AAMI IEC 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
English
01-01-2015
27-08-2020
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of IEC 62366-1:2015
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
Defines a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY.
| DevelopmentNote |
Supersedes AAMI IEC 62366. (11/2017) NEW CHILD AMD 1 2020 IS NOW ADDED
|
| DocumentType |
Standard
|
| Pages |
80
|
| ProductNote |
NEW CHILD AMD 1 2020 IS NOW ADDED
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
A newer version of this standard is available.
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