IEC/TR 62366-2:2016
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2:2016(E), which is a 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 both as defined in IEC 62366-1:2015 and as supporting goals other than SAFETY. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.
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CONTENTS
FOREWORD
INTRODUCTION
1 Scope and purpose
1.1 Scope
1.2 Purpose
2 Normative references
3 Terms and definitions
4 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
5.2 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
6.3 Apply an appropriate level of usability engineering expertise
6.4 Ensure the necessary resources are available and well timed
6.5 Risk management as it relates to usability engineering
6.5.1 Risk analysis
6.5.2 Risk control
6.5.3 Information for safety
6.5.4 Overall evaluation of residual risk
6.6 Usability engineering file
6.7 Tailoring the usability engineering effort
7 Overview of the usability engineering process
8 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
8.2.2 Anticipated user tasks
8.2.3 Intended use environment
8.3 Finalize the use specification
8.4 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
8.4.6 Usability tests
9 Identify user interface characteristics related to safety and potential use errors
9.1 General
9.2 Task analysis
9.3 Function analysis
9.4 Identify and analyse known problems
10 Identify known or foreseeable hazards and hazardous situations
11 Identify and describe hazard-related use scenarios
11.1 Define use scenarios
11.2 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
12 Select the hazard-related use scenarios for summative evaluation
12.1 General
12.2 Selection of the hazard-related use scenarios based on severity
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
13.2 Accompanying documentation and training
14 Establish user interface evaluation plan
14.1 Specify how the user interface design will be explored and evaluated
14.2 Formative evaluation planning
14.3 Summative evaluation planning
14.4 Usability test planning
14.5 Example usability test protocol and report
15 Design and implement the user interface and training
15.1 General
15.2 Develop conceptual model(s)
15.3 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
15.3.5 Design screen templates
15.4 Design hardware user interfaces (if applicable)
15.4.1 General
15.4.2 Review user interface requirements and constraints
15.4.3 Develop concept sketches
15.5 Design materials necessary for training and training
15.5.1 General
15.5.2 Training materials
15.5.3 Training
15.6 Develop detailed designs
15.7 Verify the design of the user interface
16 Perform formative evaluations
16.1 Conduct multiple formative evaluations
16.2 Recommended methods for formative evaluation
16.2.1 General
16.2.2 Conduct heuristic analysis
16.2.3 Conduct cognitive walkthrough
16.2.4 Conduct usability tests
16.3 Analysis of formative evaluation results
17 Perform summative evaluation
17.1 General
17.2 Conduct a summative evaluation
17.3 Data collection
17.3.1 General
17.3.2 Observational data
17.3.3 Subjective data
17.4 Data analysis
18 Document the usability engineering project
19 Post-production review and analysis
Annexes
Annex A (informative)Recommended reading list
Annex B (informative)External resources to identify known problems
B.1 General
B.2 Austria
B.3 Germany
B.4 Sweden
B.5 Switzerland
B.6 United Kingdom
B.7 United States
Annex C (informative)Developing usability goals for commercial purposes
C.1 General
C.2 Objective goals
C.3 Subjective goals
Annex D (informative)Usability engineering project end products
Annex E (informative)Usability engineering methods
E.1 General
E.2 Advisory panel reviews
E.3 Brainstorm use scenarios
E.4 Cognitive walkthrough
E.5 Contextual inquiry
E.6 Day-in-the-life analysis
E.7 Expert reviews
E.8 FMEA and FTA
E.9 Focus groups
E.10 Function analysis
E.11 Heuristic analysis
E.12 Observation
E.13 One-on-one interviews
E.14 Participatory design
E.15 PCA analysis
E.16 Simulation
E.17 Standards reviews
E.18 Surveys
E.19 Task analysis
E.20 Time-and-motion studies
E.21 Workload assessment
Annex F (informative)Usability engineering studies in clinical settings
F.1 General
F.2 Sample study in the clinical environment
Annex G (informative)User profile
Annex H (informative)Use environment descriptions
Annex I (informative)User interface requirements
Annex J (informative)Model the user interface
J.1 General
J.2 Develop preliminary prototype(s)
J.3 Develop a refined prototype
J.4 Develop a specification prototype
J.5 Prepare a style guide
Annex K (informative)Usability test sample size
Annex L (informative)Identifying distinct user groups
Bibliography
Index of defined terms
Figures
Figure 1 – Example of a usability engineering project for a graphical user interface
Figure 2 – Progression of a user interface design from multiple concepts to a few concepts to a preferred concept
Figure 3 – Progression of concepts from multiple concepts to a few concepts to a preferred concept
Figure E.1 – Sample of a use environment within a hospital
Figure E.2 – Model of user-medical device interaction
Figure E.3 – 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)
Figure E.4 – Example hierarchical task analysis
Figure J.1 – User interface designers using prototyping softwareto build and test a user interface
Figure K.1 – Number of test participants needed in a usability testfor formative evaluation
Tables
Table 1 – Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2
Table 2 – Human versus machine capabilities
Table 3 – Example of five qualitative severity levels(adapted from Table D.3 of ISO 14971:2007)
Table 4 – Example outline of a usability test protocol
Table 5 – Example outline of a usability test report
Table 6 – Use errors caused by sample user interface design shortcomings
Table 7 – Sample use errors and their root causes
Table D.1 – usability engineering project end products (1 of 2)
Table E.1 – Recommended application of usability methods
Table G.1 – Sample user profile (1 of 2)
Table H.1 – Sample use environment (1 of 2)
Table I.1 – Sample user interface requirements
Table K.1 – Cumulative probability of detecting a usability problem
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CONTENTS
FOREWORD
INTRODUCTION
1 Scope and purpose
1.1 Scope
1.2 Purpose
2 Normative references
3 Terms and definitions
4 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
5.2 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
6.3 Apply an appropriate level of usability engineering expertise
6.4 Ensure the necessary resources are available and well timed
6.5 Risk management as it relates to usability engineering
6.5.1 Risk analysis
6.5.2 Risk control
6.5.3 Information for safety
6.5.4 Overall evaluation of residual risk
6.6 Usability engineering file
6.7 Tailoring the usability engineering effort
7 Overview of the usability engineering process
8 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
8.2.2 Anticipated user tasks
8.2.3 Intended use environment
8.3 Finalize the use specification
8.4 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
8.4.6 Usability tests
9 Identify user interface characteristics related to safety and potential use errors
9.1 General
9.2 Task analysis
9.3 Function analysis
9.4 Identify and analyse known problems
10 Identify known or foreseeable hazards and hazardous situations
11 Identify and describe hazard-related use scenarios
11.1 Define use scenarios
11.2 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
12 Select the hazard-related use scenarios for summative evaluation
12.1 General
12.2 Selection of the hazard-related use scenarios based on severity
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
13.2 Accompanying documentation and training
14 Establish user interface evaluation plan
14.1 Specify how the user interface design will be explored and evaluated
14.2 Formative evaluation planning
14.3 Summative evaluation planning
14.4 Usability test planning
14.5 Example usability test protocol and report
15 Design and implement the user interface and training
15.1 General
15.2 Develop conceptual model(s)
15.3 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
15.3.5 Design screen templates
15.4 Design hardware user interfaces (if applicable)
15.4.1 General
15.4.2 Review user interface requirements and constraints
15.4.3 Develop concept sketches
15.5 Design materials necessary for training and training
15.5.1 General
15.5.2 Training materials
15.5.3 Training
15.6 Develop detailed designs
15.7 Verify the design of the user interface
16 Perform formative evaluations
16.1 Conduct multiple formative evaluations
16.2 Recommended methods for formative evaluation
16.2.1 General
16.2.2 Conduct heuristic analysis
16.2.3 Conduct cognitive walkthrough
16.2.4 Conduct usability tests
16.3 Analysis of formative evaluation results
17 Perform summative evaluation
17.1 General
17.2 Conduct a summative evaluation
17.3 Data collection
17.3.1 General
17.3.2 Observational data
17.3.3 Subjective data
17.4 Data analysis
18 Document the usability engineering project
19 Post-production review and analysis
Annexes
Annex A (informative)Recommended reading list
Annex B (informative)External resources to identify known problems
B.1 General
B.2 Austria
B.3 Germany
B.4 Sweden
B.5 Switzerland
B.6 United Kingdom
B.7 United States
Annex C (informative)Developing usability goals for commercial purposes
C.1 General
C.2 Objective goals
C.3 Subjective goals
Annex D (informative)Usability engineering project end products
Annex E (informative)Usability engineering methods
E.1 General
E.2 Advisory panel reviews
E.3 Brainstorm use scenarios
E.4 Cognitive walkthrough
E.5 Contextual inquiry
E.6 Day-in-the-life analysis
E.7 Expert reviews
E.8 FMEA and FTA
E.9 Focus groups
E.10 Function analysis
E.11 Heuristic analysis
E.12 Observation
E.13 One-on-one interviews
E.14 Participatory design
E.15 PCA analysis
E.16 Simulation
E.17 Standards reviews
E.18 Surveys
E.19 Task analysis
E.20 Time-and-motion studies
E.21 Workload assessment
Annex F (informative)Usability engineering studies in clinical settings
F.1 General
F.2 Sample study in the clinical environment
Annex G (informative)User profile
Annex H (informative)Use environment descriptions
Annex I (informative)User interface requirements
Annex J (informative)Model the user interface
J.1 General
J.2 Develop preliminary prototype(s)
J.3 Develop a refined prototype
J.4 Develop a specification prototype
J.5 Prepare a style guide
Annex K (informative)Usability test sample size
Annex L (informative)Identifying distinct user groups
Bibliography
Index of defined terms
Figures
Figure 1 – Example of a usability engineering project for a graphical user interface
Figure 2 – Progression of a user interface design from multiple concepts to a few concepts to a preferred concept
Figure 3 – Progression of concepts from multiple concepts to a few concepts to a preferred concept
Figure E.1 – Sample of a use environment within a hospital
Figure E.2 – Model of user-medical device interaction
Figure E.3 – 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)
Figure E.4 – Example hierarchical task analysis
Figure J.1 – User interface designers using prototyping softwareto build and test a user interface
Figure K.1 – Number of test participants needed in a usability testfor formative evaluation
Tables
Table 1 – Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2
Table 2 – Human versus machine capabilities
Table 3 – Example of five qualitative severity levels(adapted from Table D.3 of ISO 14971:2007)
Table 4 – Example outline of a usability test protocol
Table 5 – Example outline of a usability test report
Table 6 – Use errors caused by sample user interface design shortcomings
Table 7 – Sample use errors and their root causes
Table D.1 – usability engineering project end products (1 of 2)
Table E.1 – Recommended application of usability methods
Table G.1 – Sample user profile (1 of 2)
Table H.1 – Sample use environment (1 of 2)
Table I.1 – Sample user interface requirements
Table K.1 – Cumulative probability of detecting a usability problem