|
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)
|
07/09/2014 |
Sterility |
14-437 |
Complete |
ISO ASTM |
52701 First edition 2013-11-15 (R2020) |
Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing |
09/17/2018 |
Sterility |
14-512 |
Complete |
ISO |
13408-2 Second edition 2018-01 |
Aseptic processing of health care products - Part 2: Sterilizing filtration. |
ANSI AAMI ISO |
13408-2:2018 |
Aseptic processing of health care products - Part 2:Sterilizing filtration |
09/17/2018 |
Sterility |
14-275 |
Complete |
ANSI AAMI |
ST41:2008/(R)2018 |
Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
01/27/2015 |
Sterility |
14-165 |
Complete |
ISO |
14644-5 First edition 2004-08-15 |
Cleanrooms and associated controlled environments - Part 5: Operations |
07/09/2014 |
Sterility |
14-257 |
Complete |
ASTM |
D3078-02 (Reapproved 2021)e1 |
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
08/06/2013 |
Sterility |
14-383 |
Complete |
ISO ASTM |
51702 Third edition 2013-04-15 |
Practice for dosimetry in a gamma facility for radiation processing |
12/23/2016 |
Sterility |
14-500 |
Complete |
ISO |
14644-1 Second edition 2015-12-15 |
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration |
05/29/2023 |
Sterility |
14-584 |
Complete |
ASTM |
F2391-22 |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
08/21/2017 |
Sterility |
14-502 |
Complete |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
03/16/2012 |
Sterility |
14-332 |
Complete |
ISO |
11140-5 Second edition 2007-03-15 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
ANSI AAMI ISO |
11140-5:2007/(R)2012 |
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs |