AAMI TIR50:2014(R2025)
Current
Current
The latest, up-to-date edition.
Post-market surveillance of use error management
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
15-01-2026
€192.96
Excluding VAT
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 ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
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