I.S. EN 62366-1:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Hardcopy , PDF
English
01-01-2015
22-08-2019
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.
National Foreword
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
Index of defined terms
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
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
|
| DevelopmentNote |
Supersedes I.S. EN 62366. (02/2016) For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-2281-2
|
| Pages |
122
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 62366-1:2015 | Identical |
| IEC 62366-1:2015 | Equivalent |
| BS EN 62366-1:2015 | Equivalent |
| UNE-EN 62366-1:2015 | Equivalent |
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