td>\n17.3.3.2 Impression of the overall use of the medical device
17.3.3.3 Instances of confusion or difficulty
17.3.3.4 Use errors and close calls observed during simulated use testing
17.3.3.5 Close calls (not observed)
17.3.3.6 Knowledge task study data
17.4 Data analysis <\/td>\n<\/tr>\n
66<\/td>\nTable 7 \u2013 Sample USE ERRORS and their root causes
18 Document the usability engineering project
19 Post-production review and analysis <\/td>\n<\/tr>\n
69<\/td>\nAnnex A (informative) Recommended reading list <\/td>\n<\/tr>\n
71<\/td>\nAnnex B (informative) External resources to identify known problems
B.1 General
B.2 Austria
B.3 Germany <\/td>\n<\/tr>\n
72<\/td>\nB.4 Sweden
B.5 Switzerland
B.6 United Kingdom
B.7 United States <\/td>\n<\/tr>\n
73<\/td>\nAnnex C (informative) Developing usability goals for commercial purposes
C.1 General
C.2 Objective goals <\/td>\n<\/tr>\n
74<\/td>\nC.3 Subjective goals <\/td>\n<\/tr>\n
76<\/td>\nAnnex D (informative) Usability engineering project end products
Table D.1 \u2013 USABILITY ENGINEERING project end products (1 of 2) <\/td>\n<\/tr>\n
78<\/td>\nAnnex E (informative) Usability engineering methods
Table E.1 \u2013 Recommended application of USABILITY methods
E.1 General <\/td>\n<\/tr>\n
79<\/td>\nE.2 Advisory panel reviews <\/td>\n<\/tr>\n
80<\/td>\nE.3 Brainstorm use scenarios
E.4 Cognitive walkthrough
E.5 Contextual inquiry <\/td>\n<\/tr>\n
81<\/td>\nFigure E.1 \u2013 Sample of a USE ENVIRONMENT within a hospital
E.6 Day-in-the-life analysis <\/td>\n<\/tr>\n
82<\/td>\nE.7 Expert reviews
E.8 FMEA and FTA
E.9 Focus groups <\/td>\n<\/tr>\n
83<\/td>\nE.10 Function analysis
E.11 Heuristic analysis
E.12 Observation <\/td>\n<\/tr>\n
84<\/td>\nE.13 One-on-one interviews
E.14 Participatory design <\/td>\n<\/tr>\n
85<\/td>\nE.15 PCA analysis
Figure E.2 \u2013 Model of USER-MEDICAL DEVICE interaction <\/td>\n<\/tr>\n
86<\/td>\nE.16 Simulation
Figure E.3 \u2013 Infant manikin used in a neonatal care unit simulator (left), test participant simulating an auto-injector (centre) and an adult manikin used in a surgery SIMULATION (right) <\/td>\n<\/tr>\n
87<\/td>\nE.17 Standards reviews
E.18 Surveys
E.19 Task analysis <\/td>\n<\/tr>\n
88<\/td>\nFigure E.4 \u2013 Example hierarchical TASK ANALYSIS
E.20 Time-and-motion studies
E.21 Workload assessment <\/td>\n<\/tr>\n
89<\/td>\nAnnex F (informative) Usability engineering studies in clinical settings
F.1 General
F.2 Sample study in the clinical environment <\/td>\n<\/tr>\n
91<\/td>\nAnnex G (informative) User profile
Table G.1 \u2013 Sample USER PROFILE <\/td>\n<\/tr>\n
94<\/td>\nAnnex H (informative) Use environment descriptions
Table H.1 \u2013 Sample USE ENVIRONMENT <\/td>\n<\/tr>\n
96<\/td>\nAnnex I (informative) User interface requirements
Table I.1 \u2013 Sample USER INTERFACE REQUIREMENTS <\/td>\n<\/tr>\n
97<\/td>\nAnnex J (informative) Model the user interface
J.1 General
J.2 Develop preliminary prototype(s)
J.3 Develop a refined prototype <\/td>\n<\/tr>\n
98<\/td>\nFigure J.1 \u2013 USER INTERFACE designers using prototyping software to build and test a USER INTERFACE
J.4 Develop a specification prototype
J.5 Prepare a style guide <\/td>\n<\/tr>\n
99<\/td>\nAnnex K (informative) Usability test sample size <\/td>\n<\/tr>\n
100<\/td>\nFigure K.1 \u2013 Number of test participants needed in a USABILITY TEST for FORMATIVE EVALUATION <\/td>\n<\/tr>\n
101<\/td>\nTable K.1 \u2013 Cumulative probability of detecting a USABILITY problem <\/td>\n<\/tr>\n
102<\/td>\nAnnex L (informative) Identifying distinct user groups <\/td>\n<\/tr>\n
103<\/td>\nBibliography <\/td>\n<\/tr>\n
106<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/IEC TIR62366-2:2016 – Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n107<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198334,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198328","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198328","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198334"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198328"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198328"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198328"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}