PD IEC/TR 62366-2:2016
Current
The latest, up-to-date edition.
Medical devices Guidance on the application of usability engineering to medical devices
Hardcopy , PDF
English
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.
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Together with BS EN 62366-1, it supersedes BS EN 62366 which remains current and will be withdrawn on 31/03/2018.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 |
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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