AAMI TIR38:2019
Current
Current
The latest, up-to-date edition.
Medical device safety assurance case guidance
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
25-01-2019
€237.50
Excluding VAT
This technical information report provides guidance on how to complete an Assurance Case Report in order to comply with the new additional FDA pre-market requirements for infusion pumps.
| DocumentType |
Guide
|
| ISBN |
978-1-57020-712-9
|
| Pages |
51
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ANSI/AAMI/ISO 14971:2007/(R)2016
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| ISO/IEC 15026-1:2013 | Systems and software engineering — Systems and software assurance — Part 1: Concepts and vocabulary |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| ISO/IEC 15026-2:2011 | Systems and software engineering — Systems and software assurance — Part 2: Assurance case |
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