| Item: |
Final |
| Document
Type: |
AAMI Technical Information Report |
| Abstract: |
AAMI/ISO TIR22442-4 addresses methods of elimination and inactivation of transmissible spongiform encephalopathies (TSE agents) from animal tissues to be used in medical devices.
The methods addressed will include those designed for: [1] inactivating infectivity (preferred method to reduce opportunities for cross-contamination); and [2] physically removing TSE agents (without complete inactivation). Includes inactivation and elimination methods to be used in the product manufacturing process and in facilities and equipment designed for utilizing animal tissue products. (22442-4)
|
| Format: |
Print or Electronic |
| Number
of Pages: |
16 |
| Publication
Date: |
11/14/2011
|
|
Availability: | Actual |
|
Price (Member/Nonmember): |
$40/$80
|
|
PDF Price (Member/Nonmember): |
$40/$80
|
| Category: |
Biological evaluation |
| Subcategory: |
(none) |
| Activity: |
STANDARDS |
| Keywords: |
TSE, elimination, inactivation, tissue, bovine, animal
|
| Staff
Contact: |
sgillespie@aami.org |
| Project
Type: |
New document |
| Project
Status: |
Completed |
| Document
Status: |
Current |
| Final
Approval Date: |
03/06/2011 |
| Equivalency: |
Equivalency to ISO TR 22442-04/Ed.1: Identical |
| Ballot
Committee: |
AAMI/TS/WG 04, TSE elimination |
| Committee
Author: |
ISO/TC 194/SC 1/WG 04, TSE elimination |