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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
08-05-2020
English
01-01-2014
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
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.