| Item: |
Final |
| Document
Type: |
AAMI Technical Information Report |
| Abstract: |
Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, disinfection and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided, as are a bibliography and other informative annexes.
|
| Format: |
Print or Electronic |
| Number
of Pages: |
41 |
| Publication
Date: |
03/28/2005
|
|
Availability: | Actual |
|
Price (Member/Nonmember): |
$50/$100
|
|
PDF Price (Member/Nonmember): |
$50/$100
|
| Category: |
Sterilization |
| Subcategory: |
General and miscellaneous |
| Activity: |
STANDARDS |
| Keywords: |
cleaning, decontamination, disinfection, medical device design, sterilization
|
| Staff
Contact: |
sgillespie@aami.org |
| Project
Type: |
Revision |
| Project
Status: |
Completed |
| Document
Status: |
Current |
| Final
Approval Date: |
12/23/2004 |
| Equivalency: |
No equivalent IS |
| Ballot
Committee: |
AAMI/ST/WG 12, Instructions for reusable device reprocessing |
| Committee
Author: |
AAMI/ST/WG 12, Instructions for reusable device reprocessing |
| FDA Recognition: |
Cited as relevant guidance to FDA-recognized standard |
| Extent of Recognition: |
N/A |
| Link to FDA List: |
Choose Category "Sterility"
|