AAMI TIR50:2014(R2025)
Current
Post-market surveillance of use error management
English
01-15-2026
The guidelines described in this technical information report (TIR) are not separate from or in opposition to the existing U.S. Food and Drug Administration’s (FDA’s) and other regulatory bodies' reporting protocols for product failure or adverse events (concerning morbidities or mortalities), which already have standardized protocols.
| DocumentType |
Standard
|
| ISBN |
9781570205149
|
| Pages |
46
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.