|
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)
|
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 |
07/15/2019 |
Sterility |
14-528 |
Complete |
ISO |
11137-1 First edition 2006-04-15 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)] |
ANSI AAMI ISO |
11137-1:2006/(R)2015 |
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
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 |
02/20/2023 |
Sterility |
14-575 |
Complete |
ASTM |
F1980-21 |
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
12/21/2020 |
Sterility |
14-553 |
Complete |
ASTM |
F2097-20 |
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products |
01/30/2014 |
Sterility |
14-412 |
Complete |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
05/29/2023 |
Sterility |
14-586 |
Complete |
ISO |
22441 First edition 2022-08 |
Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
05/29/2024 |
Sterility |
14-600 |
Complete |
ASTM |
F1929-23 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
06/27/2015 |
Sterility |
14-484 |
Complete |
ASTM |
F1929-15 |
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |