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AAMI TIR50 : 2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
Available format(s)

Hardcopy , PDF

Superseded date

05-08-2020

Language(s)

English

Published date

01-01-2014

Publisher

Association for the Advancement of Medical Instrumentation

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Superseded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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Hardcopy - English
PDF - English - DRM
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