CSA IEC 62366-1 : 2015

Superseded

View Superseded by

MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

12-18-2020

Language(s)

English

Published date

01-01-2015

Publisher

Canadian Standards Association

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
Annex A (informative) - General guidance and rationale
ANNEX B (informative) - Examples of possible HAZARDOUS
        SITUATIONS related to USABILITY
Annex C (normative) - Evaluation of a USER INTERFACE OF
        UNKNOWN PROVENANCE (UOUP)
Annex D (informative) - Types of MEDICAL DEVICE use,
        with examples
Annex E (informative) - Reference to the essential
        principles
Bibliography
Index of defined terms

Defines a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.

DevelopmentNote	Supersedes CSA IEC 62366. (11/2015)
DocumentType	Standard
Pages	135
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA IEC 62366-1:15 (R2020)
Supersedes	CSA IEC 62366 : 2014

ISO 9241-11:1998	Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
AAMI HE48 : 1993	HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
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
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/IEC Guide 63:2012	Guide to the development and inclusion of safety aspects in International Standards for medical devices
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices
IEC TR 61258:2008	Guidelines for the development and use of medical electrical equipment educational materials