CSA IEC 62366 : 2014

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES

Available format(s): Hardcopy, PDF

Withdrawn date: 30-07-2021

Language(s): English

Published date: 01-01-2014

Publisher: Canadian Standards Association

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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

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Document Type	Standard
ISBN
Pages
Published
Publisher	Canadian Standards Association
Status	Withdrawn
Superseded By	CSA IEC 62366-1 : 2015 CSA IEC 62366-1:15 (R2020)

Standards Referencing This Book - (Show below) - (Hide below)

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

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