BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Application of usability engineering to medical devices
Hardcopy , PDF
English
31-01-2016
01-09-2020
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
Describes a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| Committee |
CH/62/1
|
| DevelopmentNote |
Supersedes 14/30244508 DC. (06/2015) Together with BS PD IEC TR 62366-2, it supersedes BS EN 62366 which remains current and will be withdrawn on 31/03/2018. (05/2016)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 62366-1:2015 | Identical |
| I.S. EN 62366-1:2015 | Equivalent |
| UNE-EN 62366-1:2015 | Equivalent |
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