|
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)
|
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
04/04/2016 |
Sterility |
14-333 |
Complete |
ISO |
17665-1 First edition 2006-08-15 |
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
ANSI AAMI ISO |
17665-1:2006/(R)2013 |
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
09/17/2018 |
Sterility |
14-517 |
Complete |
ASTM |
F3293-18 |
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices |
05/30/2022 |
Sterility |
14-573 |
Complete |
ASTM |
F88/F88M-21 |
Standard Test Method for Seal Strength of Flexible Barrier Materials |
12/18/2023 |
Sterility |
14-597 |
Complete |
AAMI ANSI |
ST108:2023 |
Water for the processing of medical devices |
09/09/2008 |
Sterility |
14-191 |
Complete |
ISO |
13408-4 First edition 2005-11-01 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
ANSI AAMI ISO |
13408-4:2005/(R)2014 |
Aseptic processing of health care products - Part 4: Clean-in-place technologies |
09/09/2008 |
Sterility |
14-240 |
Complete |
ISO |
13408-5 First edition 2006-11-15 |
Aseptic processing of health care products - Part 5: Sterilization-in-place |
ANSI AAMI ISO |
13408-5:2006/(R)2015 |
Aseptic processing of health care products - Part 5: Sterilization in place |
07/15/2019 |
Sterility |
14-531 |
Complete |
ISO |
11607-2 Second edition 2019-02 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
ANSI AAMI ISO |
11607-2:2019 |
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
06/07/2018 |
Sterility |
14-510 |
Complete |
ISO |
11137-3 Second edition 2017-06 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
ANSI AAMI ISO |
11137-3:2017/(R)2023 |
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control |
04/04/2016 |
Sterility |
14-277 |
Complete |
ANSI AAMI ISO |
TIR 17665-2:2009 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 |
ISO |
TS 17665-2 First edition 2009-01-15 |
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |