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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

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.

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.

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

Standards Relationship
IEC TR 62366-2:2016 Identical

ISO 9241-110:2006 Ergonomics of human-system interaction Part 110: Dialogue principles
ISO/TR 24971:2013 Medical devices Guidance on the application of ISO 14971
AAMI TIR50 : 2014 POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 16781:2013 Space systems Simulation requirements for control system
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
ISO/TS 19218-1:2011 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 14915-1:2002 Software ergonomics for multimedia user interfaces Part 1: Design principles and framework
ISO 14915-3:2002 Software ergonomics for multimedia user interfaces Part 3: Media selection and combination
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 82079-1:2012 Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements
AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS
ISO 14915-2:2003 Software ergonomics for multimedia user interfaces Part 2: Multimedia navigation and control

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