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PD IEC/TR 62366-2:2016

Current

Current

The latest, up-to-date edition.

Medical devices Guidance on the application of usability engineering to medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

27-04-2016

€395.12
Excluding VAT
Summarise this standard

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

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.

Committee
CH/62/1
DevelopmentNote
Together with BS EN 62366-1, it supersedes BS EN 62366 which remains current and will be withdrawn on 31/03/2018. (05/2016)
DocumentType
Standard
Pages
108
PublisherName
British Standards Institution
Status
Current
Supersedes

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.

Standards Relationship
IEC TR 62366-2:2016 Identical

€395.12
Excluding VAT