| Item: |
Proposed Reaffirmation |
| Document
Type: |
AAMI/ American National Standard |
| Draft
Type: |
Standards Board Ballot Draft |
| Abstract: |
Specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. This standard does not specify acceptable risk levels.
|
| Format: |
Print or Electronic |
| Publication
Date: |
08/20/2010
|
|
Availability: | Actual |
|
Price (Member/Nonmember): |
$55/$110
|
|
PDF Price (Member/Nonmember): |
$55/$110
|
| Category: |
General aspects of medical devices |
| Subcategory: |
(none) |
| Activity: |
STANDARDS |
| Keywords: |
risk management, hazard
|
| Staff
Contact: |
hwoehrle@aami.org |
| Project
Type: |
Reaffirmation |
| Project
Status: |
Active (Maintenance) |
| Document
Status: |
Current |
| Equivalency: |
Identical |
| Ballot
Committee: |
AAMI/QM/WG 04, Application of risk management to medical devices |
| Committee
Author: |
ISO/TC 210/JWG 01, Joint ISO/TC 210-IEC/SC 62A WG: Application of risk management to medical devices (IEC/SC 62A/JWG 01) |
| FDA Recognition: |
FDA-recognized |
| Extent of Recognition: |
Complete standard |
| Link to FDA List: |
Choose Category "General"
|