| Item: |
Proposed Reaffirmation |
| Document
Type: |
AAMI/ American National Standard |
| Draft
Type: |
Standards Board Ballot Draft |
| Abstract: |
Specifies life cycle processes including software development, software maintenance, software risk management, software configuration management, and software problem resolution requirements for medical device software. Also requires manufacturers to assign one of three defined safety classes to the software system, and makes normative reference to ANSI/AAMI/ISO 14971, Application of risk management to medical devices.
|
| Format: |
Print or Electronic |
| Publication
Date: |
08/01/2012
|
|
Availability: | Actual |
|
Price (Member/Nonmember): |
$55/$110
|
|
PDF Price (Member/Nonmember): |
$55/$110
|
| Category: |
Software/Informatics |
| Subcategory: |
(none) |
| Activity: |
STANDARDS |
| Keywords: |
medical device, software, life cycle, processes
|
| Staff
Contact: |
hwoehrle@aami.org |
| Project
Type: |
Reaffirmation |
| Project
Status: |
Active (Maintenance) |
| Document
Status: |
Current |
| Final
Approval Date: |
08/20/2012 |
| Equivalency: |
Equivalency to IEC 62A/62304/Ed.1: Identical |
| Former Designations: |
SW68 |
| Ballot
Committee: |
AAMI/SM/WG 01, Medical device software WG |
| Committee
Author: |
IEC/SC 62A/JWG 03, Joint IEC/SC 62A-ISO/TC 210 WG: Medical device software (ISO/TC 210/JWG 02) |
| FDA Recognition: |
FDA-recognized |
| Extent of Recognition: |
Modified 2008-7-31. See FDA detail sheet for more information. |
| Link to FDA List: |
Choose Category "Software"
|