AAMI TIR50 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
Hardcopy , PDF
05-08-2020
English
01-01-2014
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Glossary of equivalent standards
Committee representation
Foreword
1 Purpose
2 Scope
3 Terms and definitions
4 How to use this document
5 Background
6 Regulatory focus on use error
post-market surveillance
7 Process recommendations for manufacturers
8 Process recommendations for clinical users
Annex A (informative) - Example questions for
collecting use error or close call data
Annex B (informative) - Connecting use
error to customer complaints
Bibliography
Covers the issue of use error detection for medical devices from the clinical, manufacturer, patient, user and regulatory perspective.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| PD IEC/TR 62366-2:2016 | Medical devices Guidance on the application of usability engineering to medical devices |
| AAMI TIR59:2017 | INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI IEC 62366 : 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
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