AAMI TIR62366 2 2016
$162.84
AAMI/IEC TIR62366-2:2016 – Medical Devices Part 2: Guidance on the Application of Usability Engineering to Medical Devices.
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 107 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/IEC TIR62366-2:2016, Medical devices—Part 2: Guidance on the application of usability engineering to medical devices |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Registration |
| 6 | Contents |
| 11 | Glossary of equivalent standards |
| 12 | Committee representation |
| 14 | Background of AAMI adoption of IEC TR62366-2:2016 |
| 15 | Foreword |
| 17 | Introduction |
| 19 | 1 Scope and purpose 1.1 Scope 1.2 Purpose |
| 20 | 2 Normative references 3 Terms and definitions |
| 23 | 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 |
| 24 | Table 1 – Mapping between the requirements of IEC 62366-1 and the guidance of IEC TR 62366-2 |
| 25 | 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 |
| 26 | 6.3 Apply an appropriate level of usability engineering expertise |
| 27 | 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 |
| 28 | 6.5.2 Risk control |
| 29 | 6.5.3 Information for safety |
| 31 | 6.5.4 Overall evaluation of residual risk 6.6 Usability engineering file |
| 32 | 6.7 Tailoring the usability engineering effort |
| 33 | 7 Overview of the usability engineering process |
| 34 | Figure 1 – Example of a USABILITY ENGINEERING project for a graphical USER INTERFACE |
| 35 | 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 |
| 37 | 8.2.2 Anticipated user tasks 8.2.3 Intended use environment |
| 38 | 8.3 Finalize the use specification |
| 39 | 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 |
| 40 | 8.4.6 Usability tests 9 Identify user interface characteristics related to safety and potential use errors 9.1 General 9.2 Task analysis |
| 41 | 9.3 Function analysis Table 2 – Human versus machine capabilities |
| 42 | 9.4 Identify and analyse known problems |
| 43 | 10 Identify known or foreseeable hazards and hazardous situations 11 Identify and describe hazard-related use scenarios 11.1 Define use scenarios |
| 44 | 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 |
| 45 | 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 |
| 46 | Table 3 – 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 |
| 47 | 13.2 Accompanying documentation and training |
| 48 | 14 Establish user interface evaluation plan 14.1 Specify how the user interface design will be explored and evaluated 14.2 Formative evaluation planning |
| 49 | 14.3 Summative evaluation planning 14.4 Usability test planning |
| 50 | 14.5 Example usability test protocol and report Table 4 – Example outline of a USABILITY TEST protocol Table 5 – Example outline of a USABILITY TEST report |
| 51 | 15 Design and implement the user interface and training 15.1 General |
| 52 | Figure 2 – Progression of a USER INTERFACE design from multiple concepts to a few concepts to a preferred concept 15.2 Develop conceptual model(s) |
| 53 | 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 |
| 54 | 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 |
| 55 | 15.4.3 Develop concept sketches 15.5 Design materials necessary for training and training 15.5.1 General 15.5.2 Training materials |
| 56 | Figure 3 – Progression of concepts from multiple concepts to a few concepts to a preferred concept |
| 57 | 15.5.3 Training |
| 58 | 15.6 Develop detailed designs 15.7 Verify the design of the user interface 16 Perform formative evaluations 16.1 Conduct multiple formative evaluations |
| 59 | 16.2 Recommended methods for formative evaluation 16.2.1 General 16.2.2 Conduct heuristic analysis 16.2.3 Conduct cognitive walkthrough |
| 60 | 16.2.4 Conduct usability tests 16.3 Analysis of formative evaluation results |
| 61 | Table 6 – USE ERRORS caused by sample USER INTERFACE design shortcomings 17 Perform summative evaluation 17.1 General |
| 62 | 17.2 Conduct a summative evaluation |
| 63 | 17.3 Data collection 17.3.1 General 17.3.2 Observational data 17.3.3 Subjective data 17.3.3.1 General |
| 64 | 17.3.3.2 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 |
| 66 | Table 7 – Sample USE ERRORS and their root causes 18 Document the usability engineering project 19 Post-production review and analysis |
| 69 | Annex A (informative) Recommended reading list |
| 71 | Annex B (informative) External resources to identify known problems B.1 General B.2 Austria B.3 Germany |
| 72 | B.4 Sweden B.5 Switzerland B.6 United Kingdom B.7 United States |
| 73 | Annex C (informative) Developing usability goals for commercial purposes C.1 General C.2 Objective goals |
| 74 | C.3 Subjective goals |
| 76 | Annex D (informative) Usability engineering project end products Table D.1 – USABILITY ENGINEERING project end products (1 of 2) |
| 78 | Annex E (informative) Usability engineering methods Table E.1 – Recommended application of USABILITY methods E.1 General |
| 79 | E.2 Advisory panel reviews |
| 80 | E.3 Brainstorm use scenarios E.4 Cognitive walkthrough E.5 Contextual inquiry |
| 81 | Figure E.1 – Sample of a USE ENVIRONMENT within a hospital E.6 Day-in-the-life analysis |
| 82 | E.7 Expert reviews E.8 FMEA and FTA E.9 Focus groups |
| 83 | E.10 Function analysis E.11 Heuristic analysis E.12 Observation |
| 84 | E.13 One-on-one interviews E.14 Participatory design |
| 85 | E.15 PCA analysis Figure E.2 – Model of USER-MEDICAL DEVICE interaction |
| 86 | E.16 Simulation 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) |
| 87 | E.17 Standards reviews E.18 Surveys E.19 Task analysis |
| 88 | Figure E.4 – Example hierarchical TASK ANALYSIS E.20 Time-and-motion studies E.21 Workload assessment |
| 89 | Annex F (informative) Usability engineering studies in clinical settings F.1 General F.2 Sample study in the clinical environment |
| 91 | Annex G (informative) User profile Table G.1 – Sample USER PROFILE |
| 94 | Annex H (informative) Use environment descriptions Table H.1 – Sample USE ENVIRONMENT |
| 96 | Annex I (informative) User interface requirements Table I.1 – Sample USER INTERFACE REQUIREMENTS |
| 97 | Annex J (informative) Model the user interface J.1 General J.2 Develop preliminary prototype(s) J.3 Develop a refined prototype |
| 98 | Figure J.1 – 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 |
| 99 | Annex K (informative) Usability test sample size |
| 100 | Figure K.1 – Number of test participants needed in a USABILITY TEST for FORMATIVE EVALUATION |
| 101 | Table K.1 – Cumulative probability of detecting a USABILITY problem |
| 102 | Annex L (informative) Identifying distinct user groups |
| 103 | Bibliography |
| 106 | Index of defined terms |
