IEC TR 62366-2:2016

Text FieldTextLanguageType
TitleMEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICESENOFFICIAL
SummaryGives 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.ENOFFICIAL
ContentFOREWORD
INTRODUCTION
1 Scope and 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
6 How to implement a USABILITY ENGINEERING program
7 Overview of the USABILITY ENGINEERING PROCESS
8 Prepare the USE SPECIFICATION
9 Identify USER INTERFACE characteristics related
to SAFETY and potential USE ERRORS
10 Identify known or foreseeable HAZARDS and HAZARDOUS
SITUATIONS
11 Identify and describe HAZARD-RELATED USE SCENARIOS
12 Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE
EVALUATION
13 Establish USER INTERFACE SPECIFICATION
14 Establish USER INTERFACE EVALUATION plan
15 Design and implement the USER INTERFACE and training
16 Perform FORMATIVE EVALUATIONS
17 Perform SUMMATIVE EVALUATION
18 Document the USABILITY ENGINEERING project
19 POST-PRODUCTION review and analysis
Annex A (informative) - Recommended reading list
Annex B (informative) - External resources to identify
known problems
Annex C (informative) - Developing USABILITY GOALS for
commercial purposes
Annex D (informative) - USABILITY ENGINEERING project
end products
Annex E (informative) - USABILITY ENGINEERING methods
Annex F (informative) - USABILITY ENGINEERING studies
in clinical settings
Annex G (informative) - USER PROFILE
Annex H (informative) - USE ENVIRONMENT descriptions
Annex I (informative) - USER INTERFACE REQUIREMENTS
Annex J (informative) - Model the USER INTERFACE
Annex K (informative) - USABILITY TEST sample size
Annex L (informative) - Identifying distinct USER groups
Bibliography
Index of defined terms

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.