CSA IEC 62366 : 2014

Withdrawn

View Superseded by

MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Withdrawn date

07-30-2021

Language(s)

English

Published date

01-01-2014

Publisher

Canadian Standards Association

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Principles
5 USABILITY ENGINEERING PROCESS
6 ACCOMPANYING DOCUMENT
7 Training and materials for training
Annex A (informative) - General guidance and rationale
Annex B (informative) - Categories of USER action
Annex C (informative) - Examples of USE ERRORS, ABNORMAL
        USE and possible causes
Annex D (informative) - Guidance on the USABILITY ENGINEERING
        PROCESS
ANNEX E (informative) - Questions that can be used to identify
        MEDICAL DEVICE characteristics associated with USABILITY
        that could impact on SAFETY
ANNEX F (informative) - Examples of possible USABILITY related
        HAZARDOUS SITUATIONS
Annex G (informative) - USABILITY goals: Illustrative example
        for a home parenteral infusion pump
ANNEX H (informative) - Sample USABILITY SPECIFICATION and
        its inputs
Annex I (informative) - Recommended reading list
Annex J (informative) - Reference to the essential principles
Bibliography
Index of defined terms

Defines a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE.

DocumentType	Standard
Pages	240
PublisherName	Canadian Standards Association
Status	Withdrawn
SupersededBy	CSA IEC 62366-1 : 2015 CSA IEC 62366-1:15 (R2020)

ISO 9241-11:1998	Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
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
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
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
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