|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
12/23/2016 |
Sterility |
14-169 |
ASTM |
F2391-05 (Reapproved 2016) |
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
01/30/2014 |
Sterility |
14-413 |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
01/27/2015 |
Sterility |
14-242 |
ISO |
14644-3 First edition 2005-12-15 |
Cleanrooms and associated controlled environments - Part 3: Test methods |
01/30/2014 |
Sterility |
14-429 |
ASTM ISO |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
01/27/2015 |
Sterility |
14-379 |
ISO |
14644-8 Second edition 2013-02-15 |
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) |
08/21/2017 |
Sterility |
14-501 |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
08/21/2017 |
Sterility |
14-502 |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
01/30/2014 |
Sterility |
14-424 |
ANSI AAMI ISO |
13408-6:2005/(R) 2013 & A1:2013 |
Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)] |
ISO |
13408-6 First edition 2005-06-15 |
Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)] |
01/30/2014 |
Sterility |
14-427 |
ANSI AAMI ISO |
13408-1:2008 (R2011) |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
04/04/2016 |
Sterility |
14-409 |
ANSI AAMI ISO |
11137-2:2013 |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |
ISO |
11137-2 Third edition 2013-06-01 |
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose |