AAMI SW68 : 1ED 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
08-06-2006
12-01-2013
Defines a common framework for software life cycle processes, with well-defined terminology, that can be referenced by the medical device software industry. Also contains processes, activities, and tasks that are to be applied during the acquisition of a medical device that contains software, and a stand-alone software product, during the supply, development, and maintenance of software products.
| Committee |
SW
|
| DocumentType |
Standard
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| IEC 62304:2006+AMD1:2015 CSV | Identical |
| ASTM E 2538 : 2006 : R2011 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020) |
| AAMI TIR32 : 2004 : R2016 | MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
| ASTM E 2538 : 2006 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures |
| AAMI TIR32 :2004 | MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
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