I.S. EN 62366:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
13-01-2016
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definition
4 Principals
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
Annex K (normative) - Evaluation of a USER INTERFACE OF
UNKNOWN PROVENANCE (UOUP)
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EC Directives
Bibliography
Index of defined terms
Describes 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 |
220
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 62366 : 2008 AMD 1 2015 | Identical |
| IEC 62366:2007+AMD1:2014 CSV | Identical |
| 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 |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 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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