I.S. EN 62366-1:2015/A1:2020
Current
The latest, up-to-date edition.
Medical devices - Part 1: Application of usability engineering to medical devices
Hardcopy , PDF
English
03-09-2020
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.
Dates of withdrawal of national standards are available from NSAI.
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
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| Pages |
172
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 62366-1:2015/AMD1:2020 | Identical |
| EN 62366-1:2015/A1:2020 | Identical |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 9241-11:2018 | Ergonomics of human-system interaction — Part 11: Usability: Definitions and concepts |
| ISO 7010:2019 | Graphical symbols — Safety colours and safety signs — Registered safety signs |
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