IEC TR 62366-2 : 1ED 2016

MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

International Electrotechnical Committee

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FOREWORD 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

Abstract

Gives 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.