CSA IEC 62366 : 2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
07-30-2021
English
01-01-2014
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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Withdrawn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 |
| 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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