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.
This publication is to be read in conjunction with IEC 62366-1:2015.

General Information

• Status: Published
• Publication Date: 26-Apr-2016
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 4 - TC 62/SC 62A/JWG 4
• Current Stage: PPUB - Publication issued
• Start Date: 31-Jul-2016
• Completion Date: 27-Apr-2016

Standards Content (Sample)

IEC TR 62366-2
Edition 1.0 2016-04
TECHNICAL
REPORT
colour
inside
Medical devices –
Part 2: Guidance on the application of usability engineering to medical devices
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IEC TR 62366-2
Edition 1.0 2016-04
TECHNICAL
REPORT
colour
inside
Medical devices –
Part 2: Guidance on the application of usability engineering to medical devices

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-3346-7

– 2 – IEC TR 62366-2:2016 © IEC 2016
CONTENTS
FOREWORD . 6
INTRODUCTION . 8
1 Scope and purpose . 9
1.1 Scope . 9
1.2 Purpose . 9
2 Normative references. 10
3 Terms and definitions . 11
4 Mapping between the requirements of IEC 62366-1 and the guidance of
IEC TR 62366-2 . 14
5 Background and justification of the USABILITY ENGINEERING program . 14
5.1 How SAFETY relates to USABILITY . 14
5.2 Reasons to invest in USABILITY ENGINEERING . 15
6 How to implement a USABILITY ENGINEERING program . 16
6.1 Effective USABILITY ENGINEERING programs . 16
6.2 Effective USABILITY ENGINEERING projects and plans . 16
6.3 Apply an appropriate level of USABILITY ENGINEERING expertise . 17
6.4 Ensure the necessary resources are available and well timed . 18
6.5 RISK MANAGEMENT as it relates to USABILITY ENGINEERING . 18
6.5.1 RISK ANALYSIS . 18
6.5.2 RISK CONTROL . 19
6.5.3 Information for SAFETY . 20
6.5.4 Overall evaluation of RESIDUAL RISK . 22
6.6 USABILITY ENGINEERING FILE . 22
6.7 Tailoring the USABILITY ENGINEERING effort . 23
7 Overview of the USABILITY ENGINEERING PROCESS . 24
8 Prepare the USE SPECIFICATION . 27
8.1 Initiate USE SPECIFICATION . 27
8.2 Analyse the intended USERS, anticipated USER TASKS and intended USE
ENVIRONMENTS . 28
8.2.1 Intended USERS . 28
8.2.2 Anticipated USER TASKS . 30
8.2.3 Intended USE ENVIRONMENT . 30
8.3 Finalize the USE SPECIFICATION . 30
8.4 Recommended methods for developing the USE SPECIFICATION . 31
8.4.1 General . 31
8.4.2 Contextual inquiry and observation . 31
8.4.3 Interview and survey techniques . 31
8.4.4 Expert reviews . 32
8.4.5 Advisory panel reviews . 32
8.4.6 USABILITY TESTS . 32
9 Identify USER INTERFACE characteristics related to SAFETY and potential USE
ERRORS . 32
9.1 General . 32
9.2 TASK ANALYSIS . 33
9.3 FUNCTION ANALYSIS . 33
9.4 Identify and analyse known problems . 35

10 Identify known or foreseeable HAZARDS and HAZARDOUS SITUATIONS . 35
11 Identify and describe HAZARD-RELATED USE SCENARIOS . 36
11.1 Define USE SCENARIOS . 36
11.2 USE SCENARIOS as they relate to RISK MANAGEMENT . 36
11.3 Identify HAZARD-RELATED USE SCENARIOS . 37
11.4 Methods to define and analyse HAZARD-RELATED USE SCENARIOS . 37
12 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION . 38
12.1 General . 38
12.2 Selection of the HAZARD-RELATED USE SCENARIOS based on SEVERITY . 39
12.3 Selection of HAZARD-RELATED USE SCENARIOS based on other circumstances . 39
13 Establish USER INTERFACE SPECIFICATION . 40
13.1 Development of the USER INTERFACE SPECIFICATION . 40
13.2 ACCOMPANYING DOCUMENTATION and training . 40
14 Establish USER INTERFACE EVALUATION plan . 41
14.1 Specify how the USER INTERFACE design will be explored and evaluated . 41
14.2 FORMATIVE EVALUATION planning . 42
14.3 SUMMATIVE EVALUATION planning . 42
14.4 USABILITY TEST planning . 43
14.5 Example USABILITY TEST protocol and report . 43
15 Design and implement the USER INTERFACE and training . 44
15.1 General . 44
15.2 Develop conceptual model(s). 46
15.3 Design software USER INTERFACES (if applicable) . 47
15.3.1 General . 47
15.3.2 Review USER INTERFACE REQUIREMENTS and constraints . 47
15.3.3 Develop software USER INTERFACE structure(s) . 47
15.3.4 Design wireframes . 48
15.3.5 Design screen templates . 48
15.4 Design hardware USER INTERFACES (if applicable) . 48
15.4.1 General . 48
15.4.2 Review USER INTERFACE REQUIREMENTS and constraints . 49
15.4.3 Develop concept sketches . 49
15.5 Design materials necessary for training and training . 49
15.5.1 General . 49
15.5.2 Training materials . 49
15.5.3 Training . 51
15.6 Develop detailed designs . 52
15.7 Verify the design of the USER INTERFACE . 52
16 Perform FORMATIVE EVALUATIONS . 52
16.1 Conduct multiple FORMATIVE EVALUATIONS . 52
16.2 Recommended methods for FORMATIVE EVALUATION . 53
16.2.1 General . 53
16.2.2 Conduct heuristic analysis . 54
16.2.3 Conduct cognitive walkthrough . 54
16.2.4 Conduct USABILITY TESTS . 54
16.3 Analysis of FORMATIVE EVALUATION results . 55
17 Perform SUMMATIVE EVALUATION . 55
17.1 General . 55

– 4 – IEC TR 62366-2:2016 © IEC 2016
17.2 Conduct a SUMMATIVE EVALUATION . 56
17.3 Data collection . 57
17.3.1 General . 57
17.3.2 Observational data . 57
17.3.3 Subjective data .
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