|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
12/20/2021 |
Sterility |
14-569 |
Complete |
USP-NF |
M98810_01_01 |
<71> Sterility Tests |
12/20/2021 |
Sterility |
14-570 |
Complete |
USP-NF |
M98830_02_01 |
<85> Bacterial Endotoxins Test |
01/27/2015 |
Sterility |
14-389 |
Complete |
ISO |
14644-9 First edition 2012-08-15 |
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration |
01/27/2015 |
Sterility |
14-456 |
Complete |
ANSI AAMI ISO |
TIR16775:2014 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ISO |
TS 16775 First edition 2014-05-15 |
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
05/29/2023 |
Sterility |
14-587 |
Complete |
AAMI |
TIR104:2022 |
Guidance on transferring health care products between radiation sterilization sources |
01/15/2013 |
Sterility |
14-213 |
Complete |
AOAC |
6.2.03:2006 |
Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-215 |
Complete |
AOAC |
6.2.05:2006 |
Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method |
01/15/2013 |
Sterility |
14-217 |
Complete |
AOAC |
6.3.02:2006 |
Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes |
01/27/2015 |
Sterility |
14-243 |
Complete |
ISO |
14644-6 First edition 2007-07-15 |
Cleanrooms and associated controlled environments - Part 6: Vocabulary |
07/09/2014 |
Sterility |
14-433 |
Complete |
ASTM |
F2227-13 (Reapproved 2021) |
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method |